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Mwale O, Kasambala C, Houde A, Mpinga K, Kayira W, Harawa M, Kamwiyo M, Isaacs R, Nhlema B, Ruderman T, Liwimbi O, Udedi M, Kelly K, McBain RK. Patient perspectives on group problem management plus for adults with major depressive disorder in rural Malawi. Glob Health Action 2025; 18:2500785. [PMID: 40340587 PMCID: PMC12068342 DOI: 10.1080/16549716.2025.2500785] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/06/2024] [Accepted: 04/28/2025] [Indexed: 05/10/2025] Open
Abstract
BACKGROUND Major depressive disorder (MDD) frequently co-occurs with other medical conditions. Care integration and task shifting are two frameworks that may strengthen person-centered care among individuals with MDD and comorbid diagnoses, including for adults with limited access to healthcare resources living in rural settings within sub-Saharan Africa. OBJECTIVE We assessed the acceptability and feasibility of group psychotherapy (Problem Management Plus [PM+]) integrated into chronic healthcare services in Neno District, based on key informant (KI) interviews with clients who received PM+ services from local counselors. METHODS We conducted in-depth interviews with 31 KIs, comprising adult patients participating in group PM+ in rural Malawi. The interview covered facets such as knowledge acquisition, logistical considerations for organizing PM+ sessions, selection of appropriate venues, session format, and overall perceived acceptability. Themes were identified through thematic content analysis. RESULTS We identified five emergent themes: limited prior awareness and understanding of MDD, positive elements of the PM+ service delivery model, patients' perceived effectiveness of PM+, logistical challenges with effectively engaging PM+, and positive views on acceptability of PM+. Findings revealed a strong appreciation and enthusiasm for PM+, although KIs noted areas for improvement - including lengthy travel times to receive PM+, limited compensation and privacy, and counselors arriving late. CONCLUSION Insights from clients underscore the potential utility of group PM+ as a task-shifted model of MDD care that can be integrated into existing service packages in resource-limited settings, as well as opportunities for improvements such as reducing travel time to care and identifying venues with greater client privacy. TRIAL REGISTRATION ClinicalTrials.gov identifier: NCT04777006.
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Affiliation(s)
| | | | - Amruta Houde
- Ministry of Health, Zomba Mental Hospital, Zomba, Malawi
| | | | | | | | | | - Rachel Isaacs
- Ministry of Health, Zomba Mental Hospital, Zomba, Malawi
| | | | | | - Olive Liwimbi
- Clinical Services, Ministry of Health, Lilongwe, Malawi
| | | | - Ksakrad Kelly
- Ministry of Health, Zomba Mental Hospital, Zomba, Malawi
| | - Ryan K. McBain
- Healthcare Delivery, RAND Corporation, Washington, DC, USA
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Buschner A, Makiol C, Huang J, Mauche N, Strauß M. Comparison of cognitive behavioral therapy and third-wave-mindfulness-based therapies for patients suffering from depression measured using the Beck-Depression-Inventory (BDI): A systematic literature review and network-meta-analysis. J Affect Disord 2025; 379:88-99. [PMID: 40054534 DOI: 10.1016/j.jad.2025.02.104] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/17/2024] [Revised: 02/13/2025] [Accepted: 02/27/2025] [Indexed: 04/12/2025]
Abstract
BACKGROUND Mindfulness-based therapies (MBT) are proposed as a "third wave" of cognitive-behavioral therapy (CBT). This network meta-analysis investigated this hypothesis by comparing the effectiveness of MBT and CBT for treating depression, measured by the Beck Depression Inventory-II (BDI-II). METHODS An indirect comparison was made. Relevant databases were searched for studies comparing either CBT or MBT with treatment as usual (TAU). Mean differences (MD) between intervention and TAU were calculated using changes from baseline from both intervention (Me) and TAU-group (Mc). MDs of CBT and MBT were compared in a network meta-analysis. Results were reported for both the common-effects-model (CEM) and the random-effects-model (REM). Risk of Bias (RoB) was measured using the RoB-2-tool. Quality of evidence was investigated based on GRADE. RESULTS Eight MBT and ten CBT studies, meeting eligibility since 2006, were included. MBT studies included behavioral activation with mindfulness, mindfulness-based cognitive therapy, person-based cognitive therapy, and a newly developed meditation-based lifestyle modification program. Both CBT and MBT differed significantly from TAU. In the unweighted CEM network meta-analysis, MBT showed significantly better treatment effect, but this was below the clinically relevant threshold (MD:-1.81). For REM and weighted analysis, there were no significant differences between CBT and MBT. LIMITATIONS Heterogeneity, high RoB, and low evidence quality were notable, with indirectness limiting this analysis. CONCLUSIONS CBT and MBT both showed significant and clinically important treatment effects for depression. However, an outstanding benefit of MBT in comparison to CBT could not be found in this analysis. Further research could include a direct comparison.
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Affiliation(s)
- Alexander Buschner
- Department of Psychiatry and Psychotherapy, Faculty of Medicine, Leipzig University, Leipzig, Germany
| | - Christian Makiol
- Department of Psychiatry and Psychotherapy, Faculty of Medicine, Leipzig University, Leipzig, Germany
| | - Jue Huang
- Department of Psychiatry and Psychotherapy, Faculty of Medicine, Leipzig University, Leipzig, Germany
| | - Nicole Mauche
- Department of Psychiatry and Psychotherapy, Faculty of Medicine, Leipzig University, Leipzig, Germany.
| | - Maria Strauß
- Department of Psychiatry and Psychotherapy, Faculty of Medicine, Leipzig University, Leipzig, Germany; Department of Psychiatry and Psychotherapy, University of Leipzig Medical Center, Leipzig, Germany
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Hildebrand AS, Planert J, Roesmann K, Machulska A, Neubert M, Klucken T. Fear not: Combining digital and virtual reality interventions for the treatment of social anxiety disorder - a randomized controlled trial. Behav Res Ther 2025; 188:104731. [PMID: 40147246 DOI: 10.1016/j.brat.2025.104731] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/21/2024] [Revised: 02/22/2025] [Accepted: 03/17/2025] [Indexed: 03/29/2025]
Abstract
INTRODUCTION Social anxiety disorder (SAD) poses a significant mental health challenge. Despite cognitive behavior therapy being the first-line treatment for SAD, its accessibility remains limited. Internet- and mobile-based interventions (IMIs) offer approaches to enhance accessibility and reduce waiting times. As part of this, some recent approaches have incorporated virtual reality (VR) to enable behavioral experiments and exposure. This pilot study aimed to explore the efficacy of an IMI, including CBT interventions via smartphone apps and VR to alleviate the severity of SAD symptoms. METHODS Thirty-two patients diagnosed with SAD were randomly assigned to either an experimental group (n = 16) receiving the IMI or an active control group (n = 16). The number of therapeutic appointments was held constant across conditions to account for unspecific treatment effects. The primary outcome was SAD severity, obtained at baseline, interim, post-treatment, and follow-up assessments. The secondary outcome remission was evaluated through a diagnostic interview at follow-up. The trial was registered with ISRCTN (ID: ISRCTN18013983). RESULTS Regarding the differential effectiveness between the active control condition and the IMI, two different results were found: There was a higher remission rate in the experimental group compared to the control group, while no significant differences in SAD severity were found. CONCLUSION While SAD severity showed a comparable reduction in both groups, significantly fewer patients in the experimental group were still diagnosed with SAD at follow-up. This suggested a difference between self-report and clinical evaluation. Despite the mixed results, IMIs provide a low-barrier intervention and could be used to increase access to therapy and reduce waiting times.
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Affiliation(s)
- Anne Sophie Hildebrand
- Department of Clinical Psychology and Psychotherapy, University of Siegen, Siegen, Germany.
| | - Jari Planert
- Department of Clinical Psychology and Psychotherapy, University of Siegen, Siegen, Germany.
| | - Kati Roesmann
- Clinical Psychology and Psychotherapy in Childhood and Adolescence, Institute of Psychology, University of Osnabrück, Osnabrück, Germany.
| | - Alla Machulska
- Department of Clinical Psychology and Psychotherapy, University of Siegen, Siegen, Germany.
| | - Marie Neubert
- Department of Clinical Psychology and Psychotherapy, University of Siegen, Siegen, Germany.
| | - Tim Klucken
- Department of Clinical Psychology and Psychotherapy, University of Siegen, Siegen, Germany.
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Meyer B, Riepenhausen A, Betz LT, Jauch-Chara K, Reshetnik A. Internet-based digital intervention to support the self-management of hypertension compared to usual care: results of the HALCYON randomized controlled trial. BMC Cardiovasc Disord 2025; 25:256. [PMID: 40186109 PMCID: PMC11971814 DOI: 10.1186/s12872-025-04698-5] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/28/2024] [Accepted: 03/21/2025] [Indexed: 04/07/2025] Open
Abstract
BACKGROUND Hypertension is a major public health problem. Despite existing treatment options, overall blood pressure control is still insufficient. Digital health interventions have the potential to improve treatment success. We developed liebria, an internet-based digital intervention accessible via smartphones and computers, designed to support the self-management of hypertension. METHODS We tested the effectiveness of liebria in reducing systolic blood pressure and improving other relevant endpoints in adults with hypertension using a parallel randomized controlled trial design. Adults with hypertension (mean age 54.5 years, 47.1% male) were recruited via a German health insurance provider and randomized (1:1; concealed allocation; no blinding of participants) to receive liebria in addition to treatment as usual (n = 52), or treatment as usual alone (n=50). Primary outcome was systolic blood pressure after 3 months (T1). Secondary endpoints were diastolic blood pressure, pulse pressure, quality of life, medication adherence, and social and work-related functioning. RESULTS The study's statistical power was limited due to a smaller sample size (N = 102) than the a priori target sample size (N=676). Intention-to-treat analyses showed an effect of liebria on systolic blood pressure (baseline-adjusted between-group difference -3.5 mmHg, 95% CI -7.13 to 0.13, p = .053, Cohen's d = 0.36). More participants in the intervention group (78.2% vs. 54.3% in the control group) showed reductions in systolic blood pressure (p = .076). Moreover, liebria had effects on social and work-related functioning. No effects emerged for diastolic blood pressure, pulse pressure, quality of life, or medication adherence. No adverse events or device effects were observed. CONCLUSIONS The present study shows first promising results of liebria's effects on systolic blood pressure and social and work-related functioning. Future studies should aim to replicate effects in a larger sample to increase statistical power. TRIAL REGISTRATION German Clinical Trials Register (DRKS00025871); https://drks.de/search/en/trial/DRKS00025871 ; date of registration: October 5, 2021.
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Affiliation(s)
| | | | | | | | - Alexander Reshetnik
- Department of Nephrology and Intensive Care Medicine, Charité, Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany
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Barrett DW, Beevers CG, Gonzalez-Lima F. Augmenting Internet-Based Cognitive Behavioral Therapy for Major Depressive Disorder With Transcranial Infrared Laser Stimulation. BIOLOGICAL PSYCHIATRY GLOBAL OPEN SCIENCE 2025; 5:100449. [PMID: 39990627 PMCID: PMC11847300 DOI: 10.1016/j.bpsgos.2025.100449] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/25/2024] [Revised: 11/22/2024] [Accepted: 12/22/2024] [Indexed: 02/25/2025] Open
Abstract
Background Transcranial infrared laser stimulation (TILS) is a noninvasive form of photobiomodulation that facilitates prefrontal energy metabolism and oxygenation, resulting in cognitive-enhancing effects. Cognitive behavioral therapy is a mainstream treatment for major depressive disorder. This is the first study to investigate whether TILS would augment the antidepressant effects of internet-based cognitive behavioral therapy. Methods Sixty participants with major depressive disorder were given access to Deprexis, a form of internet-based cognitive behavioral therapy, for 12 weeks. After the first 2 weeks, the 40 participants who had improved at least 10% in depressive symptoms from baseline as measured by the Quick Inventory of Depressive Symptomatology-Self-Report were randomly assigned to Deprexis in combination with TILS or sham/placebo. There were no significant group differences in demographics or initial depression data. Results There was a 43% reduction in Quick Inventory of Depressive Symptomatology-Self-Report scores in the sham group from the initial score to the week 12 score, while adding TILS as an adjunct therapy resulted in a reduction of 56%. Therefore, TILS resulted in an additional 30% reduction in Quick Inventory of Depressive Symptomatology-Self-Report scores ([56-43]/43 = 30%). Participants who received TILS to the right forehead once a week for 4 weeks showed a significantly greater reduction of depressive symptoms than participants who received sham/placebo. Participants reported no adverse effects. Conclusions While Deprexis alone significantly reduced depression scores in the placebo control group, this beneficial effect was augmented with the addition of TILS as an adjunct therapy. Additional research that pairs neuroenhancement methods such as TILS with cognitive interventions may reveal the potential to improve treatment outcomes in depression and other psychiatric disorders.
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Affiliation(s)
- Douglas W. Barrett
- Departments of Psychology, Psychiatry and Behavioral Sciences, and Institute for Neuroscience, The University of Texas at Austin, Austin, Texas
| | - Christopher G. Beevers
- Departments of Psychology, Psychiatry and Behavioral Sciences, and Institute for Neuroscience, The University of Texas at Austin, Austin, Texas
| | - F. Gonzalez-Lima
- Departments of Psychology, Psychiatry and Behavioral Sciences, and Institute for Neuroscience, The University of Texas at Austin, Austin, Texas
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Hildebrand AS, Planert J, Machulska A, Margraf LM, Roesmann K, Klucken T. Exploring Psychotherapists' Attitudes on Internet- and Mobile-Based Interventions in Germany: Thematic Analysis. JMIR Form Res 2024; 8:e51832. [PMID: 39510514 PMCID: PMC11582492 DOI: 10.2196/51832] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/14/2023] [Revised: 02/07/2024] [Accepted: 07/16/2024] [Indexed: 11/15/2024] Open
Abstract
BACKGROUND In recent years, internet- and mobile-based interventions (IMIs) have become increasingly relevant in mental health care and have sparked societal debates. Psychotherapists' perspectives are essential for identifying potential opportunities for improvement, facilitating conditions, and barriers to the implementation of these interventions. OBJECTIVE This study aims to explore psychotherapists' perspectives on opportunities for improvement, facilitating conditions, and barriers to using IMIs. METHODS The study used a qualitative research design, utilizing open-ended items in a cross-sectional survey. A total of 350 psychotherapists were asked to provide their written opinions on various aspects of IMIs. Thematic analysis was conducted to analyze the data and identify core themes. RESULTS The analysis revealed 11 core themes related to the use of IMIs, which were categorized into 4 superordinate categories: "Applicability," "Treatment Resources," "Technology," and "Perceived Risks and Barriers." While many psychotherapists viewed IMIs as a valuable support for conventional psychotherapy, they expressed skepticism about using IMIs as a substitute. Several factors were perceived as hindrances to the applicability of IMIs in clinical practice, including technological issues, subjective concerns about potential data protection risks, a lack of individualization due to the manualized nature of most IMIs, and the high time and financial costs for both psychotherapists and patients. They expressed a desire for easily accessible information on evidence and programs to reduce the time and effort required for training and advocated for this information to be integrated into the conceptualization of new IMIs. CONCLUSIONS The findings of this study emphasize the importance of considering psychotherapists' attitudes in the development, evaluation, and implementation of IMIs. This study revealed that psychotherapists recognized both the opportunities and risks associated with the use of IMIs, with most agreeing that IMIs serve as a tool to support traditional psychotherapy rather than as a substitute for it. Furthermore, it is essential to involve psychotherapists in discussions about IMIs specifically, as well as in the development of new methodologies in psychotherapy more broadly. Overall, this study can advance the use of IMIs in mental health care and contribute to the ongoing societal debate surrounding these interventions.
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Affiliation(s)
- Anne Sophie Hildebrand
- Department of Clinical Psychology and Psychotherapy, University of Siegen, Siegen, Germany
| | - Jari Planert
- Department of Clinical Psychology and Psychotherapy, University of Siegen, Siegen, Germany
| | - Alla Machulska
- Department of Clinical Psychology and Psychotherapy, University of Siegen, Siegen, Germany
| | - Lena Maria Margraf
- Department of Clinical Psychology and Psychotherapy, University of Siegen, Siegen, Germany
| | - Kati Roesmann
- Unit of Clinical Psychology and Psychotherapy in Childhood and Adolescence, Department of Psychology, University of Osnabrück, Osnabrück, Germany
| | - Tim Klucken
- Department of Clinical Psychology and Psychotherapy, University of Siegen, Siegen, Germany
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Castro O, Salamanca-Sanabria A, Alattas A, Teepe GW, Leidenberger K, Fleisch E, Tudor Car L, Muller-Riemenschneider F, Kowatsch T. Top-funded companies offering digital health interventions for the prevention and treatment of depression: a systematic market analysis. Arch Public Health 2024; 82:200. [PMID: 39497184 PMCID: PMC11533405 DOI: 10.1186/s13690-024-01424-z] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/14/2024] [Accepted: 10/14/2024] [Indexed: 11/06/2024] Open
Abstract
BACKGROUND Digital innovations can reduce the global burden of depression by facilitating timely and scalable interventions. In recent years, the number of commercial Digital Health Interventions for Depression (DHIDs) has been on the rise. However, there is limited knowledge on their content and underpinning scientific evidence. This study aimed to: (i) identify the top-funded companies offering DHIDs and (ii) provide an overview of their interventions, including scientific evidence, psychotherapeutic approaches and use of novel technologies. METHODS A systematic search was conducted using two venture capital databases to identify the top-30 funded companies offering DHIDs. In addition, studies related to the DHIDs' were identified via academic databases and hand-searching. The methodological quality of the publications was evaluated using the Mixed Methods Appraisal Tool. RESULTS The top-30 funded companies offering DHIDs received a total funding of 2,592 million USD. Less than half of the companies produced any scientific research associated with their DHIDs, with a total of 83 publications identified. Twenty-five publications were randomised control trials, of which 15 reported moderate-to-large effects in reducing depression symptoms. Regarding novel technologies, few DHIDs incorporated the use of conversational agents or low-burden sensing technologies. CONCLUSIONS Funding received by top-funded companies was not related to the amount of scientific evidence provided on their DHIDs. There was a strong variation in the quantity of evidence produced and an overall need for more rigorous effectiveness trials. Few DHIDs used automated approaches such as conversational agents, limiting their scalability.
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Affiliation(s)
- Oscar Castro
- Future Health Technologies, Campus for Research Excellence and Technological Enterprise (CREATE), Singapore-ETH Centre, Singapore, Singapore.
| | - Alicia Salamanca-Sanabria
- Future Health Technologies, Campus for Research Excellence and Technological Enterprise (CREATE), Singapore-ETH Centre, Singapore, Singapore
- Singapore Institute for Clinical Sciences, Agency for Science, Technology and Research (A*STAR), Singapore, Singapore
| | - Aishah Alattas
- Future Health Technologies, Campus for Research Excellence and Technological Enterprise (CREATE), Singapore-ETH Centre, Singapore, Singapore
| | - Gisbert Wilhelm Teepe
- Centre for Digital Health Interventions, Department of Management, Technology and Economics, ETH Zurich, Zurich, Switzerland
| | - Konstantin Leidenberger
- Centre for Digital Health Interventions, Institute of Technology Management, University of St. Gallen, St. Gallen, Switzerland
| | - Elgar Fleisch
- Future Health Technologies, Campus for Research Excellence and Technological Enterprise (CREATE), Singapore-ETH Centre, Singapore, Singapore
- Centre for Digital Health Interventions, Department of Management, Technology and Economics, ETH Zurich, Zurich, Switzerland
- Centre for Digital Health Interventions, Institute of Technology Management, University of St. Gallen, St. Gallen, Switzerland
| | - Lorainne Tudor Car
- Family Medicine and Primary Care, Lee Kong Chian School of Medicine, Nanyang Technological University, Singapore, Singapore
- Department of Primary Care and Public Health, School of Public Health, Imperial College London, London, UK
| | - Falk Muller-Riemenschneider
- Saw Swee Hock School of Public Health National University of Singapore, Singapore, Singapore
- Digital Health Center, Berlin Institute of Health, Charité-Universitätsmedizin Berlin, Berlin, Germany
| | - Tobias Kowatsch
- Future Health Technologies, Campus for Research Excellence and Technological Enterprise (CREATE), Singapore-ETH Centre, Singapore, Singapore
- Centre for Digital Health Interventions, Department of Management, Technology and Economics, ETH Zurich, Zurich, Switzerland
- Centre for Digital Health Interventions, Institute for Implementation Science in Health Care, University of Zurich, Zurich, Switzerland
- Centre for Digital Health Interventions, School of Medicine, University of St. Gallen, St. Gallen, Switzerland
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Kalde J, Atik E, Stricker J, Schückes M, Neudeck P, Pittig A, Pietrowsky R. Enhancing the effectiveness of CBT for patients with unipolar depression by integrating digital interventions into treatment: A pilot randomized controlled trial. Psychother Res 2024; 34:1131-1146. [PMID: 37922395 DOI: 10.1080/10503307.2023.2277866] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/05/2023] Open
Abstract
OBJECTIVE Blended cognitive behavioral therapy (bCBT) combines face-to-face therapy with digital elements, such as digital health apps. This pilot study aimed to explore the effectiveness and safety of a novel bCBT application for treating unipolar depression in adults combined with cognitive behavioral therapy (CBT) compared to CBT alone in routine care. METHODS Patients (N = 82) were randomly assigned to bCBT (n = 42) or CBT (n = 40) over 12 weeks. bCBT consisted of weekly CBT sessions accompanied by the elona therapy depression module (a bCBT application for unipolar depression) for use between sessions. Standard CBT consisted of weekly CBT sessions. Outcomes (6,12 weeks) were analyzed with linear mixed models. RESULTS Improvements in depressive symptoms (BDI-II, PHQ-9) were descriptively larger for the bCBT group. Yet, this difference did not reach statistical significance. bCBT was superior to standard CBT in secondary outcome measures of psychological health (d = .50) and generalized anxiety symptoms (d = -.45). In other secondary outcomes (BAI, PSWQ, GSE, WHOQOL-BREF), improvements were descriptively larger for bCBT compared to CBT. CONCLUSION This pilot study provided preliminary evidence that bCBT might be advantageous in comparison to CBT alone in the treatment of depression, but larger RCTs of the bCBT application are needed.
