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Tatsumi K, Parfitt A, Weissfeld L, Opler M. Assessing negative symptoms of schizophrenia in the context of remote independent ratings: a psychometric evaluation of BNSS and PANSS. Schizophr Res 2025; 281:108-114. [PMID: 40328091 DOI: 10.1016/j.schres.2025.04.032] [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: 11/20/2024] [Revised: 04/25/2025] [Accepted: 04/28/2025] [Indexed: 05/08/2025]
Abstract
Previous traditional psychometric validation studies have demonstrated that the Brief Negative Symptom Scale (BNSS) and the Positive and Negative Syndrome Scale (PANSS) have satisfactory psychometric properties in patients with schizophrenia. The objective of the current study is to expand this literature by evaluating the psychometric properties of both scales in a large, multicenter, multicultural, randomized control clinical trial in patients with schizophrenia with predominantly negative symptoms. The current study employs independent ratings, in which raters are blinded from the study protocol and administer both scales via videoconference. The BNSS demonstrated excellent internal consistency (Cronbach's alpha = 0.93). The results of discriminant and concurrent validity analyses supported the construct validity of the assessment. The exploratory factor analysis of the PANSS identified five distinct factors. Overall, BNSS and PANSS demonstrate good psychometric properties that are comparable to previous findings that were derived from traditional psychometric studies, typically conducted at a single site and utilizing face-to-face ratings. Our findings suggest that negative symptoms of schizophrenia can validly be measured using the BNSS and PANSS via remote methods.
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Affiliation(s)
- Kazunori Tatsumi
- WCG Clinical, Inc., 212 Carnegie Center, Suite 301, Princeton, NJ 08540, USA.
| | - Alexandra Parfitt
- WCG Clinical, Inc., 212 Carnegie Center, Suite 301, Princeton, NJ 08540, USA
| | - Lisa Weissfeld
- WCG Clinical, Inc., 212 Carnegie Center, Suite 301, Princeton, NJ 08540, USA
| | - Mark Opler
- WCG Clinical, Inc., 212 Carnegie Center, Suite 301, Princeton, NJ 08540, USA
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2
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Luccarelli J, Smith JR, Heckers S, Fricchione G, Wilson JE. The theoretical sensitivity of virtual assessment of catatonia. Schizophr Res 2024; 274:486-488. [PMID: 39515258 DOI: 10.1016/j.schres.2024.10.020] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/03/2024] [Revised: 10/02/2024] [Accepted: 10/27/2024] [Indexed: 11/16/2024]
Affiliation(s)
- James Luccarelli
- Harvard Medical School, Boston, MA, USA; Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA.
| | - Joshua Ryan Smith
- Department of Psychiatry and Behavioral Sciences; Vanderbilt University Medical Center at Village of Vanderbilt, 1500 21st Avenue South, Suite 2200, Nashville, TN 37212, USA; Vanderbilt Kennedy Center, Vanderbilt University; 110 Magnolia Circle, Nashville, TN 37203, USA
| | - Stephan Heckers
- Department of Psychiatry and Behavioral Sciences; Vanderbilt University Medical Center at Village of Vanderbilt, 1500 21st Avenue South, Suite 2200, Nashville, TN 37212, USA
| | - Gregory Fricchione
- Harvard Medical School, Boston, MA, USA; Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA
| | - Jo Ellen Wilson
- Department of Psychiatry and Behavioral Sciences; Vanderbilt University Medical Center at Village of Vanderbilt, 1500 21st Avenue South, Suite 2200, Nashville, TN 37212, USA; Department of Veterans' Affairs Geriatric Research, Education and Clinical Center, Tennessee Valley Healthcare System, Nashville, TN 37212, USA
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Sumiyoshi T, Morio Y, Kawashima T, Tachimori H, Hongo S, Kishimoto T, Watanabe K, Otsubo T, Oi H, Nakagome K, Ishigooka J. Feasibility of remote interviews in assessing disease severity in patients with major depressive disorder: A pilot study. Neuropsychopharmacol Rep 2024; 44:149-157. [PMID: 38267023 PMCID: PMC10932799 DOI: 10.1002/npr2.12411] [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: 09/24/2023] [Revised: 12/01/2023] [Accepted: 12/16/2023] [Indexed: 01/26/2024] Open