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Affiliation(s)
- Jan Kalde
- Department of Experimental Psychology, Heinrich-Heine-University Düsseldorf, Düsseldorf, Germany
| | - Ece Atik
- Elona Health GmbH, Düsseldorf, Germany
- Translational Psychotherapy, Georg-Elias-Mueller-Institute of Psychology, University of Goettingen, Göttingen, Germany
| | - Johannes Stricker
- Department of Experimental Psychology, Heinrich-Heine-University Düsseldorf, Düsseldorf, Germany
| | | | - Peter Neudeck
- Elona Health GmbH, Düsseldorf, Germany
- Department of Clinical Psychology, Technical University Chemnitz, Chemnitz, Germany
| | - Andre Pittig
- Translational Psychotherapy, Georg-Elias-Mueller-Institute of Psychology, University of Goettingen, Göttingen, Germany
| | - Reinhard Pietrowsky
- Department of Experimental Psychology, Heinrich-Heine-University Düsseldorf, Düsseldorf, Germany
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Edelbluth S, Klein JP, Schwartz B, Hehlmann M, Arndt A, Rubel J, Moggia D, Berger T, Meyer B, Moritz S, Schröder J, Lutz W. The long shadow of early-change patterns: a 3-year follow-up after the use of a web-based intervention for mild to moderate depressive symptoms. Cogn Behav Ther 2024; 53:681-700. [PMID: 38912859 DOI: 10.1080/16506073.2024.2368520] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/25/2023] [Accepted: 05/31/2024] [Indexed: 06/25/2024]
Abstract
Web-based interventions can be effective in treating depressive symptoms. Patients with risk not responding to treatment have been identified by early change patterns. This study aims to examine whether early changes are superior to baseline parameters in predicting long-term outcome. In a randomized clinical trial with 409 individuals experiencing mild to moderate depressive symptoms using the web-based intervention deprexis, three latent classes were identified (early response after registration, early response after screening and early deterioration) based on early change in the first four weeks of the intervention. Baseline variables and these classes were included in a Stepwise Cox Proportional Hazard Multiple Regression to identify predictors associated with the onset of remission over 36-months. Early change class was a significant predictor of remission over 36 months. Compared to early deterioration after screening, both early response after registration and after screening were associated with a higher likelihood of remission. In sensitivity and secondary analyses, only change class consistently emerged as a predictor of long-term outcome. Early improvement in depression symptoms predicted long-term outcome and those showing early improvement had a higher likelihood of long-term remission. These findings suggest that early changes might be a robust predictor for long-term outcome beyond baseline parameters.
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Affiliation(s)
- Susanne Edelbluth
- Department of Clinical Psychology and Psychotherapy, University of Trier, Trier, Germany
| | - Jan Philipp Klein
- Department of Psychiatry and Psychotherapy, Lübeck University, Lübeck, Germany
| | - Brian Schwartz
- Department of Clinical Psychology and Psychotherapy, University of Trier, Trier, Germany
| | - Miriam Hehlmann
- Department of Clinical Psychology and Psychotherapy for Adults, Osnabrueck University, Osnabrueck, Germany
| | - Alice Arndt
- Department of Clinical Psychology and Psychotherapy, University of Trier, Trier, Germany
| | - Julian Rubel
- Department of Clinical Psychology and Psychotherapy for Adults, Osnabrueck University, Osnabrueck, Germany
| | - Danilo Moggia
- Department of Clinical Psychology and Psychotherapy, University of Trier, Trier, Germany
| | - Thomas Berger
- Department of Psychology, Bern University, Bern, Switzerland
| | | | - Steffen Moritz
- Department of Psychiatry and Psychotherapy, University Medical Center Hamburg Eppendorf, Hamburg, Germany
| | - Johanna Schröder
- Department of Psychology, MSH Medical School Hamburg, Institute of Clinical Psychology and Psychotherapy, Hamburg, Germany
| | - Wolfgang Lutz
- Department of Clinical Psychology and Psychotherapy, University of Trier, Trier, Germany
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10
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Lau CKY, Saad A, Camara B, Rahman D, Bolea-Alamanac B. Acceptability of Digital Mental Health Interventions for Depression and Anxiety: Systematic Review. J Med Internet Res 2024; 26:e52609. [PMID: 39466300 PMCID: PMC11555460 DOI: 10.2196/52609] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/09/2023] [Revised: 02/27/2024] [Accepted: 04/30/2024] [Indexed: 10/29/2024] Open
Abstract
BACKGROUND Depression and anxiety disorders are common, and treatment often includes psychological interventions. Digital health interventions, delivered through technologies such as web-based programs and mobile apps, are increasingly used in mental health treatment. Acceptability, the extent to which an intervention is viewed positively, has been identified as contributing to patient adherence and engagement with digital health interventions. Acceptability, therefore, impacts the benefit derived from using digital health interventions in treatment. Understanding the acceptability of digital mental health interventions among patients with depression or anxiety disorders is essential to maximize the effectiveness of their treatment. OBJECTIVE This review investigated the acceptability of technology-based interventions among patients with depression or anxiety disorders. METHODS A systematic review was performed based on PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) and PROSPERO (International Prospective Register of Systematic Reviews) guidelines. We searched PubMed, Web of Science, and Ovid in May 2022. Studies were included if they evaluated digital interventions for the treatment of depression or anxiety disorders and investigated their acceptability among adult patients. Studies were excluded if they targeted only specific populations (eg, those with specific physical health conditions), investigated acceptability in healthy individuals or patients under the age of 18 years, involved no direct interaction between patients and technologies, used technology only as a platform for traditional care (eg, videoconferencing), had patients using technologies only in clinical or laboratory settings, or involved virtual reality technologies. Acceptability outcome data were narratively synthesized by the direction of acceptability using vote counting. Included studies were evaluated using levels of evidence from the Oxford Centre for Evidence-Based Medicine. The risk of bias was assessed using a tool designed for this review and GRADE (Grading of Recommendations, Assessment, Development, and Evaluation). RESULTS A total of 143 articles met the inclusion criteria, comprising 67 (47%) articles on interventions for depression, 65 (45%) articles on interventions for anxiety disorders, and 11 (8%) articles on interventions for both. Overall, 90 (63%) were randomized controlled trials, 50 (35%) were other quantitative studies, and 3 (2%) were qualitative studies. Interventions used web-based programs, mobile apps, and computer programs. Cognitive behavioral therapy was the basis of 71% (102/143) of the interventions. Digital mental health interventions were generally acceptable among patients with depression or anxiety disorders, with 88% (126/143) indicating positive acceptability, 8% (11/143) mixed results, and 4% (6/143) insufficient information to categorize the direction of acceptability. The available research evidence was of moderate quality. CONCLUSIONS Digital mental health interventions seem to be acceptable to patients with depression or anxiety disorders. Consistent use of validated measures for acceptability would enhance the quality of evidence. Careful design of acceptability as an evaluation outcome can further improve the quality of evidence and reduce the risk of bias. TRIAL REGISTRATION Open Science Framework Y7MJ4; https://doi.org/10.17605/OSF.IO/SPR8M.
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Affiliation(s)
- Carrie K Y Lau
- Department of Psychiatry, Women's College Hospital, Toronto, ON, Canada
- Factor-Inwentash Faculty of Social Work, University of Toronto, Toronto, ON, Canada
| | - Anthony Saad
- Department of Psychiatry, Women's College Hospital, Toronto, ON, Canada
| | - Bettina Camara
- Department of Immunology, Faculty of Medicine, University of Toronto, Toronto, ON, Canada
| | | | - Blanca Bolea-Alamanac
- Department of Psychiatry, Women's College Hospital, Toronto, ON, Canada
- Department of Psychiatry, University of Toronto, Toronto, ON, Canada
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Pearson R, Beevers CG, Mignogna J, Benzer J, Pfeiffer PN, Post E, Creech SK. The Evaluation of a Web-Based Intervention (Deprexis) to Decrease Depression and Restore Functioning in Veterans: Protocol for a Randomized Controlled Trial. JMIR Res Protoc 2024; 13:e59119. [PMID: 39446432 PMCID: PMC11544330 DOI: 10.2196/59119] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/23/2024] [Revised: 06/22/2024] [Accepted: 06/24/2024] [Indexed: 10/26/2024] Open
Abstract
BACKGROUND Depressive symptoms are common in veterans, and the presence of these symptoms increases disability as well as suicidal thoughts and behaviors. However, there is evidence that these symptoms often go untreated. Intervening before symptoms become severe and entrenched is related to better long-term outcomes, including improved functioning and less disease chronicity. Computer-delivered interventions may be especially appropriate for those veterans with mild to moderate depressive symptoms, because these interventions can require fewer resources and have lower barriers to access and thus have potential for wider reach. Despite this potential, there is a dearth of research examining computerized interventions for depressive symptoms in veteran samples. OBJECTIVE The aim of this study is to evaluate the efficacy of Deprexis (GAIA AG), a computerized intervention for depressive symptoms and related functional impairment. METHODS Veterans will be recruited through the US Department of Veterans Affairs electronic medical record and through primary care and specialty clinics. First, qualitative interviews will be completed with a small subset of veterans (n=16-20) to assess the acceptability of treatment procedures. Next, veterans (n=132) with mild to moderate depressive symptoms will be randomly assigned to the fully automated Deprexis intervention or a treatment-as-usual control group. The primary outcomes will be self-reported depressive symptoms and various dimensions of psychosocial functioning. RESULTS This project was funded in May 2024, and data collection will be conducted between October 2024 and April 2029. Overall, 4 participants have been recruited as of the submission of the manuscript, and data analysis is expected in June 2029, with initial results expected in November 2029. CONCLUSIONS This study will provide initial evidence for the efficacy of self-guided, computerized interventions for depressive symptoms and functional impairment in veterans. If effective, these types of interventions could improve veteran access to low-resource psychosocial treatments. TRIAL REGISTRATION ClinicalTrials.gov NCT06217198; https://www.clinicaltrials.gov/study/NCT06217198. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID) PRR1-10.2196/59119.
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Affiliation(s)
- Rahel Pearson
- Veterans Integrated Service Network 17 Center of Excellence for Research on Returning War Veterans, Central Texas Veterans Affairs Healthcare System, Waco, TX, United States
| | - Christopher G Beevers
- Department of Psychology and Institute for Mental Health Research, University of Texas at Austin, Austin, TX, United States
| | - Joseph Mignogna
- Rocky Mountain Mental Illness, Research, Education and Clinical Center for Suicide Prevention, Rocky Mountain Regional VHA Medical Center, Aurora, CO, United States
- Department of Physical Medicine and Rehabilitation, University of Colorado Anschutz Medical Campus, Aurora, CO, United States
| | - Justin Benzer
- Veterans Integrated Service Network 17 Center of Excellence for Research on Returning War Veterans, Central Texas Veterans Affairs Healthcare System, Waco, TX, United States
- Department of Psychiatry and Behavioral Sciences, Dell Medical School, University of Texas at Austin, Austin, TX, United States
| | - Paul N Pfeiffer
- Veterans Affairs Ann Arbor Healthcare System, Ann Arbor, MI, United States
- Department of Psychiatry, University of Michigan Medical School, Ann Arbor, MI, United States
| | - Edward Post
- Veterans Affairs Ann Arbor Healthcare System, Ann Arbor, MI, United States
- Department of Psychiatry, University of Michigan Medical School, Ann Arbor, MI, United States
| | - Suzannah K Creech
- Veterans Integrated Service Network 17 Center of Excellence for Research on Returning War Veterans, Central Texas Veterans Affairs Healthcare System, Waco, TX, United States
- Department of Psychiatry and Behavioral Sciences, Dell Medical School, University of Texas at Austin, Austin, TX, United States
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12
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Brown J, Cox L, Mulligan K, Wilson S, Heys M, Livermore P, Gray S, Bogosian A. Gaining consensus on emotional wellbeing themes and preferences for digital intervention type and content to support the mental health of young people with long-term health conditions: A Delphi study. Health Expect 2024; 27:e14025. [PMID: 38591848 PMCID: PMC11003273 DOI: 10.1111/hex.14025] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/03/2023] [Revised: 02/21/2024] [Accepted: 03/07/2024] [Indexed: 04/10/2024] Open
Abstract
BACKGROUND Young people (YP) with long-term conditions (LTCs) are at greater risk of psychological distress than those without LTCs. Despite this, there is a scarcity of quality digital interventions designed to help improve mental wellbeing in this population. The aim of this study was to determine what YP, parents and health professionals preferred for future interventions. METHODS Twenty-six YP with asthma, diabetes and/or epilepsy (the three most common LTCs in YP), 23 parents of YP with LTCs and 10 health professionals mainly in paediatric specialisms (total n = 59) took part in an online Delphi study to gain consensus (set at 75% agreement) on four questions across three rounds. Participants ordered psychological themes that may be experienced by YP with LTCs by importance and ranked digital intervention types and delivery modes by importance or usefulness. The most common results were reported if no consensus was reached by round 3. RESULTS Participants preferred a mobile phone app (73% agreement) and a mixture of one-on-one and group support for an intervention (75% agreement). The two highest ranked psychological themes were anxiety (44%) and wanting to appear 'normal' (38%), and the top intervention type was 'general counselling' (54% agreement). CONCLUSION There was a clear desire for an app to help with the psychological aspects of living with LTCs and for a combination of one-to-one and group intervention elements. Anxiety and wanting to appear 'normal' might be two closely linked psychological challenges that could be addressed by a single intervention. IMPLICATIONS The results will be important to consider for a future intervention, although further consultation will be needed for app development. PATIENT OR PUBLIC CONTRIBUTION Two YP with a LTC provided feedback on the study protocol including the aims and procedures of the project. Another six YP with LTCs were consulted on an early draft of the study questionnaire (the four questions), which was subsequently revised. Once the project began, a patient and public involvement group consisting of two YP with LTCs and one parent of a YP with an LTC gave feedback on the research process, lay report of the results and dissemination plan.
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Affiliation(s)
- Jennie Brown
- School of Health and Psychological SciencesCity University of LondonLondonUK
| | - Lauren Cox
- School of Health and Psychological SciencesCity University of LondonLondonUK
| | - Kathleen Mulligan
- School of Health and Psychological SciencesCity University of LondonLondonUK
| | - Stephanie Wilson
- School of Mathematics, Computer Science and EngineeringCity University of LondonLondonUK
| | - Michelle Heys
- East London NHS Foundation TrustLondonUK
- Population, Policy and Practice DepartmentUniversity College LondonLondonUK
| | - Polly Livermore
- Great Ormond Street Institute of Child Health (GOS ICH)LondonUK
| | - Suzy Gray
- Great Ormond Street Institute of Child Health (GOS ICH)LondonUK
| | - Angeliki Bogosian
- School of Health and Psychological SciencesCity University of LondonLondonUK
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13
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Haaf R, Vock P, Wächtershäuser N, Correll CU, Köhler S, Klein JP. [Efficacy of internet-based interventions for depression available in Germany-A systematic review and meta-analysis]. DER NERVENARZT 2024; 95:206-215. [PMID: 38260995 PMCID: PMC10914865 DOI: 10.1007/s00115-023-01587-0] [Citation(s) in RCA: 1] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Subscribe] [Scholar Register] [Accepted: 11/27/2023] [Indexed: 01/24/2024]
Abstract
BACKGROUND Internet-based interventions (IBIs) for the treatment of depression have been found to have positive effects in international meta-analyses; however, it is unclear whether these effects also extend to IBIs specifically available in Germany. The aim of this meta-analysis was to estimate the immediate effects and the long-term effects of IBIs available in Germany free of charge or available on prescription and covered by the public health insurances as so-called digital health applications (DiGAs) and to compare the efficacy of DiGAs and freely available IBIs. METHOD A systematic literature search and random-effects meta-analysis were performed (preregistration: INPLASY202250070). Randomized controlled trials (RCTs) of IBIs freely available in Germany or as DiGA in adults with elevated depressive symptoms were compared with active and inactive controls available at the time of the survey in May 2022. RESULTS A total of six interventions were identified: COGITO, deprexis, iFightDepression, moodgym, Novego, and Selfapy. The pooled effect size of a total of 28 studies with 13,413 participants corresponded to an effect of Cohen's d = 0.42, (95% confidence interval, CI: 0.31-0.54, I2 = 81%). The analysis of long-term effects showed a smaller effect size of d = 0.29, (95% CI: 0.21-0.37, I2 = 22%, N = 10). Subgroup analyses indicated a possible superiority of the three interventions listed in the DiGA directory (d = 0.56, 95% CI: 0.38-0.74, I2 = 83%, N = 15) compared to the three freely available IBIs (d = 0.24, 95% CI: 0.14-0.33, I2 = 44%, N = 13, p = 0.002). CONCLUSION The IBIs for depressive disorders available in Germany are effective and can therefore be used in the treatment of people with a depressive disorder; however, it is possible that not all interventions are equally effective.
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Affiliation(s)
- Raoul Haaf
- Klinik für Psychiatrie und Psychotherapie, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Campus Charité Mitte, Berlin, Deutschland.
| | - Pia Vock
- Klinik für Psychiatrie, Psychosomatik und Psychotherapie, Universität zu Lübeck, Lübeck, Deutschland
| | - Nikolaj Wächtershäuser
- Klinik für Psychiatrie, Psychosomatik und Psychotherapie, Universität zu Lübeck, Lübeck, Deutschland
| | - Christoph U Correll
- Klinik für Kinder- und Jugendpsychiatrie, Charité - Universitätsmedizin Berlin, Berlin, Deutschland
- Department of Psychiatry, The Zucker Hillside Hospital, Northwell Health, Glen Oaks, NY, USA
- Department of Psychiatry and Molecular Medicine, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, NY, USA
| | - Stephan Köhler
- Klinik für Psychiatrie und Psychotherapie, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Campus Charité Mitte, Berlin, Deutschland
| | - Jan Philipp Klein
- Klinik für Psychiatrie, Psychosomatik und Psychotherapie, Universität zu Lübeck, Lübeck, Deutschland
- Center for Brain, Behavior and Metabolism, Universität zu Lübeck, Lübeck, Deutschland
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14
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Jabir AI, Lin X, Martinengo L, Sharp G, Theng YL, Tudor Car L. Attrition in Conversational Agent-Delivered Mental Health Interventions: Systematic Review and Meta-Analysis. J Med Internet Res 2024; 26:e48168. [PMID: 38412023 PMCID: PMC10933752 DOI: 10.2196/48168] [Citation(s) in RCA: 5] [Impact Index Per Article: 5.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/25/2023] [Revised: 09/21/2023] [Accepted: 12/04/2023] [Indexed: 02/28/2024] Open
Abstract
BACKGROUND Conversational agents (CAs) or chatbots are computer programs that mimic human conversation. They have the potential to improve access to mental health interventions through automated, scalable, and personalized delivery of psychotherapeutic content. However, digital health interventions, including those delivered by CAs, often have high attrition rates. Identifying the factors associated with attrition is critical to improving future clinical trials. OBJECTIVE This review aims to estimate the overall and differential rates of attrition in CA-delivered mental health interventions (CA interventions), evaluate the impact of study design and intervention-related aspects on attrition, and describe study design features aimed at reducing or mitigating study attrition. METHODS We searched PubMed, Embase (Ovid), PsycINFO (Ovid), Cochrane Central Register of Controlled Trials, and Web of Science, and conducted a gray literature search on Google Scholar in June 2022. We included randomized controlled trials that compared CA interventions against control groups and excluded studies that lasted for 1 session only and used Wizard of Oz interventions. We also assessed the risk of bias in the included studies using the Cochrane Risk of Bias Tool 2.0. Random-effects proportional meta-analysis was applied to calculate the pooled dropout rates in the intervention groups. Random-effects meta-analysis was used to compare the attrition rate in the intervention groups with that in the control groups. We used a narrative review to summarize the findings. RESULTS The systematic search retrieved 4566 records from peer-reviewed databases and citation searches, of which 41 (0.90%) randomized controlled trials met the inclusion criteria. The meta-analytic overall attrition rate in the intervention group was 21.84% (95% CI 16.74%-27.36%; I2=94%). Short-term studies that lasted ≤8 weeks showed a lower attrition rate (18.05%, 95% CI 9.91%- 27.76%; I2=94.6%) than long-term studies that lasted >8 weeks (26.59%, 95% CI 20.09%-33.63%; I2=93.89%). Intervention group participants were more likely to attrit than control group participants for short-term (log odds ratio 1.22, 95% CI 0.99-1.50; I2=21.89%) and long-term studies (log odds ratio 1.33, 95% CI 1.08-1.65; I2=49.43%). Intervention-related characteristics associated with higher attrition include stand-alone CA interventions without human support, not having a symptom tracker feature, no visual representation of the CA, and comparing CA interventions with waitlist controls. No participant-level factor reliably predicted attrition. CONCLUSIONS Our results indicated that approximately one-fifth of the participants will drop out from CA interventions in short-term studies. High heterogeneities made it difficult to generalize the findings. Our results suggested that future CA interventions should adopt a blended design with human support, use symptom tracking, compare CA intervention groups against active controls rather than waitlist controls, and include a visual representation of the CA to reduce the attrition rate. TRIAL REGISTRATION PROSPERO International Prospective Register of Systematic Reviews CRD42022341415; https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42022341415.
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Affiliation(s)
- Ahmad Ishqi Jabir
- Lee Kong Chian School of Medicine, Nanyang Technological University Singapore, Singapore, Singapore
- Future Health Technologies, Singapore-ETH Centre, Campus for Research Excellence And Technological Enterprise, Singapore, Singapore
| | - Xiaowen Lin
- Lee Kong Chian School of Medicine, Nanyang Technological University Singapore, Singapore, Singapore
| | - Laura Martinengo
- Lee Kong Chian School of Medicine, Nanyang Technological University Singapore, Singapore, Singapore
| | - Gemma Sharp
- Department of Neuroscience, Monash University, Melbourne, Australia
| | - Yin-Leng Theng
- Centre for Healthy and Sustainable Cities, Wee Kim Wee School of Communication and Information, Nanyang Technological University Singapore, Singapore, Singapore
| | - Lorainne Tudor Car
- Lee Kong Chian School of Medicine, Nanyang Technological University Singapore, Singapore, Singapore
- Department of Primary Care and Public Health, School of Public Health, Imperial College London, London, United Kingdom
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15
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Biskupiak Z, Ha VV, Rohaj A, Bulaj G. Digital Therapeutics for Improving Effectiveness of Pharmaceutical Drugs and Biological Products: Preclinical and Clinical Studies Supporting Development of Drug + Digital Combination Therapies for Chronic Diseases. J Clin Med 2024; 13:403. [PMID: 38256537 PMCID: PMC10816409 DOI: 10.3390/jcm13020403] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/30/2023] [Revised: 01/08/2024] [Accepted: 01/09/2024] [Indexed: 01/24/2024] Open
Abstract
Limitations of pharmaceutical drugs and biologics for chronic diseases (e.g., medication non-adherence, adverse effects, toxicity, or inadequate efficacy) can be mitigated by mobile medical apps, known as digital therapeutics (DTx). Authorization of adjunct DTx by the US Food and Drug Administration and draft guidelines on "prescription drug use-related software" illustrate opportunities to create drug + digital combination therapies, ultimately leading towards drug-device combination products (DTx has a status of medical devices). Digital interventions (mobile, web-based, virtual reality, and video game applications) demonstrate clinically meaningful benefits for people living with Alzheimer's disease, dementia, rheumatoid arthritis, cancer, chronic pain, epilepsy, depression, and anxiety. In the respective animal disease models, preclinical studies on environmental enrichment and other non-pharmacological modalities (physical activity, social interactions, learning, and music) as surrogates for DTx "active ingredients" also show improved outcomes. In this narrative review, we discuss how drug + digital combination therapies can impact translational research, drug discovery and development, generic drug repurposing, and gene therapies. Market-driven incentives to create drug-device combination products are illustrated by Humira® (adalimumab) facing a "patent-cliff" competition with cheaper and more effective biosimilars seamlessly integrated with DTx. In conclusion, pharma and biotech companies, patients, and healthcare professionals will benefit from accelerating integration of digital interventions with pharmacotherapies.
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Affiliation(s)
- Zack Biskupiak
- Department of Medicinal Chemistry, College of Pharmacy, University of Utah, Salt Lake City, UT 84112, USA
| | - Victor Vinh Ha
- Department of Medicinal Chemistry, College of Pharmacy, University of Utah, Salt Lake City, UT 84112, USA
| | - Aarushi Rohaj
- Department of Medicinal Chemistry, College of Pharmacy, University of Utah, Salt Lake City, UT 84112, USA
- The Spencer Fox Eccles School of Medicine, University of Utah, Salt Lake City, UT 84113, USA
| | - Grzegorz Bulaj
- Department of Medicinal Chemistry, College of Pharmacy, University of Utah, Salt Lake City, UT 84112, USA
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Guest PC, Vasilevska V, Al-Hamadi A, Eder J, Falkai P, Steiner J. Digital technology and mental health during the COVID-19 pandemic: a narrative review with a focus on depression, anxiety, stress, and trauma. Front Psychiatry 2023; 14:1227426. [PMID: 38188049 PMCID: PMC10766703 DOI: 10.3389/fpsyt.2023.1227426] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/26/2023] [Accepted: 12/11/2023] [Indexed: 01/09/2024] Open
Abstract
The sudden appearance and devastating effects of the COVID-19 pandemic resulted in the need for multiple adaptive changes in societies, business operations and healthcare systems across the world. This review describes the development and increased use of digital technologies such as chat bots, electronic diaries, online questionnaires and even video gameplay to maintain effective treatment standards for individuals with mental health conditions such as depression, anxiety and post-traumatic stress syndrome. We describe how these approaches have been applied to help meet the challenges of the pandemic in delivering mental healthcare solutions. The main focus of this narrative review is on describing how these digital platforms have been used in diagnostics, patient monitoring and as a treatment option for the general public, as well as for frontline medical staff suffering with mental health issues.
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Affiliation(s)
- Paul C. Guest
- Department of Psychiatry, Otto-von-Guericke-University Magdeburg, Magdeburg, Germany
- Laboratory of Translational Psychiatry, Otto-von-Guericke-University Magdeburg, Magdeburg, Germany
- Laboratory of Neuroproteomics, Department of Biochemistry and Tissue Biology, Institute of Biology University of Campinas (UNICAMP), Campinas, Brazil
| | - Veronika Vasilevska
- Department of Psychiatry, Otto-von-Guericke-University Magdeburg, Magdeburg, Germany
- Laboratory of Translational Psychiatry, Otto-von-Guericke-University Magdeburg, Magdeburg, Germany
| | - Ayoub Al-Hamadi
- Department of Neuro-Information Technology, Institute for Information Technology and Communications Otto-von-Guericke University Magdeburg, Magdeburg, Germany
| | - Julia Eder
- Department of Psychiatry and Psychotherapy, University Hospital Ludwig-Maximilians-University Munich, Munich, Germany
| | - Peter Falkai
- Department of Psychiatry and Psychotherapy, University Hospital Ludwig-Maximilians-University Munich, Munich, Germany
| | - Johann Steiner
- Department of Psychiatry, Otto-von-Guericke-University Magdeburg, Magdeburg, Germany
- Laboratory of Translational Psychiatry, Otto-von-Guericke-University Magdeburg, Magdeburg, Germany
- Center for Health and Medical Prevention (CHaMP), Magdeburg, Germany
- German Center for Mental Health (DZPG), Center for Intervention and Research on Adaptive and Maladaptive Brain Circuits Underlying Mental Health (C-I-R-C), Halle-Jena-Magdeburg, Magdeburg, Germany
- Center for Behavioral Brain Sciences (CBBS), Magdeburg, Germany
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Schreiter S, Mascarell-Maricic L, Rakitzis O, Volkmann C, Kaminski J, Daniels MA. Digital Health Applications in the Area of Mental Health. DEUTSCHES ARZTEBLATT INTERNATIONAL 2023; 120:797-803. [PMID: 37732500 PMCID: PMC10777310 DOI: 10.3238/arztebl.m2023.0208] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Received: 03/09/2023] [Revised: 09/06/2023] [Accepted: 09/06/2023] [Indexed: 09/22/2023]
Abstract
BACKGROUND The introduction of digital health applications (DiGA) is a fundamental innovation in Germany. In the field of mental health, numerous applications are already available whose efficacy has been tested in clinical trials. We investigated whether, and to what extent, the use of DiGA can be recommended on the basis of the available evidence. METHODS In this scoping review, we summarize the evidence supporting the use of DiGA in the mental health field through an examination of relevant publications that were retrieved by a systematic literature search. We provide an annotated tabular listing and discuss the current advantages of, and obstacles to, the care of mentally ill patients with the aid of DiGA. RESULTS We identified 17 DiGA for use in depression, anxiety disorders, addiction disorders, sleep disorders, stress/burnout, vaginismus, and chronic pain. These DiGA have been evaluated to date in 3 meta-analyses, 39 randomized controlled trials (RCTs), and two single-armed intervention trials. 23 of the 36 published trials were carried out with the direct participation of the manufacturers. 29 of the 39 RCTs were not blinded or contained no information regarding blinding. Active controls were used in 6 of the 39 RCTs. The reported effect sizes, with the exclusion of pre-post analyses, ranged from 0.16 to 1.79. CONCLUSION Most of the published studies display a high risk of bias, both because of the manufacturers' participation and because of methodological deficiencies. DiGA are an increasingly important therapeutic modality in psychiatry. The available evidence indicates that treatment effects are indeed present, but prospective comparisons with established treatments are still entirely lacking.
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Affiliation(s)
- Stefanie Schreiter
- Department of Psychiatry and Neurosciences, CCM, Charité – Universitätsmedizin Berlin, Berlin, Germany
| | - Lea Mascarell-Maricic
- Department of Psychiatry and Neurosciences, CCM, Charité – Universitätsmedizin Berlin, Berlin, Germany
| | - Orestis Rakitzis
- Department of Psychiatry and Neurosciences, CCM, Charité – Universitätsmedizin Berlin, Berlin, Germany
| | - Constantin Volkmann
- Department of Psychiatry and Neurosciences, CCM, Charité – Universitätsmedizin Berlin, Berlin, Germany
| | - Jakob Kaminski
- * These authors share last authorship
- Department of Psychiatry and Neurosciences, CCM, Charité – Universitätsmedizin Berlin, Berlin, Germany
| | - Martin André Daniels
- * These authors share last authorship
- Department of Psychiatry and Neurosciences, CCM, Charité – Universitätsmedizin Berlin, Berlin, Germany
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Gutierrez G, Gizzarelli T, Moghimi E, Vazquez G, Alavi N. Online cognitive behavioral therapy (eCBT) for the management of depression symptoms in unipolar and bipolar spectrum disorders, a systematic review and network meta-analysis. J Affect Disord 2023; 341:379-392. [PMID: 37683940 DOI: 10.1016/j.jad.2023.09.005] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/21/2022] [Revised: 07/30/2023] [Accepted: 09/05/2023] [Indexed: 09/10/2023]
Abstract
BACKGROUND Face-to-face cognitive behavioral therapy (CBT) is effective in the management of depression symptoms in unipolar and bipolar spectrum disorders. Though, compared to electronic adaptations of CBT (eCBT), it carries several accessibility limitations. Furthermore, unlike eCBT for depression symptoms (eCBTg), eCBT specific for bipolar depression (eCBT-Bipol) remains largely understudied. Thus, supplementing this gap, this systematic review and network meta-analysis (NMA) synthesized the available literature on eCBT for the treatment of unipolar and bipolar depression symptoms. METHOD MEDLINE, CINAHL, PsycINFO, EMBASE, and Cochrane were searched for relevant randomized controlled trials (RCTs) on eCBTg and eCBT-Bipol The review followed PRISMA guidelines and used the Cochrane risk of bias tool and GRADE criteria for quality assessment. Effect sizes were summarized using standardized mean differences (SMDs) and risk ratios (RRs). RESULTS eCBT-Bipol was comparable to eCBTg (SMD: 0.05, 95 % CI: -0.18; 0.28) and other psychotherapeutic interventions (SMD: 0.14, 95 % CI: -0.07; 0.35) for the management of mild to moderate depression symptoms. eCBT-Bipol was significantly more effective than attention controls (SMD: 0.35, 95 % CI: 0.11; 0.59), treatment as usual (SMD: 0.55, 95 % CI: 0.21; 0.90) and no intervention controls (SMD: 0.66, 95 % CI: 0.40; 0.93) in mitigating symptoms. LIMITATIONS The scarcity of eCBT-Bipol studies impacted the quality of the evidence in terms of risk of bias and imprecision. CONCLUSIONS The findings of this systematic review suggest that eCBT-Bipol has comparable effectiveness to eCBTg in managing depressive symptoms of unipolar and bipolar spectrum disorder. Though, they also highlighted the need for more studies on eCBT-Bipol.
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Affiliation(s)
- Gilmar Gutierrez
- Department of Psychiatry, Faculty of Health Sciences, Queen's University, Kingston, Ontario, Canada.
| | - Tessa Gizzarelli
- Department of Psychiatry, Faculty of Health Sciences, Queen's University, Kingston, Ontario, Canada
| | - Elnaz Moghimi
- Department of Psychiatry, Faculty of Health Sciences, Queen's University, Kingston, Ontario, Canada
| | - Gustavo Vazquez
- Department of Psychiatry, Faculty of Health Sciences, Queen's University, Kingston, Ontario, Canada
| | - Nazanin Alavi
- Department of Psychiatry, Faculty of Health Sciences, Queen's University, Kingston, Ontario, Canada; Centre for Neuroscience Studies, Faculty of Health Sciences, Queen's University, Kingston, Ontario, Canada; OPTT Inc., Toronto, Ontario, Canada
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19
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Gold SM, Friede T, Meyer B, Moss-Morris R, Hudson J, Asseyer S, Bellmann-Strobl J, Leisdon A, Ißels L, Ritter K, Schymainski D, Pomeroy H, Lynch SG, Cozart JS, Thelen J, Román CAF, Cadden M, Guty E, Lau S, Pöttgen J, Ramien C, Seddiq-Zai S, Kloidt AM, Wieditz J, Penner IK, Paul F, Sicotte NL, Bruce JM, Arnett PA, Heesen C. Internet-delivered cognitive behavioural therapy programme to reduce depressive symptoms in patients with multiple sclerosis: a multicentre, randomised, controlled, phase 3 trial. Lancet Digit Health 2023; 5:e668-e678. [PMID: 37775187 PMCID: PMC10921847 DOI: 10.1016/s2589-7500(23)00109-7] [Citation(s) in RCA: 17] [Impact Index Per Article: 8.5] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/12/2022] [Revised: 05/23/2023] [Accepted: 05/25/2023] [Indexed: 10/01/2023]
Abstract
BACKGROUND Depression is three to four times more prevalent in patients with neurological and inflammatory disorders than in the general population. For example, in patients with multiple sclerosis, the 12-month prevalence of major depressive disorder is around 25% and it is associated with a lower quality of life, faster disease progression, and higher morbidity and mortality. Despite its clinical relevance, there are few treatment options for depression associated with multiple sclerosis and confirmatory trials are scarce. We aimed to evaluate the safety and efficacy of a multiple sclerosis-specific, internet-based cognitive behavioural therapy (iCBT) programme for the treatment of depressive symptoms associated with the disease. METHODS This parallel-group, randomised, controlled, phase 3 trial of an iCBT programme to reduce depressive symptoms in patients with multiple sclerosis was carried out at five academic centres with large outpatient care units in Germany and the USA. Patients with a neurologist-confirmed diagnosis of multiple sclerosis and depressive symptoms were randomly assigned (1:1:1; automated assignment, concealed allocation, no stratification, no blocking) to receive treatment as usual plus one of two versions of the iCBT programme Amiria (stand-alone or therapist-guided) or to a control condition, in which participants received treatment as usual and were offered access to the iCBT programme after 6 months. Masking of participants to group assignment between active treatment and control was not possible, although raters were masked to group assignment. The predefined primary endpoint, which was analysed in the intention-to-treat population, was severity of depressive symptoms as measured by the Beck Depression Inventory-II (BDI-II) at week 12 after randomisation. This trial is registered at ClinicalTrials.gov, NCT02740361, and is complete. FINDINGS Between May 3, 2017, and Nov 4, 2020, we screened 485 patients for eligibility. 279 participants were enrolled, of whom 101 were allocated to receive stand-alone iCBT, 85 to receive guided iCBT, and 93 to the control condition. The dropout rate at week 12 was 18% (50 participants). Both versions of the iCBT programme significantly reduced depressive symptoms compared with the control group (BDI-II between-group mean differences: control vs stand-alone iCBT 6·32 points [95% CI 3·37-9·27], p<0·0001, effect size d=0·97 [95% CI 0·64-1·30]; control vs guided iCBT 5·80 points [2·71-8·88], p<0·0001, effect size d=0·96 [0·62-1·30]). Clinically relevant worsening of depressive symptoms was observed in three participants in the control group, one in the stand-alone iCBT group, and none in the guided iCBT group. No occurrences of suicidality were observed during the trial and there were no deaths. INTERPRETATION This trial provides evidence for the safety and efficacy of a multiple sclerosis-specific iCBT tool to reduce depressive symptoms in patients with the disease. This remote-access, scalable intervention increases the therapeutic options in this patient group and could help to overcome treatment barriers. FUNDING National Multiple Sclerosis Society (USA).