Abstract
AIM Interview quality is an important factor in the success of clinical trials for major depressive disorder (MDD). There is a substantial need to establish a reliable, remote clinical assessment interview system that can replace traditional in-person interviews. METHODS We conducted a multicenter, randomized, unblinded, prospective, cross-sectional study to assess the reliability of remote interviews in patients with MDD (UMIN000041839). Eligible patients with MDD underwent remote and in-person sessions of the Montgomery-Åsberg Depression Rating Scale (MADRS) assessment performed by different raters within 28 days of providing consent. Patients were randomized to a group first assessed using in-person interviews and secondarily using remote interviews (in-person-first group) or a group first assessed by remote interviews and secondarily using in-person interviews (remote-first group). Nineteen trained people (15 clinical psychologists, 3 nurses, and 1 clinical laboratory technologist) performed interviews. RESULTS Of 59 patients (in-person-first group, n = 32; remote-first group, n = 27) who completed both remote and in-person interviews, 51% (n = 30) were women; the mean age was 41.6 years (range, 21-64 years). There was a strong association between remote and in-person MADRS scores (r = 0.891, kappa = 0.901). An overall intraclass correlation coefficient (ICC) of 0.886 (95% confidence interval, 0.877-0.952) indicated good consistency between MADRS scores in remote and in-person interviews. The ICC decreased as the severity of depression increased. CONCLUSION Our results suggest remote interviews are a feasible alternative option to in-person interviews in assessing symptom severity in MDD patients and could promote clinical trials in Japan.
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Affiliation(s)
| | | | | | | | | | - Taishiro Kishimoto
- Hills Joint Research Laboratory for Future Preventive Medicine and WellnessKeio University School of MedicineTokyoJapan
- Psychiatry DepartmentDonald and Barbara Zucker School of Medicine at Hofstra/NorthwellHempsteadNew YorkUSA
| | - Koichiro Watanabe
- Department of NeuropsychiatryKyorin University School of MedicineTokyoJapan
| | - Tempei Otsubo
- Department of Psychosomatic & Psychiatric MedicineTokyo Women’s Medical University Adachi Medical CenterTokyoJapan
| | - Hideki Oi
- National Center of Neurology and PsychiatryTokyoJapan
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Harris G, Jones S, Pinkham MB, Lion KM, Ownsworth T. Reliability and validity of the telephone-based version of the Montgomery-Asberg depression rating scale for assessing depression in individuals with primary brain tumour. Disabil Rehabil 2024; 46:1158-1166. [PMID: 37021336 DOI: 10.1080/09638288.2023.2191015] [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: 09/05/2022] [Accepted: 03/09/2023] [Indexed: 04/07/2023]
Abstract
This study aimed to examine interrater reliability and construct validity of the Montgomery-Asberg Depression Rating Scale (MADRS) semi-structured interview for assessing depression in adults with a primary brain tumour. Fifty adults with a primary brain tumour (mean age = 45.86, SD = 12.48) reporting at least mild distress (Distress Thermometer [DT] ≥ 4) were recruited from a multidisciplinary brain tumour clinic and administered a telephone-based cognitive screener, MADRS, Depression Anxiety Stress Scales (DASS) depression subscale and Generalised Anxiety Disorder-7 (GAD-7). Audiotaped interviews were transcribed and then scored by two independent raters. Interrater reliability for the MADRS total score was excellent (ICC = 0.98) and ranged from good to excellent (ICC = 0.83-0.96) for MADRS items. The MADRS total score was significantly associated with the DT, DASS depression, and GAD-7 (r = 0.50-0.76, p < 0.001), thus providing evidence of construct validity. Individuals with poorer cognitive function reported higher levels of depression. The findings provide psychometric support for the MADRS as a semi-structured interview for assessing depression after brain tumour. Further research investigating the sensitivity and specificity of the MADRS is recommended.