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Affiliation(s)
- Stefan M Gold
- Klinik für Psychiatrie und Psychotherapie, Campus Benjamin Franklin, Charité-Universitätsmedizin Berlin, Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany; Medizinische Klinik mS Psychosomatik, Charité-Universitätsmedizin Berlin, Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany; German Center for Mental Health (DZPG), Berlin, Germany; Institut für Neuroimmunologie und Multiple Sklerose, Universitätklinikum Hamburg-Eppendorf, Hamburg, Germany.
| | - Tim Friede
- Department of Medical Statistics, University Medical Center Göttingen, Göttingen, Germany
| | - Björn Meyer
- Research Department, GAIA AG, Hamburg, Germany
| | - Rona Moss-Morris
- Psychology Department, Institute of Psychiatry, Psychology, and Neuroscience, King's College London, London, UK
| | - Joanna Hudson
- Psychology Department, Institute of Psychiatry, Psychology, and Neuroscience, King's College London, London, UK
| | - Susanna Asseyer
- NeuroCure Clinical Research Center, Charité-Universitätsmedizin Berlin, Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany
| | - Judith Bellmann-Strobl
- NeuroCure Clinical Research Center, Charité-Universitätsmedizin Berlin, Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany; Experimental and Clinical Research Center, Max Delbrück Center for Molecular Medicine and Charité-Universitätsmedizin Berlin, Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany
| | - Andreas Leisdon
- Klinik für Psychiatrie und Psychotherapie, Campus Benjamin Franklin, Charité-Universitätsmedizin Berlin, Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany
| | - Leonie Ißels
- Klinik für Psychiatrie und Psychotherapie, Campus Benjamin Franklin, Charité-Universitätsmedizin Berlin, Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany
| | - Kristin Ritter
- Klinik für Psychiatrie und Psychotherapie, Campus Benjamin Franklin, Charité-Universitätsmedizin Berlin, Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany
| | - David Schymainski
- Klinik für Psychiatrie und Psychotherapie, Campus Benjamin Franklin, Charité-Universitätsmedizin Berlin, Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany
| | - Hayley Pomeroy
- Department of Neurology, Cedars Sinai Medical Center, Los Angeles, CA, USA
| | - Sharon G Lynch
- Department of Neurology, University of Kansas School of Medicine, Kansas City, KS, USA
| | - Julia S Cozart
- Department of Psychology, University of Missouri-Kansas City, Kansas City, MO, USA
| | - Joan Thelen
- Department of Psychology, University of Missouri-Kansas City, Kansas City, MO, USA
| | - Cristina A F Román
- Kessler Foundation, Rutgers New Jersey Medical School, Newark, NJ, USA; Department of Physical Medicine & Rehabilitation, Rutgers New Jersey Medical School, Newark, NJ, USA; Department of Neurology, Rutgers New Jersey Medical School, Newark, NJ, USA
| | - Margaret Cadden
- Harvard Medical School, Massachusetts General Hospital/Brigham and Women's Hospital, Boston, MA, USA
| | - Erin Guty
- Department of Psychology, Penn State University, University Park, PA, USA
| | - Stephanie Lau
- Institut für Neuroimmunologie und Multiple Sklerose, Universitätklinikum Hamburg-Eppendorf, Hamburg, Germany
| | - Jana Pöttgen
- Institut für Neuroimmunologie und Multiple Sklerose, Universitätklinikum Hamburg-Eppendorf, Hamburg, Germany
| | - Caren Ramien
- Institut für Neuroimmunologie und Multiple Sklerose, Universitätklinikum Hamburg-Eppendorf, Hamburg, Germany
| | - Susan Seddiq-Zai
- Institut für Neuroimmunologie und Multiple Sklerose, Universitätklinikum Hamburg-Eppendorf, Hamburg, Germany
| | - Anna-Maria Kloidt
- Department of Medical Statistics, University Medical Center Göttingen, Göttingen, Germany
| | - Johannes Wieditz
- Department of Medical Statistics, University Medical Center Göttingen, Göttingen, Germany
| | - Iris-Katharina Penner
- Department of Neurology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland
| | - Friedemann Paul
- NeuroCure Clinical Research Center, Charité-Universitätsmedizin Berlin, Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany; Experimental and Clinical Research Center, Max Delbrück Center for Molecular Medicine and Charité-Universitätsmedizin Berlin, Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany
| | - Nancy L Sicotte
- Department of Neurology, Cedars Sinai Medical Center, Los Angeles, CA, USA
| | - Jared M Bruce
- Department of Biomedical and Health Informatics, School of Medicine, University of Missouri-Kansas City, Kansas City, MO, USA
| | - Peter A Arnett
- Department of Psychology, Penn State University, University Park, PA, USA
| | - Christoph Heesen
- Institut für Neuroimmunologie und Multiple Sklerose, Universitätklinikum Hamburg-Eppendorf, Hamburg, Germany
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Lopes RT, da Rocha GC, Svacina MA, Meyer B, Šipka D, Berger T. Effectiveness of an Internet-Based Self-Guided Program to Treat Depression in a Sample of Brazilian Users: Randomized Controlled Trial. JMIR Form Res 2023; 7:e46326. [PMID: 37590052 PMCID: PMC10472176 DOI: 10.2196/46326] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/07/2023] [Revised: 05/24/2023] [Accepted: 06/14/2023] [Indexed: 08/18/2023] Open
Abstract
BACKGROUND Depression is undertreated in Brazil. Deprexis is a self-guided internet-based program used to treat depressive symptoms based on empirically supported integrative and cognitive behavioral therapy. Evidence from a meta-analysis supports Deprexis' efficacy in German-speaking countries and the United States, but no study has been conducted using this program in countries with low literacy rates and large social disparities. Furthermore, few studies have investigated whether internet-based interventions ameliorate the psychological processes that might underlie depressive symptomatology, such as low perceived self-efficacy. OBJECTIVE The main objective of this study was to replicate in Brazil previously reported effects of Deprexis on depressive symptom reduction. Therefore, the main research question was whether Deprexis is effective in reducing depressive symptoms and the general psychological state in Brazilian users with moderate and severe depression in comparison with a control group that does not receive access to Deprexis. A secondary research question was whether the use of Deprexis affects perceptions of self-efficacy. METHODS We interviewed 312 participants recruited over the internet and randomized 189 participants with moderate to severe depression (according to the Patient Health Questionnaire-9 and a semistructured interview) to an intervention condition (treatment as usual plus immediate access to Deprexis for 90 days, n=94) or to a control condition (treatment as usual and delayed access to Deprexis, after 8 weeks, n=95). RESULTS Participants from the immediate access group logged in at Deprexis an average of 14.81 (SD 12.16) times. The intention-to-treat analysis using a linear mixed model showed that participants who received Deprexis improved significantly more than participants assigned to the delayed access control group on the primary depression self-assessment measure (Patient Health Questionnaire-9; Cohen d=0.80; P<.001) and secondary outcomes, such as general psychological state measure (Clinical Outcome in Routine Evaluation-Outcome Measurement; Cohen d=0.82; P<.001) and the perceived self-efficacy measure (Cohen d=0.63; P<.001). The intention-to-treat analyses showed that 21% (20/94) of the participants achieved remission compared with 7% (7/95) in the control group (P<.001). The deterioration rates were lower in the immediate access control group. The dropout rate was high, but no differences in demographic and clinical variables were found. Participants reported a medium to high level of satisfaction with Deprexis. CONCLUSIONS These results replicate previous findings by showing that Deprexis can facilitate symptomatic improvement over 3 months in depressed samples of Brazilian users. From a public health perspective, this is important information to expand the reach of internet-based interventions for those who really need them, especially in countries with less access to mental health care. This extends previous research by showing significant effects on perceived self-efficacy. TRIAL REGISTRATION Registro Brasileiro de Ensaios Clíncos (ReBec) RBR-6kk3bx UTN U1111-1212-8998; https://ensaiosclinicos.gov.br/rg/RBR-6kk3bx/. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID) RR2-10.1590/1516-4446-2019-0582.
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Mäder M, Timpel P, Schönfelder T, Militzer-Horstmann C, Scheibe S, Heinrich R, Häckl D. Evidence requirements of permanently listed digital health applications (DiGA) and their implementation in the German DiGA directory: an analysis. BMC Health Serv Res 2023; 23:369. [PMID: 37069592 PMCID: PMC10108444 DOI: 10.1186/s12913-023-09287-w] [Citation(s) in RCA: 15] [Impact Index Per Article: 7.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/05/2022] [Accepted: 03/15/2023] [Indexed: 04/19/2023] Open
Abstract
BACKGROUND With its digital health application (DiGA)-system, Germany is considered one of Europe's pioneers in the field of evidence-based digital health. Incorporating DiGA into standard medical care must be based on evidence-based success factors; however, a comprehensive overview of the evidence required of scientific studies for their approval is lacking. OBJECTIVE The study aims to, (1) identify specific requirements defined by the Federal Institute for Drugs and Medical Devices (German: Bundesinstitut für Arzneimittel- und Medizinprodukte; BfArM) to design adequate studies, proving a positive healthcare effect, and (2) to assess the evidence given for applications permanently listed in the DiGA directory. METHODS A multi-step approach was used: (1) identification of the evidence requirements for applications permanently listed in the DiGA directory, (2) identification of the evidence available supporting them. RESULTS All DiGA permanently listed in the DiGA directory (13 applications) are included in the formal analysis. Most DiGA addressed mental health (n = 7), and can be prescribed for one or two indications (n = 10). All permanently listed DiGA have demonstrated their positive healthcare effect through a medical benefit, and most of them provide evidence for one defined primary endpoint. All DiGA manufacturers conducted a randomized controlled trial. DISCUSSION It is striking that- although patient-relevant structural and procedural improvements show high potential for improving care, especially in terms of processes - all DiGA have provided a positive care effect via a medical benefit. Although BfArM accepts study designs with a lower level of evidence for the proof of a positive healthcare effect, all manufacturers conducted a study with a high level of evidence. CONCLUSION The results of this analysis indicate that permanently listed DiGA meet higher standards than required by the guideline.
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Affiliation(s)
- Melanie Mäder
- Faculty of Economics and Management Science, Leipzig University, Chair for Health Economics and Management, Leipzig, Germany.
- Scientific Institute for Health Economics and Health System Research (WIG2 GmbH), Markt 8, 04109, Leipzig, Germany.
| | - Patrick Timpel
- Scientific Institute for Health Economics and Health System Research (WIG2 GmbH), Markt 8, 04109, Leipzig, Germany
| | - Tonio Schönfelder
- Scientific Institute for Health Economics and Health System Research (WIG2 GmbH), Markt 8, 04109, Leipzig, Germany
- Department of Health Sciences/Public Health, Dresden University, Dresden, Germany
| | - Carsta Militzer-Horstmann
- Faculty of Economics and Management Science, Leipzig University, Chair for Health Economics and Management, Leipzig, Germany
- Scientific Institute for Health Economics and Health System Research (WIG2 GmbH), Markt 8, 04109, Leipzig, Germany
| | - Sandy Scheibe
- Scientific Institute for Health Economics and Health System Research (WIG2 GmbH), Markt 8, 04109, Leipzig, Germany
- Department of Health Sciences/Public Health, Dresden University, Dresden, Germany
| | - Ria Heinrich
- Scientific Institute for Health Economics and Health System Research (WIG2 GmbH), Markt 8, 04109, Leipzig, Germany
| | - Dennis Häckl
- Faculty of Economics and Management Science, Leipzig University, Chair for Health Economics and Management, Leipzig, Germany
- Scientific Institute for Health Economics and Health System Research (WIG2 GmbH), Markt 8, 04109, Leipzig, Germany
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22
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Manchanda N, Aggarwal A, Setya S, Talegaonkar S. Digital Intervention For The Management Of Alzheimer's Disease. Curr Alzheimer Res 2023; 19:CAR-EPUB-129308. [PMID: 36744687 DOI: 10.2174/1567205020666230206124155] [Citation(s) in RCA: 2] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/27/2022] [Revised: 01/08/2023] [Accepted: 01/12/2023] [Indexed: 02/07/2023]
Abstract
Alzheimer's disease (AD) is a progressive, multifactorial, chronic, neurodegenerative disease with high prevalence and limited therapeutic options, making it a global health crisis. Being the most common cause of dementia, AD erodes the cognitive, functional, and social abilities of the individual and causes escalating medical and psychosocial needs. As yet, this disorder has no cure and current treatment options are palliative in nature. There is an urgent need for novel therapy to address this pressing challenge. Digital therapeutics (Dtx) is one such novel therapy that is gaining popularity globally. Dtx provides evidence based therapeutic interventions driven by internet and software, employing tools such as mobile devices, computers, videogames, apps, sensors, virtual reality aiding in the prevention, management, and treatment of ailments like neurological abnormalities and chronic diseases. Dtx acts as a supportive tool for the optimization of patient care, individualized treatment and improved health outcomes. Dtx uses visual, sound and other non-invasive approaches for instance-consistent therapy, reminiscence therapy, computerised cognitive training, semantic and phonological assistance devices, wearables and computer-assisted rehabilitation environment to find applications in Alzheimer's disease for improving memory, cognition, functional abilities and managing motor symptom. A few of the Dtx-based tools employed in AD include "Memory Matters", "AlzSense", "Alzheimer Assistant", "smart robotic dog", "Immersive virtual reality (iVR)" and the most current gamma stimulation. The purpose of this review is to summarize the current trends in digital health in AD and explore the benefits, challenges, and impediments of using Dtx as an adjunctive therapy for the management of AD.
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Affiliation(s)
- Namish Manchanda
- School of Pharmaceutical Sciences, Delhi Pharmaceutical Sciences & Research University, Govt. of NCT of Delhi, New Delhi-110017, India
| | - Akanksha Aggarwal
- Delhi Institute of Pharmaceutical Sciences And Research, Delhi Pharmaceutical Sciences & Research University, Govt. of NCT of Delhi, New Delhi-110017, India
| | - Sonal Setya
- Department of Pharmacy Practice, SGT College of Pharmacy, SGT University, Gurugram, Haryana-122505, India
| | - Sushama Talegaonkar
- School of Pharmaceutical Sciences, Delhi Pharmaceutical Sciences & Research University, Govt. of NCT of Delhi, New Delhi-110017, India
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23
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Garcia A, Yáñez AM, Bennasar-Veny M, Navarro C, Salva J, Ibarra O, Gomez-Juanes R, Serrano-Ripoll MJ, Oliván B, Gili M, Roca M, Riera-Serra P, Aguilar-Latorre A, Montero-Marin J, Garcia-Toro M. Efficacy of an adjuvant non-face-to-face multimodal lifestyle modification program for patients with treatment-resistant major depression: A randomized controlled trial. Psychiatry Res 2023; 319:114975. [PMID: 36442318 DOI: 10.1016/j.psychres.2022.114975] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/25/2022] [Revised: 11/18/2022] [Accepted: 11/20/2022] [Indexed: 11/23/2022]
Abstract
BACKGROUND The high prevalence of depression is partly attributable to the poor response of patients to first-line antidepressants. Multimodal programs that promote a healthy lifestyle are successful in treating depression when used as a complementary therapy, but their medium- and long-term benefits have not been demonstrated for patients with treatment-resistant depression (TRD). The main aim of this study was to compare the effectiveness of a lifestyle modification program (LMP) with mindfulness-based cognitive therapy (MBCT) and a placebo-control (written suggestions for lifestyle changes) in Spanish patients with TRD. METHODS This controlled clinical trial randomized 94 patients with TRD into 3 arms. The primary outcome was the Beck Depression Inventory-II (BDI-II) score at baseline, 2, 6 and 12 months. The secondary outcomes were changes in scores that evaluated quality-of-life, adherence to the Mediterranean diet, physical activity, and social support. RESULTS Relative to the placebo group, the LMP and MBCT groups had significantly better quality of life (p = 0.017; p = 0.027), and the LMP group had significantly better adherence to the Mediterranean diet (p<0.001) and reduced use of antidepressants (p = 0.036). However, the three groups showed no significant differences in BDI-II score. LIMITATIONS Only about half of the planned 180 patients were recruited, in part due to the COVID-19 pandemic. CONCLUSIONS There was no evidence that the LMP treatment significantly reduced symptoms of depression relative to the other groups during the COVID-19 lockdown.
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Affiliation(s)
- Aurora Garcia
- Health Research Institute of the Balearic Islands (IdISBa), Spain; University Institute of Health Science Research (IUNICS), University of the Balearic Islands (UIB), Spain
| | - Aina M Yáñez
- Health Research Institute of the Balearic Islands (IdISBa), Spain; Department of Nursing and Physiotherapy and Research Group on Global Health and Human Development, UIB
| | - Miquel Bennasar-Veny
- Health Research Institute of the Balearic Islands (IdISBa), Spain; Department of Nursing and Physiotherapy and Research Group on Global Health and Human Development, UIB; CIBER de Epidemiologíública (CIBERESP), Instituto de Salud Carlos III (ISCIII), Madrid, Spain.
| | - Capilla Navarro
- Health Research Institute of the Balearic Islands (IdISBa), Spain; University Institute of Health Science Research (IUNICS), University of the Balearic Islands (UIB), Spain
| | - Joan Salva
- Health Research Institute of the Balearic Islands (IdISBa), Spain; University Institute of Health Science Research (IUNICS), University of the Balearic Islands (UIB), Spain; Department of Medicine, University of the Balearic Islands, E-07122 Palma, Spain
| | - Olga Ibarra
- Health Research Institute of the Balearic Islands (IdISBa), Spain; University Institute of Health Science Research (IUNICS), University of the Balearic Islands (UIB), Spain
| | - Rocío Gomez-Juanes
- Health Research Institute of the Balearic Islands (IdISBa), Spain; University Institute of Health Science Research (IUNICS), University of the Balearic Islands (UIB), Spain; Department of Medicine, University of the Balearic Islands, E-07122 Palma, Spain
| | - María J Serrano-Ripoll
- Primary Care Research Unit of Majorca, Balearic Islands Health Services and Department of Psychology, UIB
| | - Bárbara Oliván
- Department of Psychology and Sociology, University of Zaragoza. Primary Care Prevention and Health Promotion Research Network (RedIAPP), Zaragoza, Spain
| | - Margalida Gili
- Health Research Institute of the Balearic Islands (IdISBa), Spain; University Institute of Health Science Research (IUNICS), University of the Balearic Islands (UIB), Spain
| | - Miquel Roca
- Health Research Institute of the Balearic Islands (IdISBa), Spain; University Institute of Health Science Research (IUNICS), University of the Balearic Islands (UIB), Spain; Department of Medicine, University of the Balearic Islands, E-07122 Palma, Spain
| | - Pau Riera-Serra
- Health Research Institute of the Balearic Islands (IdISBa), Spain; University Institute of Health Science Research (IUNICS), University of the Balearic Islands (UIB), Spain
| | | | - Jesús Montero-Marin
- Department of Psychiatry, Warneford Hospital, University of Oxford, Oxford, UK; Teaching, Research & Innovation Unit, Parc Sanitari Sant Joan de Déu, Sant Boi de Llobregat, Spain
| | - Mauro Garcia-Toro
- Health Research Institute of the Balearic Islands (IdISBa), Spain; University Institute of Health Science Research (IUNICS), University of the Balearic Islands (UIB), Spain; Department of Medicine, University of the Balearic Islands, E-07122 Palma, Spain
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Orsolini L, Appignanesi C, Pompili S, Volpe U. The role of digital tools in providing youth mental health: results from an international multi-center study. Int Rev Psychiatry 2022; 34:809-826. [PMID: 36786119 DOI: 10.1080/09540261.2022.2118521] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 10/14/2022]
Abstract
Since the traditional mental health system showed significant limitations in the early identification, diagnosis and treatment of the current new youth psychopathological trajectories, by substantially failing in targeting the needs of the current young generation, there is the demand to redesign and digitally adapt youth mental health care and systems. Indeed, the level of digital literacy and the level of digital competency and knowledge in the field of digital psychiatry is still under-investigated among mental health professionals, particularly in youth mental health. Therefore, we aimed at: (a) carrying out a post-hoc analysis of an international multi-centre study, to investigate the opinions of mental health professionals regarding the feasibility, efficacy and clinical experience in delivering digital mental health interventions (DMHIs) in youths; (b) providing a comprehensive overview on the integrated digitally-based youth mental health care models and innovations. Mental health professionals declared the lack of a formal training in digital psychiatry, particularly in youth mental health. Subjects who received a formal theoretical/practical training on DMHIs displayed a statistical trend towards a positive feasibility of digital psychiatry in youth mental health (p = 0.053) and a perceived increased efficacy of digital psychiatry in youths (p = 0.051). Respondents with higher Digital Psychiatry Opinion (DPO) scores reported a positive perceived feasibility of DMHIs in youths (p < 0.041) and are more prone to deliver DMHIs to young people (p < 0.001). Respondents with higher knowledge scores (KS) declared that DMHIs are more effective in youth mental health (p < 0.001). Overall, the digitalisation indeed allowed young people to keep in touch with a mental health professional, facilitating a more dynamic and fluid mental health care access and monitoring, generally preferred and considered more feasible by post-Millennial youngsters. Accordingly, our findings demonstrated that mental health professionals are more prone to offer DMHIs in youth mental health, particularly whether previously trained and knowledgeable on the topic.
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Affiliation(s)
- Laura Orsolini
- Unit of Clinical Psychiatry, Department of Clinical Neurosciences/DIMSC, Polytechnic University of Marche, Ancona, Italy
| | - Cristina Appignanesi
- Unit of Clinical Psychiatry, Department of Clinical Neurosciences/DIMSC, Polytechnic University of Marche, Ancona, Italy
| | - Simone Pompili
- Unit of Clinical Psychiatry, Department of Clinical Neurosciences/DIMSC, Polytechnic University of Marche, Ancona, Italy
| | - Umberto Volpe
- Unit of Clinical Psychiatry, Department of Clinical Neurosciences/DIMSC, Polytechnic University of Marche, Ancona, Italy
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25
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Krause N, Riemann-Lorenz K, Rahn AC, Pöttgen J, Köpke S, Meyer B, Thale F, Temmes H, van de Loo M, Gold SM, Heesen C. 'That would have been the perfect thing after diagnosis': development of a digital lifestyle management application in multiple sclerosis. Ther Adv Neurol Disord 2022; 15:17562864221118729. [PMID: 36092248 PMCID: PMC9459469 DOI: 10.1177/17562864221118729] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/14/2022] [Accepted: 07/22/2022] [Indexed: 11/23/2022] Open
Abstract
Background A multiple sclerosis (MS) diagnosis urges decision-making on immunotherapies, while persons with MS (PwMS) need to develop a coping concept in parallel. At this stage, PwMS ask how they themselves may contribute to controlling the disease. Evidence suggests that maintaining a healthy lifestyle (e.g. physical activity and stress management) is a key factor for healthy aging and preserving activity, while data on MS are complex. Objectives Following the Medical Research Council framework, this study aimed to develop and investigate the feasibility of a new digital health application that conveys evidence-based patient information about lifestyle factors in MS and engages PwMS in relevant behaviour change techniques. Methods Based on a digital health application promoting lifestyle management in breast cancer survivors, an MS-specific adaptation ('levidex') was developed. Feasibility was tested with 15 PwMS and eight MS experts. Subsequently, a six-week pilot study with eight PwMS was conducted. All participants provided feedback on practicability and acceptability via a questionnaire and took part in a semi-structured telephone interview. Levidex was revised after each test phase. Results The final levidex tool includes 16 modules, 177 references and several other functions. Feasibility results showed that PwMS and MS experts perceived levidex as understandable (14 out of 15; 6 out of 8), trustworthy (15 out of 15; 8 out of 8), and relevant (10 out of 15; 8 out of 8). Interviews revealed potential for improvement regarding the length and complexity of some content. Piloting of the revised version confirmed good feasibility and high acceptance. Most participants felt inspired to initiate (7 out of 8) or had already implemented (5 out of 8) lifestyle changes after working with levidex. Conclusion Results suggest that levidex is feasible and well-accepted by PwMS and MS experts. It might be a useful tool to support PwMS in adapting to their diagnosis and initiating health-promoting lifestyle changes.
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Affiliation(s)
- Nicole Krause
- Institute of Neuroimmunology and Multiple
Sclerosis (INIMS), University Medical Center Hamburg-Eppendorf,
Martinistraße 52, 20246 Hamburg, Germany
| | - Karin Riemann-Lorenz
- Institute of Neuroimmunology and Multiple
Sclerosis (INIMS), University Medical Center Hamburg-Eppendorf, Hamburg,
Germany
| | - Anne Christin Rahn
- Institute of Neuroimmunology and Multiple
Sclerosis (INIMS), University Medical Center Hamburg-Eppendorf, Hamburg,
Germany
- Nursing Research Unit, Institute for Social
Medicine and Epidemiology, University of Lübeck, Lübeck, Germany
| | - Jana Pöttgen
- Institute of Neuroimmunology and Multiple
Sclerosis (INIMS), University Medical Center Hamburg-Eppendorf, Hamburg,
Germany
- Department of Neurology, University Medical
Center Hamburg-Eppendorf, Hamburg, Germany
| | - Sascha Köpke
- Institute of Nursing Science, Faculty of
Medicine, University of Cologne and University Hospital Cologne, Cologne,
Germany
| | - Björn Meyer
- Research and Development Department, GAIA
Group, Hamburg, Germany
| | - Frithjof Thale
- Research and Development Department, GAIA
Group, Hamburg, Germany
| | - Herbert Temmes
- German Multiple Sclerosis Society, Federal
Association, Hannover, Germany
| | - Markus van de Loo
- German Multiple Sclerosis Society, Federal
Association, Hannover, Germany
| | - Stefan M. Gold
- Institute of Neuroimmunology and Multiple
Sclerosis (INIMS), University Medical Center Hamburg-Eppendorf, Hamburg,
Germany
- Charité–Universitätsmedizin Berlin, Klinik für
Psychiatrie und Psychotherapie und Med. Klinik m.S. Psychosomatik, Berlin,
Germany
| | - Christoph Heesen
- Institute of Neuroimmunology and Multiple
Sclerosis (INIMS), University Medical Center Hamburg-Eppendorf, Hamburg,
Germany
- Department of Neurology, University Medical
Center Hamburg-Eppendorf, Hamburg, Germany
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26
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Luo X, Bugatti M, Molina L, Tilley JL, Mahaffey B, Gonzalez A. Conceptual Invariance, Trajectories, and Outcome Associations of Working Alliance in Unguided and Guided Internet-Based Psychological Interventions: Secondary Analysis of a Randomized Controlled Trial. JMIR Ment Health 2022; 9:e35496. [PMID: 35727626 PMCID: PMC9257617 DOI: 10.2196/35496] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/07/2021] [Revised: 05/03/2022] [Accepted: 05/06/2022] [Indexed: 11/13/2022] Open
Abstract
BACKGROUND The role of working alliance remains unclear for many forms of internet-based interventions (IBIs), a set of effective psychotherapy alternatives that do not require synchronous interactions between patients and therapists. OBJECTIVE This study examined the conceptual invariance, trajectories, and outcome associations of working alliance across an unguided IBI and guided IBIs that incorporated clinician support through asynchronous text messaging or video messaging. METHODS Adults with high education attainment (n=145) with subclinical levels of anxiety, stress, or depressive symptoms were randomized to 1 of 3 treatment conditions for 7 weeks. All participants received treatments from MyCompass, an unguided IBI using cognitive behavior therapy. Participants in condition 2 and 3 received supplemental, asynchronous clinician support through text and video, respectively. Working alliance with the IBIs was measured weekly using select items from the 12-item version of the Agnew Relationship Measure. Symptom and functional outcomes were assessed at baseline, at the end of treatment, and 1-month follow-up. RESULTS Working alliance with the IBIs was conceptually invariant across the 3 conditions. Working alliance followed a quadratic pattern of change over time for all conditions and declined significantly only in the text-support condition. After controlling for baseline symptoms, higher baseline levels of working alliance predicted less depression and less functional impairment at follow-up, whereas faster increases in working alliance predicted less worry at the end of treatment and at follow-up, all of which only occurred in the video-support condition. CONCLUSIONS Working alliance with the IBIs was generally established in the initial sessions. Although working alliance is conceptually invariant across IBIs with or without clinician support, the associations between working alliance and treatment outcomes among IBIs may differ depending on clinician involvement and the modalities of support. TRIAL REGISTRATION ClinicalTrials.gov NCT05122429; https://clinicaltrials.gov/ct2/show/NCT05122429.
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Affiliation(s)
- Xiaochen Luo
- Department of Counseling Psychology, Santa Clara University, Santa Clara, CA, United States
| | - Matteo Bugatti
- Morgridge College of Education, University of Denver, Denver, CO, United States
| | - Lucero Molina
- Department of Psychiatry, Stony Brook University, Stony Brook, NY, United States
| | - Jacqueline L Tilley
- Psychological and Child & Human Development Area Group, National Institute of Education, Nanyang Technological University, Singapore, Singapore
| | - Brittain Mahaffey
- Department of Psychiatry, Stony Brook University, Stony Brook, NY, United States
| | - Adam Gonzalez
- Department of Psychiatry, Stony Brook University, Stony Brook, NY, United States
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27
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Zhao C, Wampold BE, Ren Z, Zhang L, Jiang G. The efficacy and optimal matching of an Internet-based acceptance and commitment therapy intervention for depressive symptoms among university students: A randomized controlled trial in China. J Clin Psychol 2022; 78:1354-1375. [PMID: 35191525 DOI: 10.1002/jclp.23329] [Citation(s) in RCA: 5] [Impact Index Per Article: 1.7] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/25/2021] [Revised: 12/23/2021] [Accepted: 01/22/2022] [Indexed: 11/06/2022]
Abstract
OBJECTIVE The present study tested the efficacy of an unguided internet-based Acceptance and Commitment Therapy (iACT) program for depression, and identified the psychological characteristics of participants who benefitted the most from the program. METHOD Undergraduate students with mild to severe symptoms of depression were randomized to the iACT group (n = 95) or the waiting-list group (WLC group; n = 87). Depressive symptoms and positive mental health were assessed at baseline (T0 ), at the end of the 6-week program (T1 ), and at a 3-month follow-up (T2 ). RESULTS Compared with the WLC group, the iACT group showed significantly more improvement in depressive symptoms (d = 1.27) and positive mental health (d = 0.59), both at T1 and T2 . Latent Profile Analysis identified three classes of participants: Sensitive-to-Relationship, Low-Reactive-Depression, and Endogenous-Depression group. In general, the treatment was particularly suitable for the Sensitive-to-Relationship class. CONCLUSION The iACT was effective in treating the depressive symptoms of undergraduates, especially suitable for the clients with high baseline depression, high externality, high resistance, and high sensitivity to relationships.
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Affiliation(s)
- Chunxiao Zhao
- School of Psychology, Central China Normal University, Wuhan, China.,Key Laboratory of Adolescent Cyberpsychology and Behavior, Ministry of Education, Wuhan, China.,Key Laboratory of Human Development and Mental Health of Hubei Province, Wuhan, China
| | - Bruce E Wampold
- Modum Bad Psychiatric Center, Vikersund, Norway.,Department of Counseling Psychology, University of Wisconsin-Madison, Madison, USA
| | - Zhihong Ren
- School of Psychology, Central China Normal University, Wuhan, China.,Key Laboratory of Adolescent Cyberpsychology and Behavior, Ministry of Education, Wuhan, China.,Key Laboratory of Human Development and Mental Health of Hubei Province, Wuhan, China
| | - Lin Zhang
- School of Psychology, Central China Normal University, Wuhan, China.,Key Laboratory of Adolescent Cyberpsychology and Behavior, Ministry of Education, Wuhan, China.,Key Laboratory of Human Development and Mental Health of Hubei Province, Wuhan, China
| | - Guangrong Jiang
- School of Psychology, Central China Normal University, Wuhan, China.,Key Laboratory of Adolescent Cyberpsychology and Behavior, Ministry of Education, Wuhan, China.,Key Laboratory of Human Development and Mental Health of Hubei Province, Wuhan, China
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28
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Leong QY, Sridhar S, Blasiak A, Tadeo X, Yeo G, Remus A, Ho D. Characteristics of Mobile Health Platforms for Depression and Anxiety: Content Analysis Through a Systematic Review of the Literature and Systematic Search of Two App Stores. J Med Internet Res 2022; 24:e27388. [PMID: 35119370 PMCID: PMC8857696 DOI: 10.2196/27388] [Citation(s) in RCA: 11] [Impact Index Per Article: 3.7] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/23/2021] [Revised: 06/05/2021] [Accepted: 11/08/2021] [Indexed: 12/20/2022] Open
Abstract
Background Mobile health (mHealth) platforms show promise in the management of mental health conditions such as anxiety and depression. This has resulted in an abundance of mHealth platforms available for research or commercial use. Objective The objective of this review is to characterize the current state of mHealth platforms designed for anxiety or depression that are available for research, commercial use, or both. Methods A systematic review was conducted using a two-pronged approach: searching relevant literature with prespecified search terms to identify platforms in published research and simultaneously searching 2 major app stores—Google Play Store and Apple App Store—to identify commercially available platforms. Key characteristics of the mHealth platforms were synthesized, such as platform name, targeted condition, targeted group, purpose, technology type, intervention type, commercial availability, and regulatory information. Results The literature and app store searches yielded 169 and 179 mHealth platforms, respectively. Most platforms developed for research purposes were designed for depression (116/169, 68.6%), whereas the app store search reported a higher number of platforms developed for anxiety (Android: 58/179, 32.4%; iOS: 27/179, 15.1%). The most common purpose of platforms in both searches was treatment (literature search: 122/169, 72.2%; app store search: 129/179, 72.1%). With regard to the types of intervention, cognitive behavioral therapy and referral to care or counseling emerged as the most popular options offered by the platforms identified in the literature and app store searches, respectively. Most platforms from both searches did not have a specific target age group. In addition, most platforms found in app stores lacked clinical and real-world evidence, and a small number of platforms found in the published research were available commercially. Conclusions A considerable number of mHealth platforms designed for anxiety or depression are available for research, commercial use, or both. The characteristics of these mHealth platforms greatly vary. Future efforts should focus on assessing the quality—utility, safety, and effectiveness—of the existing platforms and providing developers, from both commercial and research sectors, a reporting guideline for their platform description and a regulatory framework to facilitate the development, validation, and deployment of effective mHealth platforms.
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Affiliation(s)
- Qiao Ying Leong
- N.1 Institute for Health, National University of Singapore, Singapore, Singapore.,The Institute for Digital Medicine (WisDM), Yong Loo Lin School of Medicine, National University of Singapore, Singapore, Singapore
| | - Shreya Sridhar
- N.1 Institute for Health, National University of Singapore, Singapore, Singapore
| | - Agata Blasiak
- N.1 Institute for Health, National University of Singapore, Singapore, Singapore.,The Institute for Digital Medicine (WisDM), Yong Loo Lin School of Medicine, National University of Singapore, Singapore, Singapore.,Department of Biomedical Engineering, NUS Engineering, National University of Singapore, Singapore, Singapore.,Department of Pharmacology, Yong Loo Lin School of Medicine, National University of Singapore, Singapore, Singapore
| | - Xavier Tadeo
- N.1 Institute for Health, National University of Singapore, Singapore, Singapore.,The Institute for Digital Medicine (WisDM), Yong Loo Lin School of Medicine, National University of Singapore, Singapore, Singapore
| | - GeckHong Yeo
- N.1 Institute for Health, National University of Singapore, Singapore, Singapore.,The Institute for Digital Medicine (WisDM), Yong Loo Lin School of Medicine, National University of Singapore, Singapore, Singapore
| | - Alexandria Remus
- N.1 Institute for Health, National University of Singapore, Singapore, Singapore.,The Institute for Digital Medicine (WisDM), Yong Loo Lin School of Medicine, National University of Singapore, Singapore, Singapore.,Department of Biomedical Engineering, NUS Engineering, National University of Singapore, Singapore, Singapore
| | - Dean Ho
- N.1 Institute for Health, National University of Singapore, Singapore, Singapore.,The Institute for Digital Medicine (WisDM), Yong Loo Lin School of Medicine, National University of Singapore, Singapore, Singapore.,Department of Biomedical Engineering, NUS Engineering, National University of Singapore, Singapore, Singapore.,Department of Pharmacology, Yong Loo Lin School of Medicine, National University of Singapore, Singapore, Singapore.,Health District @ Queenstown, Singapore, Singapore
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29
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Timakum T, Xie Q, Song M. Analysis of E-mental health research: mapping the relationship between information technology and mental healthcare. BMC Psychiatry 2022; 22:57. [PMID: 35078432 PMCID: PMC8787445 DOI: 10.1186/s12888-022-03713-9] [Citation(s) in RCA: 10] [Impact Index Per Article: 3.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/22/2021] [Accepted: 01/14/2022] [Indexed: 12/12/2022] Open
Abstract
BACKGROUND E-mental healthcare is the convergence of digital technologies with mental health services. It has been developed to fill a gap in healthcare for people who need mental wellbeing support that may not otherwise receive psychological treatment. With an increasing number of e-mental healthcare and research, this study aimed to investigate the trends of an e-mental health research field that integrates interdisciplinary fields and to examine the information technologies is being used in mental healthcare. To achieve the research objectives, bibliometric analysis, information extraction, and network analysis were applied to analyze e-mental health research data. METHODS E-mental health research data were obtained from 3663 bibliographic records from the Web of Science (WoS) and 3172 full-text articles from PubMed Central (PMC). The text mining techniques used for this study included bibliometric analysis, information extraction, and visualization. RESULTS The e-mental health research topic trends primarily involved e-health care services and medical informatics research. The clusters of research comprised 16 clusters, which refer to mental sickness, e-health, diseases, information technology (IT), and self-management. The information extraction analysis revealed a triple relation with IT and biomedical domains. Betweenness centrality was used as a measure of network graph centrality, based on the shortest path to rank the important entities and triple relation; nodes with higher betweenness centrality had greater control over the network because more information passes through that node. The IT entity-relations of "mobile" had the highest score at 0.043466. The top pairs were related to depression, mobile health, and text message. CONCLUSIONS E-mental related publications were associated with various research fields, such as nursing, psychology, medical informatics, computer science, telecommunication, and healthcare innovation. We found that trends in e-mental health research are continually rising. These trends were related to the internet of things (IoT) and mobile applications (Apps), which were applied for mental healthcare services. Moreover, producing AI and machine learning for e-mental healthcare were being studied. This work supports the appropriate approaches and methods of e-mental health research that can help the researcher to identify important themes and choose the best fit with their own survey work.
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Affiliation(s)
- Tatsawan Timakum
- grid.440397.d0000 0001 0516 2525Department of Information Sciences, Chiang Mai Rajabhat University, Chiang Mai, Thailand
| | - Qing Xie
- grid.464445.30000 0004 1790 3863School of Management, Shenzhen Polytechnic, Shenzhen, Guangdong China
| | - Min Song
- Department of Library and Information Science, Yonsei University, 50 Yonsei-ro, Seodaemun-gu, Seoul, 120-749, Republic of Korea.
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30
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Wang X, Feng Z. A Narrative Review of Empirical Literature of Behavioral Activation Treatment for Depression. Front Psychiatry 2022; 13:845138. [PMID: 35546948 PMCID: PMC9082162 DOI: 10.3389/fpsyt.2022.845138] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/29/2021] [Accepted: 03/28/2022] [Indexed: 12/04/2022] Open
Abstract
Grounded in the profound tradition of behaviorism theory and research, behavioral activation (BA) has become a standalone psychotherapy for depression. It is simple, straightforward, and easy to comprehend, with comparable efficacy to traditional CBT, and has developed into an evidence-based guided self-help intervention. The main work in the theoretical models and treatment manuals, as well as empirical evidence of the effectiveness of BA for (comorbid) depression in primary and medical care setting are introduced. With the rise of the third wave of CBT, therapeutic components across diagnoses will be incorporated into BA (e.g., mindfulness). Extensive studies are required to examine the neurobiological reward mechanism of BA for depression, and to explore the feasibility and necessity of e-mental health BA application into the public healthcare system in China.
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Affiliation(s)
- Xiaoxia Wang
- Department of Basic Psychology, School of Psychology, Army Medical University, Chongqing, China
| | - Zhengzhi Feng
- School of Psychology, Army Medical University, Chongqing, China
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31
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Meyer B, Utter GL, Hillman C. A Personalized, Interactive, Cognitive Behavioral Therapy-Based Digital Therapeutic (MODIA) for Adjunctive Treatment of Opioid Use Disorder: Development Study. JMIR Ment Health 2021; 8:e31173. [PMID: 34623309 PMCID: PMC8538017 DOI: 10.2196/31173] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/23/2021] [Revised: 07/28/2021] [Accepted: 08/02/2021] [Indexed: 01/30/2023] Open
Abstract
BACKGROUND Opioid use disorder (OUD) is characterized by the inability to control opioid use despite attempts to stop use and negative consequences to oneself and others. The burden of opioid misuse and OUD is a national crisis in the United States with substantial public health, social, and economic implications. Although medication-assisted treatment (MAT) has demonstrated efficacy in the management of OUD, access to effective counseling and psychosocial support is a limiting factor and a significant problem for many patients and physicians. Digital therapeutics are an innovative class of interventions that help prevent, manage, or treat diseases by delivering therapy using software programs. These applications can circumvent barriers to uptake, improve treatment adherence, and enable broad delivery of evidence-based management strategies to meet service gaps. However, few digital therapeutics specifically targeting OUD are available, and additional options are needed. OBJECTIVE To this end, we describe the development of the novel digital therapeutic MODIA. METHODS MODIA was developed by an international, multidisciplinary team that aims to provide effective, accessible, and sustainable management for patients with OUD. Although MODIA is aligned with principles of cognitive behavioral therapy, it was not designed to present any 1 specific treatment and uses a broad range of evidence-based behavior change techniques drawn from cognitive behavioral therapy, mindfulness, acceptance and commitment therapy, and motivational interviewing. RESULTS MODIA uses proprietary software that dynamically tailors content to the users' responses. The MODIA program comprises 24 modules or "chats" that patients are instructed to work through independently. Patient responses dictate subsequent content, creating a "simulated dialogue" experience between the patient and program. MODIA also includes brief motivational text messages that are sent regularly to prompt patients to use the program and help them transfer therapeutic techniques into their daily routines. Thus, MODIA offers individuals with OUD a custom-tailored, interactive digital psychotherapy intervention that maximizes the personal relevance and emotional impact of the interaction. CONCLUSIONS As part of a clinician-supervised MAT program, MODIA will allow more patients to begin psychotherapy concurrently with opioid maintenance treatment. We expect access to MODIA will improve the OUD management experience and provide sustainable positive outcomes for patients.
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32
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Lin A, Espay AJ. Remote delivery of cognitive behavioral therapy to patients with functional neurological disorders: Promise and challenges. Epilepsy Behav Rep 2021; 16:100469. [PMID: 34409282 PMCID: PMC8361291 DOI: 10.1016/j.ebr.2021.100469] [Citation(s) in RCA: 5] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/17/2021] [Revised: 06/29/2021] [Accepted: 07/03/2021] [Indexed: 11/03/2022] Open
Abstract
CBT is a promising treatment for patients with FND. Remote delivery of CBT can potentially increase access to care for patients with FND. Remote CBT can be integrated into clinical practice using a stepwise approach. Remote CBT can be integrated into practice using patient predictive factors. Functional neurological disorders (FND) are an important source of healthcare utilization and morbidity. While there are no formal guidelines for treating these disorders, cognitive behavioral therapy (CBT) is emerging as a safe and effective treatment. Currently, there is a global shortage of CBT providers, with only a small subset trained in and comfortable with treating patients with FND. We highlight four types of remote CBT delivery to patients with FND to alleviate the access obstacle: workbooks, internet-guided CBT, app-based CBT, and teletherapy. CBT workbooks and teletherapy have been studied in FND, with preliminary studies suggesting efficacy; internet-guided CBT and app-based CBT have not but have been effectively used in patients with psychiatric disorders, particularly depression, anxiety, and post-traumatic disorders. As these disorders are often comorbid and share overlapping neurobiology with FND, internet-guided CBT and app-based CBT represent promising delivery options of CBT for FND. Although remotely-delivered CBT is unlikely to replace in-person CBT and there are technical and logistical challenges to overcome prior to widespread deployment, it holds promise as an adjunct treatment when in-person CBT is inaccessible. We propose a rational approach to future allocation of remote CBT treatment options and highlight important research gaps to bridge beforehand.
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Affiliation(s)
- Amanda Lin
- The Ohio State University Wexner Medical Center, 410 W 10th Ave, Columbus, OH 43210, United States
| | - Alberto J Espay
- James J. and Joan A. Gardner Family Center for Parkinson's Disease and Movement Disorders, Department of Neurology, University of Cincinnati, Cincinnati, OH, United States
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33
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Alavi N, Stephenson C, Omrani M, Gerritsen C, Martin MS, Knyahnytskyi A, Zhu Y, Kumar A, Jagayat J, Shirazi A, Moghimi E, Patel C, Knyahnytska Y, Simpson AIF, Zaheer J, Andersen J, Munshi A, Groll D. Delivering an Online Cognitive Behavioral Therapy Program to Address Mental Health Challenges Faced by Correctional Workers and Other Public Safety Personnel: Protocol for a Mixed Methods Study. JMIR Res Protoc 2021; 10:e30845. [PMID: 34088656 PMCID: PMC8367142 DOI: 10.2196/30845] [Citation(s) in RCA: 8] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/31/2021] [Accepted: 06/03/2021] [Indexed: 01/01/2023] Open
Abstract
BACKGROUND Public safety personnel have regular and often intense exposure to potentially traumatic events at work, especially workplace violence in the case of correctional workers. Subsequently, correctional workers are at higher risk of developing mental health problems such as posttraumatic stress disorder. Public safety personnel are up to 4 times more likely to experience suicidal ideation, suicidal attempts, and death by suicide compared to the general population. Despite this high prevalence, help-seeking behaviors from public safety personnel are low due to stigma and irregular work hours limiting access to care. Innovative treatments are needed to address these challenges. OBJECTIVE This study will investigate the efficacy of an electronically delivered cognitive behavioral therapy (e-CBT) program tailored to correctional workers' mental health problems. METHODS This study is composed of 4 phases. In phase 1, we will interview correctional workers individually and in focus groups to identify personal, social, and cultural factors affecting their mental health and barriers to care. Phase 2 will use the information gathered from the interviews to develop gender- and diagnosis-specific e-CBT modules. These will be presented to a new group of participants who will provide further feedback on their usability and accessibility. In phase 3, we will randomly assign participants to either an e-CBT or treatment as usual arm. The program will be evaluated with validated symptomatology questionnaires and interviews. Phase 4 will use this additional information to fine-tune the e-CBT modules for a larger-scale randomized controlled trial design comparing the e-CBT program to in-person CBT. All e-CBT modules will be delivered through a secure online platform. RESULTS The study received ethics approval in December 2020, and participant recruitment began in March 2021. Participant recruitment has been conducted through targeted advertisements and physician referrals. To date, there have been 15 participants recruited for Phase 1, and it is expected to conclude in July 2021, with phase 2 beginning in September 2021. Complete data collection and analysis from all phases are expected to conclude by July 2023. Linear and binomial regression (for continuous and categorical outcomes, respectively) will be conducted along with interpretive qualitative methods. CONCLUSIONS If proven efficacious and feasible, this e-CBT program can provide a high-quality and clinically validated resource to address the mental health problems of correctional workers. Additionally, findings can contribute to the development of innovative treatments for other public safety professions. TRIAL REGISTRATION ClinicalTrials.gov NCT04666974; https://www.clinicaltrials.gov/ct2/show/NCT04666974. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID) DERR1-10.2196/30845.
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Affiliation(s)
- Nazanin Alavi
- Department of Psychiatry, Faculty of Health Sciences, Queen's University, Kingston, ON, Canada
- Centre for Neuroscience Studies, Faculty of Health Sciences, Queen's University, Kingston, ON, Canada
| | - Callum Stephenson
- Department of Psychiatry, Faculty of Health Sciences, Queen's University, Kingston, ON, Canada
- Centre for Neuroscience Studies, Faculty of Health Sciences, Queen's University, Kingston, ON, Canada
| | - Mohsen Omrani
- Department of Psychiatry, Faculty of Health Sciences, Queen's University, Kingston, ON, Canada
- Centre for Neuroscience Studies, Faculty of Health Sciences, Queen's University, Kingston, ON, Canada
- OPTT Inc, Toronto, ON, Canada
| | - Cory Gerritsen
- Forensic Early Intervention Service, Centre for Addiction and Mental Health, Toronto, ON, Canada
- Department of Psychiatry, University of Toronto, Toronto, ON, Canada
- Department of Psychological Clinical Science, University of Toronto, Toronto, ON, Canada
| | - Michael S Martin
- Health Services Sector, Correctional Service Canada, Ottawa, ON, Canada
- School of Epidemiology and Public Health, University of Ottawa, Ottawa, ON, Canada
| | - Alex Knyahnytskyi
- Department of Psychiatry, Faculty of Health Sciences, Queen's University, Kingston, ON, Canada
| | - Yiran Zhu
- Faculty of Health Sciences, Queen's Unviersity, Kingston, ON, Canada
| | - Anchan Kumar
- Department of Psychiatry, Faculty of Health Sciences, Queen's University, Kingston, ON, Canada
| | - Jasleen Jagayat
- Department of Psychiatry, Faculty of Health Sciences, Queen's University, Kingston, ON, Canada
| | - Amirhossein Shirazi
- Department of Psychiatry, Faculty of Health Sciences, Queen's University, Kingston, ON, Canada
- Centre for Neuroscience Studies, Faculty of Health Sciences, Queen's University, Kingston, ON, Canada
- OPTT Inc, Toronto, ON, Canada
| | - Elnaz Moghimi
- Department of Psychiatry, Faculty of Health Sciences, Queen's University, Kingston, ON, Canada
| | - Charmy Patel
- Department of Psychiatry, Faculty of Health Sciences, Queen's University, Kingston, ON, Canada
| | - Yuliya Knyahnytska
- Department of Psychiatry, University of Toronto, Toronto, ON, Canada
- General Psychiatry Division, Centre for Addiction and Mental Health, Toronto, ON, Canada
| | - Alexander I F Simpson
- Department of Forensic Psychiatry, Centre for Addiction and Mental Health, Toronto, ON, Canada
| | - Juveria Zaheer
- Institute for Mental Health Policy Research, Centre for Addiction and Mental Health, Toronto, ON, Canada
| | - Judith Andersen
- Department of Psychology, University of Toronto Mississauga, Mississauga, ON, Canada
| | - Alpna Munshi
- Department of Psychiatry, University of Toronto, Toronto, ON, Canada
| | - Dianne Groll
- Department of Psychiatry, Faculty of Health Sciences, Queen's University, Kingston, ON, Canada
- Canadian Institute for Military and Veteran Health Research, Kingston, ON, Canada
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Heissel A, Bollmann J, Kangas M, Abdulla K, Rapp M, Sanchez A. Validation of the German version of the work and social adjustment scale in a sample of depressed patients. BMC Health Serv Res 2021; 21:593. [PMID: 34154599 PMCID: PMC8218495 DOI: 10.1186/s12913-021-06622-x] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/20/2021] [Accepted: 05/21/2021] [Indexed: 11/14/2022] Open
Abstract
BACKGROUND Depression is one of the key factors contributing to difficulties in one's ability to work, and serves as one of the major reasons why employees apply for psychotherapy and receive insurance subsidization of treatments. Hence, an increasing and growing number of studies rely on workability assessment scales as their primary outcome measure. The Work and Social Assessment Scale (WSAS) has been documented as one of the most psychometrically reliable and valid tools especially developed to assess workability and social functioning in patients with mental health problems. Yet, the application of the WSAS in Germany has been limited due to the paucity of a valid questionnaire in the German language. The objective of the present study was to translate the WSAS, as a brief and easy administrable tool into German and test its psychometric properties in a sample of adults with depression. METHODS Two hundred seventy-seven patients (M = 48.3 years, SD = 11.1) with mild to moderately severe depression were recruited. A multistep translation from English into the German language was performed and the factorial validity, criterion validity, convergent validity, discriminant validity, internal consistency, and floor and ceiling effects were examined. RESULTS The confirmatory factor analysis results confirmed the one-factor structure of the WSAS. Significant correlations with the WHODAS 2-0 questionnaire, a measure of functionality, demonstrated good convergent validity. Significant correlations with depression and quality of life demonstrated good criterion validity. The WSAS also demonstrated strong internal consistency (α = .89), and the absence of floor and ceiling effects indicated good sensitivity of the instrument. CONCLUSIONS The results of the present study demonstrated that the German version of the WSAS has good psychometric properties comparable to other international versions of this scale. The findings recommend a global assessment of psychosocial functioning with the sum score of the WSAS. TRIAL REGISTRATION ISRCTN identifier: ISRCTN28972230 . Date of registration June 26th 2018.
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Affiliation(s)
- A. Heissel
- Department of Sport and Health Sciences, Intra-faculty Cognition Sciences, Faculty of Human Science, and Faculty of Health Sciences Brandenburg, Research Area Services Research and e-Health, University of Potsdam, Potsdam, Germany
| | - J. Bollmann
- Social and Preventive Medicine, Department of Sports and Health Sciences, University of Potsdam, Potsdam, Germany
| | - M. Kangas
- Maria Kangas, Department of Psychology, Centre for Emotional Health, Macquarie University, Sydney, 2109 Australia
| | - K. Abdulla
- Social and Preventive Medicine, Department of Sports and Health Sciences, University of Potsdam, Potsdam, Germany
| | - M. Rapp
- Department of Sport and Health Sciences, Intra-faculty Cognition Sciences, Faculty of Human Science, and Faculty of Health Sciences Brandenburg, Research Area Services Research and e-Health, University of Potsdam, Potsdam, Germany
| | - A. Sanchez
- Social and Preventive Medicine, Department of Sports and Health Sciences, University of Potsdam, Potsdam, Germany
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The effects of Pythagorean Self-Awareness Intervention on patients with major depressive disorder: A pilot randomized controlled trial. J Psychiatr Res 2021; 138:326-334. [PMID: 33894540 DOI: 10.1016/j.jpsychires.2021.03.067] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/28/2020] [Revised: 03/26/2021] [Accepted: 03/31/2021] [Indexed: 11/20/2022]
Abstract
Stress plays an important role in major depressive disorder (MDD). Thus, a variety of stress management programs have been developed for people with this diagnosis. This is a pilot randomized clinical trial which implemented a holistic stress management program, Pythagorean Self-Awareness Intervention (PSAI) in adults with MDD, aiming to evaluate the effectiveness of PSAI compared to standard care for reduction of depressive symptoms (primary aim), improving mental health and quality of life (secondary aims). A total of 69 participants were randomized to an intervention group (N = 34), who received the usual care provided for patients with major depression and attended the PSAI program, and a control group (N = 35), who received the usual care only. Measurements were taken in both groups before and after the intervention and included: 1. Self-report questionnaires for measuring depressive symptoms, healthy lifestyle, perceived stress, anxiety, positive and negative affect and sleep quality, 2 Cognitive function assessment tools, 3. Hair and salivary cortisol. The intervention group demonstrated significantly greater reductions in depressive symptoms, negative affect, perceived stress, sleep quality and significantly greater increase in visual memory and healthy lifestyle compared to the control group. In addition, the intervention group demonstrated a significant reduction in first morning salivary cortisol, indicating a reduction in diurnal stress levels, while no significant change of salivary cortisol was observed in the control group. Finally, none of the study's groups demonstrated a significant change in hair cortisol concentration. In conclusion, PSAI can be applied to adults suffering from MDD with significant benefits for their mental health and quality of life. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04536714.
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Imamura K, Tran TTT, Nguyen HT, Sasaki N, Kuribayashi K, Sakuraya A, Bui TM, Nguyen AQ, Nguyen QT, Nguyen NT, Nguyen KT, Nguyen GTH, Tran XTN, Truong TQ, Zhang MW, Minas H, Sekiya Y, Watanabe K, Tsutsumi A, Kawakami N. Effect of smartphone-based stress management programs on depression and anxiety of hospital nurses in Vietnam: a three-arm randomized controlled trial. Sci Rep 2021; 11:11353. [PMID: 34059737 PMCID: PMC8166974 DOI: 10.1038/s41598-021-90320-5] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/16/2020] [Accepted: 05/11/2021] [Indexed: 12/16/2022] Open
Abstract
There are growing concerns on stress among nurses in low- and middle-income countries (LMICs) in South-East Asia. It is important to improve mental health among nurses in these countries. The objective of this study was to examine the efficacy of two types of newly developed smartphone-based stress management programs in improving depressive and anxiety symptoms among hospital nurses in Vietnam. This study was a three-arm (including two intervention groups and one control group) randomized trial. Participants were recruited from nurses in a large general hospital in Hanoi, Vietnam. Two types (free-choice and fixed sequential order) of smartphone-based stress management programs were developed. Participants were randomly allocated to Program A (a free-choice, multimodule stress management), Program B (a fixed-order, internet cognitive behavioral therapy, iCBT), or a control group (treatment as usual). The depressive and anxiety symptoms were measured by using the Depression Anxiety and Stress Scales at baseline, 3-, and 7-month follow-up surveys. 951 participants were randomly allocated to each of the three groups. Program B showed a statistically significant effect on improving depressive symptoms at 3-month (p = 0.048), but not at 7-month (p = 0.92); Cohen's d was - 0.18 (95% CI - 0.34 to - 0.02) and 0.03 (95% CI - 1.00 to 1.05), respectively. Program A failed to show a significant intervention effect on any of the outcomes at 3- or 7-month follow-up (p > 0.05). Despite the small effect size, the present fixed-order iCBT program seems effective in improving depression of hospital nurses in Vietnam. A public health impact of the intervention can be scalable, when considering its accessibility and minimal cost.Trial registration number: The study protocol is registered at the UMIN Clinical Trials Registry (UMINCTR; ID = UMIN000033139). Registered date of the protocol is 1st Jul. 2018. https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037796.
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Affiliation(s)
- Kotaro Imamura
- Department of Mental Health, Graduate School of Medicine, The University of Tokyo, 7-3-1, Hongo, Bunkyo-ku, Tokyo, 113-0033, Japan
| | - Thuy Thi Thu Tran
- Department of Occupational Health and Safety, Faculty of Environmental and Occupational Health, Hanoi University of Public Health, Hanoi, Vietnam
| | - Huong Thanh Nguyen
- Faculty of Social and Behavioral Sciences, Hanoi University of Public Health, Hanoi, Vietnam
| | - Natsu Sasaki
- Department of Mental Health, Graduate School of Medicine, The University of Tokyo, 7-3-1, Hongo, Bunkyo-ku, Tokyo, 113-0033, Japan
| | - Kazuto Kuribayashi
- Department of Mental Health and Psychiatric Nursing, Graduate School of Health Care Sciences, Tokyo Medical and Dental University, Tokyo, Japan
| | - Asuka Sakuraya
- Division of Public Health, Department of Hygiene and Public Health, School of Medicine, Tokyo Women's Medical University, Tokyo, Japan
| | - Thu Minh Bui
- Nursing Office, Bach Mai Hospital, Hanoi, Vietnam
| | | | - Quynh Thuy Nguyen
- Department of Occupational Health and Safety, Faculty of Environmental and Occupational Health, Hanoi University of Public Health, Hanoi, Vietnam
| | - Nga Thi Nguyen
- Faculty of Social and Behavioral Sciences, Hanoi University of Public Health, Hanoi, Vietnam
| | - Kien Trung Nguyen
- Faculty of Social and Behavioral Sciences, Hanoi University of Public Health, Hanoi, Vietnam
| | | | | | - Tien Quang Truong
- Faculty of Social and Behavioral Sciences, Hanoi University of Public Health, Hanoi, Vietnam
| | - Melvyn Weibin Zhang
- National Addiction Management Service, Institute of Mental Health, Singapore, Singapore
| | - Harry Minas
- Melbourne School of Population and Global Health, The University of Melbourne, Melbourne, Australia
| | - Yuki Sekiya
- Department of Mental Health, Graduate School of Medicine, The University of Tokyo, 7-3-1, Hongo, Bunkyo-ku, Tokyo, 113-0033, Japan
| | - Kazuhiro Watanabe
- Department of Public Health, Kitasato University School of Medicine, Sagamihara, Japan
| | - Akizumi Tsutsumi
- Department of Public Health, Kitasato University School of Medicine, Sagamihara, Japan
| | - Norito Kawakami
- Department of Mental Health, Graduate School of Medicine, The University of Tokyo, 7-3-1, Hongo, Bunkyo-ku, Tokyo, 113-0033, Japan.
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Abbadessa G, Brigo F, Clerico M, De Mercanti S, Trojsi F, Tedeschi G, Bonavita S, Lavorgna L. Digital therapeutics in neurology. J Neurol 2021; 269:1209-1224. [PMID: 34018047 PMCID: PMC8136262 DOI: 10.1007/s00415-021-10608-4] [Citation(s) in RCA: 51] [Impact Index Per Article: 12.8] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/13/2021] [Revised: 05/05/2021] [Accepted: 05/08/2021] [Indexed: 12/14/2022]
Abstract
Digital therapeutics (DTx) is a section of digital health defined by the DTx Alliance as “delivering evidence-based therapeutic interventions to patients that are driven by software to prevent, manage, or treat a medical disorder or disease. They are used independently or in concert with medications, devices, or other therapies to optimize patient care and health outcomes”. Chronic disabling diseases could greatly benefit from DTx. In this narrative review, we provide an overview of DTx in the care of patients with neurological dysfunctions.
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Affiliation(s)
- G Abbadessa
- Division of Neurology, University of Campania Luigi Vanvitelli, Naples, Italy
| | - F Brigo
- Department of Neurology, Hospital of Merano (SABES-ASDAA), 39012, Naples, Italy
| | - M Clerico
- Clinical and Biological Sciences Department, University of Torino, 10124, Turin, Italy
| | - S De Mercanti
- Clinical and Biological Sciences Department, University of Torino, 10124, Turin, Italy
| | - F Trojsi
- Division of Neurology, University of Campania Luigi Vanvitelli, Naples, Italy
| | - G Tedeschi
- Division of Neurology, University of Campania Luigi Vanvitelli, Naples, Italy
| | - S Bonavita
- Division of Neurology, University of Campania Luigi Vanvitelli, Naples, Italy
| | - L Lavorgna
- Division of Neurology, University of Campania Luigi Vanvitelli, Naples, Italy.
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McCall HC, Hadjistavropoulos HD, Sundström CRF. Exploring the Role of Persuasive Design in Unguided Internet-Delivered Cognitive Behavioral Therapy for Depression and Anxiety Among Adults: Systematic Review, Meta-analysis, and Meta-regression. J Med Internet Res 2021; 23:e26939. [PMID: 33913811 PMCID: PMC8120424 DOI: 10.2196/26939] [Citation(s) in RCA: 26] [Impact Index Per Article: 6.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/23/2021] [Revised: 02/14/2021] [Accepted: 04/11/2021] [Indexed: 12/12/2022] Open
Abstract
BACKGROUND Internet-delivered cognitive behavioral therapy (ICBT) is an effective treatment that can overcome barriers to mental health care. Various research groups have suggested that unguided ICBT (ie, ICBT without therapist support) and other eHealth interventions can be designed to enhance user engagement and thus outcomes. The persuasive systems design framework captures most design recommendations for eHealth interventions, but there is little empirical evidence that persuasive design is related to clinical outcomes in unguided ICBT. OBJECTIVE This study aims to provide an updated meta-analysis of randomized controlled trials of unguided ICBT for depression and anxiety, describe the frequency with which various persuasive design principles are used in such interventions, and use meta-regression to explore whether a greater number of persuasive design elements predicts efficacy in unguided ICBT for depression and anxiety. METHODS We conducted a systematic review of 5 databases to identify randomized controlled trials of unguided ICBT for depression and anxiety. We conducted separate random effects meta-analyses and separate meta-regressions for depression and anxiety interventions. Each meta-regression included 2 steps. The first step included, as a predictor, whether each intervention was transdiagnostic. For the meta-regression of ICBT for depression, the first step also included the type of control condition. The number of persuasive design principles identified for each intervention was added as a predictor in the second step to reveal the additional variance in effect sizes explained by persuasive design. RESULTS Of the 4471 articles we identified in our search, 46 (1.03%) were eligible for inclusion in our analyses. Our meta-analyses showed effect sizes (Hedges g) ranging from 0.22 to 0.31 for depression interventions, depending on the measures taken to account for bias in the results. We found a mean effect size of 0.45 (95% CI 0.33-0.56) for anxiety interventions, with no evidence that the results were inflated by bias. Included interventions were identified as using between 1 and 13 persuasive design principles, with an average of 4.95 (SD 2.85). The meta-regressions showed that a greater number of persuasive design principles predicted greater efficacy in ICBT for depression (R2 change=0.27; B=0.04; P=.02) but not anxiety (R2 change=0.05; B=0.03; P=.17). CONCLUSIONS These findings show wide variability in the use of persuasive design in unguided ICBT for depression and anxiety and provide preliminary support for the proposition that more persuasively designed interventions are more efficacious, at least in the treatment of depression. Further research is needed to clarify the role of persuasive design in ICBT.
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Affiliation(s)
- Hugh C McCall
- Department of Psychology, University of Regina, Regina, SK, Canada
- PSPNET, University of Regina, Regina, SK, Canada
| | - Heather D Hadjistavropoulos
- Department of Psychology, University of Regina, Regina, SK, Canada
- PSPNET, University of Regina, Regina, SK, Canada
| | - Christopher Richard Francis Sundström
- Department of Clinical Neuroscience, Centre for Psychiatry Research, Karolinska Institutet, Stockholm, Sweden
- Department of Psychology, Stockholm University, Stockholm, Sweden
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Krämer R, Köhler S. Evaluation of the online-based self-help programme "Selfapy" in patients with unipolar depression: study protocol for a randomized, blinded parallel group dismantling study. Trials 2021; 22:264. [PMID: 33836810 PMCID: PMC8034195 DOI: 10.1186/s13063-021-05218-4] [Citation(s) in RCA: 8] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/01/2020] [Accepted: 03/22/2021] [Indexed: 11/17/2022] Open
Abstract
Background Patients with mild to moderate depressive symptoms can have limited access to regular treatment; to ensure appropriate care, low-threshold treatment is needed. Effective online interventions could increase the supply of low-threshold treatment. Further research is needed to evaluate the effectiveness of online interventions. This study aims to evaluate the online-based self-help programme “Selfapy” on a sample of depressive subjects and compares the impact of the programme’s unaccompanied version with its therapeutic accompanied version. Methods A sample of 400 subjects that have a mild to severe depressive episode (Becks Depression Inventory - II and Hamilton Depression Scale) will be used. Subjects are randomly assigned to immediate access to an unaccompanied course (no support from psychologist via weekly phone calls), immediate access to an accompanied course (support from a psychologist via weekly phone calls) or a waiting list control group (access to the intervention after 24 weeks). The intervention will last for a period of 12 weeks. Depressive symptoms as a primary parameter, as well as various secondary parameters, such as life satisfaction, therapeutic relationships, social activation, self-esteem, attitudes towards Internet interventions and drop-out rates, are recorded at four different points in time: at baseline (T1), 6 weeks after the start of the intervention (T2), 12 weeks after the start of the intervention (T3) and 3 months after completion of the treatment follow-up (T4). Conclusion This randomized and controlled, blinded study will make use of a “dismantled” approach to adequately compare the accompanied and unaccompanied versions of the intervention. Positive and meaningful results are expected that could influence the acceptance and implementation of online interventions. Trial registration German Clinical Trials Register DRKS00017191. Registered on 14 June 2019
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Affiliation(s)
- Rico Krämer
- Department of Psychiatry and Psychotherapy, Charité - Universitätsmedizin Berlin, Campus Mitte, Charitéplatz 1, 10117, Berlin, Germany.
| | - Stephan Köhler
- Department of Psychiatry and Psychotherapy, Charité - Universitätsmedizin Berlin, Campus Mitte, Charitéplatz 1, 10117, Berlin, Germany
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Karyotaki E, Efthimiou O, Miguel C, Bermpohl FMG, Furukawa TA, Cuijpers P, and the Individual Patient Data Meta-Analyses for Depression (IPDMA-DE) Collaboration. Internet-Based Cognitive Behavioral Therapy for Depression: A Systematic Review and Individual Patient Data Network Meta-analysis. JAMA Psychiatry 2021; 78:361-371. [PMID: 33471111 PMCID: PMC8027916 DOI: 10.1001/jamapsychiatry.2020.4364] [Citation(s) in RCA: 425] [Impact Index Per Article: 106.3] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/05/2020] [Accepted: 11/23/2020] [Indexed: 12/11/2022]
Abstract
Importance Personalized treatment choices would increase the effectiveness of internet-based cognitive behavioral therapy (iCBT) for depression to the extent that patients differ in interventions that better suit them. Objective To provide personalized estimates of short-term and long-term relative efficacy of guided and unguided iCBT for depression using patient-level information. Data Sources We searched PubMed, Embase, PsycInfo, and Cochrane Library to identify randomized clinical trials (RCTs) published up to January 1, 2019. Study Selection Eligible RCTs were those comparing guided or unguided iCBT against each other or against any control intervention in individuals with depression. Available individual patient data (IPD) was collected from all eligible studies. Depression symptom severity was assessed after treatment, 6 months, and 12 months after randomization. Data Extraction and Synthesis We conducted a systematic review and IPD network meta-analysis and estimated relative treatment effect sizes across different patient characteristics through IPD network meta-regression. Main Outcomes and Measures Patient Health Questionnaire-9 (PHQ-9) scores. Results Of 42 eligible RCTs, 39 studies comprising 9751 participants with depression contributed IPD to the IPD network meta-analysis, of which 8107 IPD were synthesized. Overall, both guided and unguided iCBT were associated with more effectiveness as measured by PHQ-9 scores than control treatments over the short term and the long term. Guided iCBT was associated with more effectiveness than unguided iCBT (mean difference [MD] in posttreatment PHQ-9 scores, -0.8; 95% CI, -1.4 to -0.2), but we found no evidence of a difference at 6 or 12 months following randomization. Baseline depression was found to be the most important modifier of the relative association for efficacy of guided vs unguided iCBT. Differences between unguided and guided iCBT in people with baseline symptoms of subthreshold depression (PHQ-9 scores 5-9) were small, while guided iCBT was associated with overall better outcomes in patients with baseline PHQ-9 greater than 9. Conclusions and Relevance In this network meta-analysis with IPD, guided iCBT was associated with more effectiveness than unguided iCBT for individuals with depression, benefits were more substantial in individuals with moderate to severe depression. Unguided iCBT was associated with similar effectiveness among individuals with symptoms of mild/subthreshold depression. Personalized treatment selection is entirely possible and necessary to ensure the best allocation of treatment resources for depression.
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Affiliation(s)
- Eirini Karyotaki
- Institute of Social and Preventive Medicine, University of Bern, Bern, Switzerland
- Department of Clinical Neuro- and Developmental Psychology, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands
- Department of Global Health and Social Medicine, Harvard Medical School, Boston, Massachusetts
| | - Orestis Efthimiou
- Institute of Social and Preventive Medicine, University of Bern, Bern, Switzerland
- Department of Psychiatry, University of Oxford, Oxford, England
| | - Clara Miguel
- Department of Clinical Neuro- and Developmental Psychology, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands
- Amsterdam Public Health Research Institute, Amsterdam, the Netherlands
| | | | - Toshi A. Furukawa
- Department of Clinical Psychology and Psychotherapy, University of Wuppertal, Wuppertal, Germany
- Department of Health Promotion and Human Behavior, Department of Clinical Epidemiology, Kyoto University Graduate School of Medicine/School of Public Health, Kyoto, Japan
| | - Pim Cuijpers
- Department of Clinical Neuro- and Developmental Psychology, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands
- Amsterdam Public Health Research Institute, Amsterdam, the Netherlands
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Lifestyle medicine for depression: A meta-analysis of randomized controlled trials. J Affect Disord 2021; 284:203-216. [PMID: 33609955 DOI: 10.1016/j.jad.2021.02.012] [Citation(s) in RCA: 35] [Impact Index Per Article: 8.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/03/2020] [Revised: 01/13/2021] [Accepted: 02/01/2021] [Indexed: 11/20/2022]
Abstract
BACKGROUND The treatment effect of multi-component LM interventions on depressive symptoms has not yet been examined. METHODS We systematically searched six databases from inception to February 2020 to identify randomized controlled trials (RCTs) involving any multi-component LM interventions (physical activity, nutritional advice, sleep management, and/or stress management) on depressive symptoms relative to care as usual (CAU), waitlist (WL), no intervention (NI), or attention control (AC) comparisons. RESULTS Fifty studies with 8,479 participants were included. Multi-component LM interventions reduced depressive symptoms significantly relative to the CAU (p >.001; d = 0.20) and WL/NI (p > .01; d = 0.22) comparisons at immediate posttreatment. However, no significant difference was found when compared with AC. The intervention effects were maintained in the short-term (1- to 3-month follow-up) relative to the CAU comparison (p > .05; d = 0.25), but not in the medium- and long-term. The moderator analyses examining the effect of multi-component LM interventions compared with CAU suggested that the number of lifestyle factors adopted was a significant moderator. Although disease type was not a significant moderator, there was a tendency that the clinical effect of multi-component LM interventions was stronger (d = 0.45) in those diagnosed with major depression. No publication bias was detected. LIMITATIONS Low number of RCTs available in some subgroup analyses prevented from finding meaningful effects. Results may not be extended to major depression, because data on secondary depression were captured. CONCLUSION Multi-component LM interventions appeared to be effective in mitigating depressive symptoms; however, the magnitude of the clinical effect was small. Future research is needed to assess more comprehensive and individualized LM interventions which have a greater emphasis on motivational and compliance aspects and focus solely on individuals with depression.
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Sasaki N, Imamura K, Tran TTT, Nguyen HT, Kuribayashi K, Sakuraya A, Bui TM, Nguyen QT, Nguyen NT, Nguyen GTH, Zhang MW, Minas H, Sekiya Y, Watanabe K, Tsutsumi A, Shimazu A, Kawakami N. Effects of Smartphone-Based Stress Management on Improving Work Engagement Among Nurses in Vietnam: Secondary Analysis of a Three-Arm Randomized Controlled Trial. J Med Internet Res 2021; 23:e20445. [PMID: 33620328 PMCID: PMC7943341 DOI: 10.2196/20445] [Citation(s) in RCA: 11] [Impact Index Per Article: 2.8] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/19/2020] [Revised: 09/03/2020] [Accepted: 10/17/2020] [Indexed: 01/16/2023] Open
Abstract
BACKGROUND Work engagement is important for employee well-being and work performance. However, no intervention study has investigated the effect of an eMental Health intervention on work engagement among workers in low- and middle-income countries (LMICs). OBJECTIVE The aim of the study was to examine the effects of a newly developed smartphone-based stress management program (ABC Stress Management) on improving work engagement among hospital nurses in Vietnam, an LMIC. METHODS Full-time registered nurses (n=949) were randomly assigned to one of 2 intervention groups or a control group. The intervention groups were a 6-week, 6-lesson program offering basic cognitive behavioral therapy (CBT-based stress management skills), provided in either free-choice (program A) or fixed order (program B). Work engagement was assessed at baseline and 3-month and 7-month follow-ups in each of the 3 groups. RESULTS The scores of work engagement in both intervention groups improved from baseline to 3-month follow-up, and then decreased at the 7-month follow-up, while the score steadily increased from baseline to 7-month follow-up in the control group. Program B showed a significant intervention effect on improving work engagement at the 3-month follow-up (P=.049) with a small effect size (Cohen d= 0.16; 95% CI 0.001 to 0.43]). Program A showed nonsignificant trend (d=0.13; 95% CI -0.014 to 0.41; P=.07) toward improved engagement at 3 months. Neither program achieved effectiveness at the 7-month follow-up. CONCLUSIONS The study demonstrated that a fixed order (program B) delivery of a smartphone-based stress management program was effective in improving work engagement in nurses in Vietnam. However, the effect was small and only temporary. Further improvement of this program is required to achieve a greater effect size and more sustained, longer lasting impact on work engagement. TRIAL REGISTRATION University Hospital Medical Information Network Clinical Trials Registry UMIN000033139; tinyurl.com/55gxo253. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID) RR2-10.1136/bmjopen-2018-025138.
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Affiliation(s)
- Natsu Sasaki
- Department of Mental Health, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan
| | - Kotaro Imamura
- Department of Mental Health, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan
| | - Thuy Thi Thu Tran
- Department of Occupational Health and Safety, Faculty of Environmental and Occupational Health, Hanoi University of Public Health, Hanoi, Vietnam
| | - Huong Thanh Nguyen
- Faculty of Social Sciences-Behavior and Health Education, Hanoi University of Public Health, Hanoi, Vietnam
| | - Kazuto Kuribayashi
- Department of Mental Health, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan
| | - Asuka Sakuraya
- Department of Public Health, Tokyo Women's Medical University, Tokyo, Japan
| | - Thu Minh Bui
- Nursing Office, Bach Mai Hospital, Hanoi, Vietnam
| | - Quynh Thuy Nguyen
- Department of Occupational Health and Safety, Faculty of Environmental and Occupational Health, Hanoi University of Public Health, Hanoi, Vietnam
| | - Nga Thi Nguyen
- Faculty of Social Sciences-Behavior and Health Education, Hanoi University of Public Health, Hanoi, Vietnam
| | | | - Melvyn Weibin Zhang
- National Addiction Management Service, Institute of Mental Health, Singapore, Singapore
| | - Harry Minas
- Melbourne School of Population and Global Health, The University of Melbourne, Melbourne, Australia
| | - Yuki Sekiya
- Department of Mental Health, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan
| | - Kazuhiro Watanabe
- Department of Mental Health, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan
| | - Akizumi Tsutsumi
- Department of Public Health, Kitasato University School of Medicine, Sagamihara, Japan
| | - Akihito Shimazu
- Faculty of Policy Management, Keio University, Kanagawa, Japan
| | - Norito Kawakami
- Department of Mental Health, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan
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Nolte S, Busija L, Berger T, Meyer B, Moritz S, Rose M, Schröder J, Späth-Nellissen C, Klein JP. Do sociodemographic variables moderate effects of an internet intervention for mild to moderate depressive symptoms? An exploratory analysis of a randomised controlled trial (EVIDENT) including 1013 participants. BMJ Open 2021; 11:e041389. [PMID: 33500282 PMCID: PMC7839881 DOI: 10.1136/bmjopen-2020-041389] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/22/2022] Open
Abstract
OBJECTIVE To explore the moderating effects of sociodemographic variables on treatment benefits received from participating in an internet intervention for depression. DESIGN Randomised, assessor-blind, controlled trial. SETTING Online intervention, with participant recruitment using multiple settings, including inpatient and outpatient medical and psychological clinics, depression online forums, health insurance companies and the media (eg, newspaper, radio). PARTICIPANTS The EVIDENT trial included 1013 participants with mild to moderate depressive symptoms. INTERVENTIONS The intervention group subjects (n=509) received an online intervention (Deprexis) in addition to care as usual (CAU), while 504 participants received CAU alone. METHODS To explore subgroup differences, moderating effects were investigated using linear regression models based on intention-to-treat analyses. Moderating effects included sex, age, educational attainment, employment status, relationship status and lifetime frequency of episodes. PRIMARY AND SECONDARY OUTCOME MEASURES The primary endpoint was change in self-rated depression severity measured by the Patient Health Questionnaire-9 (PHQ-9), comparing baseline versus 12-week post-test assessment. Secondary outcome measures were the Hamilton Rating Scale for Depression and the Quick Inventory of Depressive Symptoms each at 12 weeks and at 6 and 12 months, and PHQ-9 at 6 and 12 months, respectively. In this article, we focus on the primary outcome measure only. RESULTS Between-group differences were observed in post-test scores, indicating the effectiveness of Deprexis. While the effects of the intervention could be demonstrated across all subgroups, some showed larger between-group differences than others. However, after exploring the moderating effects based on linear regression models, none of the selected variables was found to be moderating treatment outcomes. CONCLUSIONS Our findings suggest that Deprexis is equally beneficial to a wide range of people; that is, participant characteristics were not associated with treatment benefits. Therefore, participant recruitment into web-based psychotherapeutic interventions should be broad, while special attention may be paid to those currently under-represented in these interventions. TRIAL REGISTRATION NUMBER NCT01636752.
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Affiliation(s)
- Sandra Nolte
- Medical Department, Division of Psychosomatic Medicine, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany
| | - Ljoudmila Busija
- Research Methodology Division, Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia
| | - Thomas Berger
- Department of Clinical Psychology and Psychotherapy, University of Bern, Bern, Switzerland
| | - Björn Meyer
- Research Department, GAIA AG, Hamburg, Germany
- Department of Psychology, City University London, London, UK
| | - Steffen Moritz
- Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany
| | - Matthias Rose
- Medical Department, Division of Psychosomatic Medicine, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany
| | - Johanna Schröder
- Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany
| | | | - Jan Philipp Klein
- Department of Psychiatry and Psychotherapy, Lübeck University, Lübeck, Germany
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Kaiser T, Boschloo L, Berger T, Meyer B, Späth-Nellissen C, Schröder J, Hohagen F, Moritz S, Klein JP. Maintaining Outcomes of Internet-Delivered Cognitive-Behavioral Therapy for Depression: A Network Analysis of Follow-Up Effects. Front Psychiatry 2021; 12:598317. [PMID: 33959044 PMCID: PMC8095668 DOI: 10.3389/fpsyt.2021.598317] [Citation(s) in RCA: 5] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/24/2020] [Accepted: 03/16/2021] [Indexed: 11/13/2022] Open
Abstract
Background: Depression is a highly prevalent mental disorder, but only a fraction of those affected receive evidence-based treatments. Recently, Internet-based interventions were introduced as an efficacious and cost-effective approach. However, even though depression is a heterogenous construct, effects of treatments have mostly been determined using aggregated symptom scores. This carries the risk of concealing important effects and working mechanisms of those treatments. Methods: In this study, we analyze outcome and long-term follow-up data from the EVIDENT study, a large (N = 1,013) randomized-controlled trial comparing an Internet intervention for depression (Deprexis) with care as usual. We use Network Intervention Analysis to examine the symptom-specific effects of the intervention. Using data from intermediary and long-term assessments that have been conducted over 36 months, we intend to reveal how the treatment effects unfold sequentially and are maintained. Results: Item-level analysis showed that scale-level effects can be explained by small item-level effects on most depressive symptoms at all points of assessment. Higher scores on these items at baseline predicted overall symptom reduction throughout the whole assessment period. Network intervention analysis offered insights into potential working mechanisms: while deprexis directly affected certain symptoms of depression (e.g., worthlessness and fatigue) and certain aspects of the quality of life (e.g., overall impairment through emotional problems), other domains were affected indirectly (e.g., depressed mood and concentration as well as activity level). The configuration of direct and indirect effects replicates previous findings from another study examining the same intervention. Conclusions: Internet interventions for depression are not only effective in the short term, but also exert long-term effects. Their effects are likely to affect only a small subset of problems. Patients reporting these problems are likely to benefit more from the intervention. Future studies on online interventions should examine symptom-specific effects as they potentially reveal the potential of treatment tailoring. Clinical Trial Registration: ClinicalTrials.gov, Identifier: NCT02178631.
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Affiliation(s)
- Tim Kaiser
- Department of Psychology, University of Salzburg, Salzburg, Austria.,Department of Psychology, University of Greifswald, Greifswald, Germany
| | - Lynn Boschloo
- Faculty of Behavioural and Movement Sciences, Clinical Psychology, Vrije Universiteit Amsterdam, Amsterdam, Netherlands
| | - Thomas Berger
- Department of Psychology, Bern University, Bern, Switzerland
| | | | | | - Johanna Schröder
- Department of Psychiatry and Psychotherapy, University Medical Center Hamburg Eppendorf, Hamburg, Germany
| | - Fritz Hohagen
- Department of Psychiatry, Lübeck University, Lübeck, Germany
| | - Steffen Moritz
- Department of Psychiatry and Psychotherapy, University Medical Center Hamburg Eppendorf, Hamburg, Germany
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LOPES RT, SVACINA MA, GÓMEZ-PENEDO JM, ROUSSOS A, MEYER B, BERGER T. Who seeks Internet-based interventions for depression in Brazil? ESTUDOS DE PSICOLOGIA (CAMPINAS) 2021. [DOI: 10.1590/1982-0275202138e190166] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/22/2022] Open
Abstract
Abstract Specific psychological treatments for depressive disorders delivered on the Internet have shown effectiveness and presented advantages over face-to-face treatments (potentially less expensive, flexible schedules, available in remote areas). This paper aims to describe the characteristics of those who sought help from an online self-guided intervention for depression and to explore hypotheses about predictors of enrollment to the program. Based on a sample of 282 of individuals who filled in screening questionnaires, we verified that the respondents were mainly female, were on average 34.36 years old, were primarily recruited through Facebook, had been previously diagnosed by mental health professionals, presented moderate self-efficacy perception, and had moderately severe symptoms of depression. Respondents who reported comorbid conditions were more likely to attend enrollment interviews, and being in treatment or not did not influence attendance. Such characterization may provide strategies to reach more people and to optimize the design of interventions targeting help-seeking depressed individuals in Brazil.
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Affiliation(s)
| | | | | | | | | | - Thomas BERGER
- University of Bern, Psychology Institute, Switzerland
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Hensel JM, Yang R, Vigod SN, Desveaux L. Videoconferencing at home for psychotherapy in the postpartum period: Identifying drivers of successful engagement and important therapeutic conditions for meaningful use. COUNSELLING & PSYCHOTHERAPY RESEARCH 2020. [DOI: 10.1002/capr.12372] [Citation(s) in RCA: 7] [Impact Index Per Article: 1.4] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/06/2022]
Affiliation(s)
| | - Rebecca Yang
- Women's College Hospital Institute for Health Systems Solutions and Virtual Care Toronto ON Canada
| | - Simone N. Vigod
- Department of Psychiatry University of Toronto Toronto ON Canada
| | - Laura Desveaux
- Women's College Hospital Institute for Health Systems Solutions and Virtual Care Toronto ON Canada
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Watzke B, Heddaeus D, Steinmann M, Daubmann A, Wegscheider K, Härter M. Does symptom severity matter in stepped and collaborative care for depression? J Affect Disord 2020; 277:287-295. [PMID: 32854052 DOI: 10.1016/j.jad.2020.07.079] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/25/2020] [Revised: 05/22/2020] [Accepted: 07/05/2020] [Indexed: 11/26/2022]
Abstract
BACKGROUND We investigated the differential effectiveness of a stepped and collaborative care model (SCM) vs. treatment as usual (TAU) for primary care patients with various depression severity degrees and explored whether subgroups received distinct evidence-based treatments. METHODS Subgroup analyses of a RCT were calculated applying a multiple linear mixed model with the factors 1. group (SCM; TAU), 2. severity ((mild-moderate (MMD); severe depression (SD)) and their interaction, with PHQ-9 as primary outcome. Utilization of treatments was analyzed descriptively. RESULTS For the 737 participating patients (SCM: n = 569; TAU: n = 168), availability of data substantially varies between subgroups at 12-month follow-up ranging between 37% and 70%. ITT-analysis (Last-observation-carried-forward) revealed a significant interaction for group x severity [p = 0.036] and a significant difference between groups in symptom reduction for MMD (-3.9; [95% CI: -5.1 to -2.6, p < 0.001; d = 0.64] but not for SD (-1.6; [95% CI: -3.4 to 0.2, p = 0.093; d = 0.27]. Sensitivity analyses (multiple imputation, completer analysis, pattern mixture model) didn`t confirm the interaction effect and showed significant effects for both severity groups with slightly higher effect sizes for MMD. Differences between SCM and TAU in the percentage of patients utilizing depression-specific treatments are larger for MMD. LIMITATIONS There was a high proportion of missing values among severely depressed patients, especially in SCM. CONCLUSION SCM is effective for both MMD and SD. Utilization patterns might help explain the higher effects for MMD. Various strategies of replacement of missing values lead to slightly divergent results due to selective drop out between severity groups.
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Affiliation(s)
- Birgit Watzke
- Clinical Psychology and Psychotherapy Research, Institute of Psychology, University of Zurich, Binzmühlestrasse 14/16, CH-8050 Zurich, Switzerland.
| | - Daniela Heddaeus
- Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Martinistraße 52, 20246 Hamburg, Germany.
| | - Maya Steinmann
- Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Martinistraße 52, 20246 Hamburg, Germany.
| | - Anne Daubmann
- Department of Medical Biometry and Epidemiology, University Medical Center Hamburg-Eppendorf, Martinistraße 52, 20246 Hamburg, Germany.
| | - Karl Wegscheider
- Department of Medical Biometry and Epidemiology, University Medical Center Hamburg-Eppendorf, Martinistraße 52, 20246 Hamburg, Germany.
| | - Martin Härter
- Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Martinistraße 52, 20246 Hamburg, Germany.
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Mukhiya SK, Wake JD, Inal Y, Pun KI, Lamo Y. Adaptive Elements in Internet-Delivered Psychological Treatment Systems: Systematic Review. J Med Internet Res 2020; 22:e21066. [PMID: 33245285 PMCID: PMC7732710 DOI: 10.2196/21066] [Citation(s) in RCA: 12] [Impact Index Per Article: 2.4] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/04/2020] [Revised: 08/19/2020] [Accepted: 10/26/2020] [Indexed: 12/17/2022] Open
Abstract
BACKGROUND Internet-delivered psychological treatments (IDPTs) are built on evidence-based psychological treatment models, such as cognitive behavioral therapy, and are adjusted for internet use. The use of internet technologies has the potential to increase access to evidence-based mental health services for a larger proportion of the population with the use of fewer resources. However, despite extensive evidence that internet interventions can be effective in the treatment of mental health disorders, user adherence to such internet intervention is suboptimal. OBJECTIVE This review aimed to (1) inspect and identify the adaptive elements of IDPT for mental health disorders, (2) examine how system adaptation influences the efficacy of IDPT on mental health treatments, (3) identify the information architecture, adaptive dimensions, and strategies for implementing these interventions for mental illness, and (4) use the findings to create a conceptual framework that provides better user adherence and adaptiveness in IDPT for mental health issues. METHODS The review followed the guidelines from Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA). The research databases Medline (PubMed), ACM Digital Library, PsycINFO, CINAHL, and Cochrane were searched for studies dating from January 2000 to January 2020. Based on predetermined selection criteria, data from eligible studies were analyzed. RESULTS A total of 3341 studies were initially identified based on the inclusion criteria. Following a review of the title, abstract, and full text, 31 studies that fulfilled the inclusion criteria were selected, most of which described attempts to tailor interventions for mental health disorders. The most common adaptive elements were feedback messages to patients from therapists and intervention content. However, how these elements contribute to the efficacy of IDPT in mental health were not reported. The most common information architecture used by studies was tunnel-based, although a number of studies did not report the choice of information architecture used. Rule-based strategies were the most common adaptive strategies used by these studies. All of the studies were broadly grouped into two adaptive dimensions based on user preferences or using performance measures, such as psychometric tests. CONCLUSIONS Several studies suggest that adaptive IDPT has the potential to enhance intervention outcomes and increase user adherence. There is a lack of studies reporting design elements, adaptive elements, and adaptive strategies in IDPT systems. Hence, focused research on adaptive IDPT systems and clinical trials to assess their effectiveness are needed.
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Affiliation(s)
| | | | | | - Ka I Pun
- Western Norway University of Applied Sciences, Bergen, Norway
| | - Yngve Lamo
- Western Norway University of Applied Sciences, Bergen, Norway
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Nieuwenhuijsen K, Verbeek JH, Neumeyer-Gromen A, Verhoeven AC, Bültmann U, Faber B. Interventions to improve return to work in depressed people. Cochrane Database Syst Rev 2020; 10:CD006237. [PMID: 33052607 PMCID: PMC8094165 DOI: 10.1002/14651858.cd006237.pub4] [Citation(s) in RCA: 60] [Impact Index Per Article: 12.0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/18/2022]
Abstract
BACKGROUND Work disability such as sickness absence is common in people with depression. OBJECTIVES To evaluate the effectiveness of interventions aimed at reducing work disability in employees with depressive disorders. SEARCH METHODS We searched CENTRAL (The Cochrane Library), MEDLINE, Embase, CINAHL, and PsycINFO until April 4th 2020. SELECTION CRITERIA We included randomised controlled trials (RCTs) and cluster-RCTs of work-directed and clinical interventions for depressed people that included days of sickness absence or being off work as an outcome. We also analysed the effects on depression and work functioning. DATA COLLECTION AND ANALYSIS Two review authors independently extracted the data and rated the certainty of the evidence using GRADE. We used standardised mean differences (SMDs) or risk ratios (RR) with 95% confidence intervals (CI) to pool study results in studies we judged to be sufficiently similar. MAIN RESULTS: In this update, we added 23 new studies. In total, we included 45 studies with 88 study arms, involving 12,109 participants with either a major depressive disorder or a high level of depressive symptoms. Risk of bias The most common types of bias risk were detection bias (27 studies) and attrition bias (22 studies), both for the outcome of sickness absence. Work-directed interventions Work-directed interventions combined with clinical interventions A combination of a work-directed intervention and a clinical intervention probably reduces days of sickness absence within the first year of follow-up (SMD -0.25, 95% CI -0.38 to -0.12; 9 studies; moderate-certainty evidence). This translates back to 0.5 fewer (95% CI -0.7 to -0.2) sick leave days in the past two weeks or 25 fewer days during one year (95% CI -37.5 to -11.8). The intervention does not lead to fewer persons being off work beyond one year follow-up (RR 0.96, 95% CI 0.85 to 1.09; 2 studies, high-certainty evidence). The intervention may reduce depressive symptoms (SMD -0.25, 95% CI -0.49 to -0.01; 8 studies, low-certainty evidence) and probably has a small effect on work functioning (SMD -0.19, 95% CI -0.42 to 0.06; 5 studies, moderate-certainty evidence) within the first year of follow-up. Stand alone work-directed interventions A specific work-directed intervention alone may increase the number of sickness absence days compared with work-directed care as usual (SMD 0.39, 95% CI 0.04 to 0.74; 2 studies, low-certainty evidence) but probably does not lead to more people being off work within the first year of follow-up (RR 0.93, 95% CI 0.77 to 1.11; 1 study, moderate-certainty evidence) or beyond (RR 1.00, 95% CI 0.82 to 1.22; 2 studies, moderate-certainty evidence). There is probably no effect on depressive symptoms (SMD -0.10, 95% -0.30 CI to 0.10; 4 studies, moderate-certainty evidence) within the first year of follow-up and there may be no effect on depressive symptoms beyond that time (SMD 0.18, 95% CI -0.13 to 0.49; 1 study, low-certainty evidence). The intervention may also not lead to better work functioning (SMD -0.32, 95% CI -0.90 to 0.26; 1 study, low-certainty evidence) within the first year of follow-up. Psychological interventions A psychological intervention, either face-to-face, or an E-mental health intervention, with or without professional guidance, may reduce the number of sickness absence days, compared with care as usual (SMD -0.15, 95% CI -0.28 to -0.03; 9 studies, low-certainty evidence). It may also reduce depressive symptoms (SMD -0.30, 95% CI -0.45 to -0.15, 8 studies, low-certainty evidence). We are uncertain whether these psychological interventions improve work ability (SMD -0.15 95% CI -0.46 to 0.57; 1 study; very low-certainty evidence). Psychological intervention combined with antidepressant medication Two studies compared the effect of a psychological intervention combined with antidepressants to antidepressants alone. One study combined psychodynamic therapy with tricyclic antidepressant (TCA) medication and another combined telephone-administered cognitive behavioural therapy (CBT) with a selective serotonin reuptake inhibitor (SSRI). We are uncertain if this intervention reduces the number of sickness absence days (SMD -0.38, 95% CI -0.99 to 0.24; 2 studies, very low-certainty evidence) but found that there may be no effect on depressive symptoms (SMD -0.19, 95% CI -0.50 to 0.12; 2 studies, low-certainty evidence). Antidepressant medication only Three studies compared the effectiveness of SSRI to selective norepinephrine reuptake inhibitor (SNRI) medication on reducing sickness absence and yielded highly inconsistent results. Improved care Overall, interventions to improve care did not lead to fewer days of sickness absence, compared to care as usual (SMD -0.05, 95% CI -0.16 to 0.06; 7 studies, moderate-certainty evidence). However, in studies with a low risk of bias, the intervention probably leads to fewer days of sickness absence in the first year of follow-up (SMD -0.20, 95% CI -0.35 to -0.05; 2 studies; moderate-certainty evidence). Improved care probably leads to fewer depressive symptoms (SMD -0.21, 95% CI -0.35 to -0.07; 7 studies, moderate-certainty evidence) but may possibly lead to a decrease in work-functioning (SMD 0.5, 95% CI 0.34 to 0.66; 1 study; moderate-certainty evidence). Exercise Supervised strength exercise may reduce sickness absence, compared to relaxation (SMD -1.11; 95% CI -1.68 to -0.54; one study, low-certainty evidence). However, aerobic exercise probably is not more effective than relaxation or stretching (SMD -0.06; 95% CI -0.36 to 0.24; 2 studies, moderate-certainty evidence). Both studies found no differences between the two conditions in depressive symptoms. AUTHORS' CONCLUSIONS A combination of a work-directed intervention and a clinical intervention probably reduces the number of sickness absence days, but at the end of one year or longer follow-up, this does not lead to more people in the intervention group being at work. The intervention may also reduce depressive symptoms and probably increases work functioning more than care as usual. Specific work-directed interventions may not be more effective than usual work-directed care alone. Psychological interventions may reduce the number of sickness absence days, compared with care as usual. Interventions to improve clinical care probably lead to lower sickness absence and lower levels of depression, compared with care as usual. There was no evidence of a difference in effect on sickness absence of one antidepressant medication compared to another. Further research is needed to assess which combination of work-directed and clinical interventions works best.
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Affiliation(s)
- Karen Nieuwenhuijsen
- Department of Public and Occupational Health, Coronel Institute of Occupational Health, Amsterdam Public Health research institute, Amsterdam UMC, University of Amsterdam, Academic Medical Center, Amsterdam, Netherlands
| | - Jos H Verbeek
- Cochrane Work Review Group, Department of Public and Occupational Health, Amsterdam Public Health research institute, Amsterdam UMC, University of Amsterdam, Academic Medical Center, Amsterdam, Netherlands
| | | | | | - Ute Bültmann
- Department of Health Sciences, Community and Occupational Medicine, University Medical Center Groningen, University of Groningen, Groningen, Netherlands
| | - Babs Faber
- Coronel Institute of Occupational Health/Dutch Research Center for Insurance Medicine, Academic Medical Center, University of Amsterdam, Amsterdam, Netherlands
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Hui VKY, Wong CYF, Ma EKY, Ho FYY, Chan CS. Treating depression with a smartphone-delivered self-help cognitive behavioral therapy for insomnia: study protocol for a parallel group randomized controlled trial. Trials 2020; 21:843. [PMID: 33036655 PMCID: PMC7545384 DOI: 10.1186/s13063-020-04778-1] [Citation(s) in RCA: 5] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/18/2020] [Accepted: 09/29/2020] [Indexed: 11/25/2022] Open
Abstract
Background Depression is a major public health concern. Emerging research has shown that cognitive behavioral therapy for insomnia (CBT-I) is effective in treating individuals with comorbid insomnia and depression. Traditional face-to-face CBT-I encounters many obstacles related to feasibility, accessibility, and help-seeking stigma. CBT-I delivered via smartphone application could be a potential solution. This paper reports a protocol designed to evaluate the efficacy of a self-help smartphone-based CBT-I, using a waitlist group as control, for people with major depression and insomnia. Methods A two-arm parallel randomized controlled trial is conducted in a target sample of 285 non-suicidal Hong Kong Chinese older than 17 years of age with major depression and insomnia. Participants complete an online rapid screening, followed by a telephone diagnostic interview. Those who meet the eligibility criteria are randomized in a ratio of 1:1 to receive either CBT-I immediately or to a waitlist control condition. The CBT-I consists of six weekly modules and is delivered through a smartphone application proACT-S. This smartphone app has been pilot tested and revamped to improve user experience. An online randomized algorithm is used to perform randomization to ensure allocation concealment. The primary outcomes are changes over the measurement points in sleep quality, insomnia severity, and depression severity. The secondary outcomes include changes over the measurement points in anxiety, subjective health, treatment expectancy, and acceptability of treatment. Assessments are administered at baseline, post-intervention, and 6-week follow-up. The recruitment is completed. Important adverse events, if any, are documented. Multilevel linear mixed model based on intention-to-treat principle will be conducted to examine the efficacy of the CBT-I intervention. Discussion It is expected that proACT-S is an efficacious brief sleep-focused self-help treatment for people with major depression and insomnia. If proven efficacious, due to its self-help nature, proACT-S may be applicable as a community-based early intervention, thereby reducing the burden of the public healthcare system in Hong Kong. Trial registration ClinicalTrials.gov NCT04228146. Retrospectively registered on 14 January 2020.
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Affiliation(s)
- Victoria Ka-Ying Hui
- Department of Psychology, The University of Hong Kong, Pokfulam Road, Hong Kong SAR, Hong Kong
| | - Christy Yim-Fan Wong
- Department of Psychology, The University of Hong Kong, Pokfulam Road, Hong Kong SAR, Hong Kong
| | - Eric Ka-Yiu Ma
- Department of Psychology, The University of Hong Kong, Pokfulam Road, Hong Kong SAR, Hong Kong
| | - Fiona Yan-Yee Ho
- Department of Psychology, The Chinese University of Hong Kong, Shatin, Hong Kong
| | - Christian S Chan
- Department of Psychology, The University of Hong Kong, Pokfulam Road, Hong Kong SAR, Hong Kong.
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