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Affiliation(s)
- Georgia Harris
- School of Applied Psychology, Griffith University, Queensland, Australia
- The Hopkins Centre, Menzies Health Institute Queensland, Griffith University, Queensland, Australia
| | - Stephanie Jones
- School of Applied Psychology, Griffith University, Queensland, Australia
| | - Mark B Pinkham
- School of Medicine, University of Queensland, Queensland, Australia
- Department of Radiation Oncology, Princess Alexandra Hospital, Queensland, Australia
| | - Katarzyna M Lion
- The Hopkins Centre, Menzies Health Institute Queensland, Griffith University, Queensland, Australia
| | - Tamara Ownsworth
- School of Applied Psychology, Griffith University, Queensland, Australia
- The Hopkins Centre, Menzies Health Institute Queensland, Griffith University, Queensland, Australia
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5
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Wang L, Chen X, Gu X, De Smedt H, Popova V, Fu DJ, Canuso CM, Drevets WC, Chen G. A Meta-Analysis of the Antidepressant Responses in Pivotal Trials on Esketamine Nasal Spray and Atypical Antipsychotics. Neuropsychiatr Dis Treat 2023; 19:2857-2870. [PMID: 38161513 PMCID: PMC10757775 DOI: 10.2147/ndt.s417027] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/13/2023] [Accepted: 12/15/2023] [Indexed: 01/03/2024] Open
Abstract
Purpose This meta-analysis assessed whether atypical antipsychotics (AAPs) and esketamine nasal spray (ESK-NS), which are mechanistically distinct, differ in antidepressant outcomes. Patients and Methods Data were extracted from 12 trials of ESK-NS or AAPs in depressed patients (4276) with inadequate response or resistance to conventional antidepressants. Montgomery-Åsberg Depression Rating Scale (MADRS) score reductions from baseline and response rates (≥50% reduction) were analyzed. Results At endpoint, the estimated MADRS score reduction of pooled ESK-NS arms was greater than pooled AAP arms (+9.16 points, p < 0.0001). The reduction also was greater in the pooled control arms of the ESK-NS trials than the pooled control arms of the AAP trials (+7.57 points, p < 0.0001). The mean difference in the reductions between pooled ESK-NS and control arms was 1.87 points greater than that between pooled AAP and control arms, but this difference was not significant (95% CI: -4.49, 0.74, p = 0.16). Relative to their respective control arms, the mean difference in response rates was 25% for the pooled ESK-NS and 9% for the pooled AAP arms; the mean response rate was 16% greater in the pooled ESK-NS studies than the pooled AAP studies (p = 0.0004). Comparisons against specific AAPs showed mean differences in the MADRS score reductions at 1 week between the experimental and control arms that were numerically larger in the ESK-NS trials than in the aripiprazole trials (mean difference of 1.71 points, p = 0.06) and the brexpiprazole trials (mean difference of 2.05 points, p = 0.02). Conclusion The ESK-NS arms showed numerically larger MADRS score reductions at week-1 and endpoint, and a significantly larger response rate compared with AAP arms. Prospective studies involving direct comparisons are warranted to compare the relative efficacy between these treatment regimens.
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Affiliation(s)
- Lien Wang
- Janssen Research & Development, LLC, Janssen Pharmaceutical Companies of Johnson & Johnson, Shanghai, People’s Republic of China
- Janssen Research & Development, LLC, Janssen Pharmaceutical Companies of Johnson & Johnson, Brisbane, CA, USA
| | - Xiaowei Chen
- Janssen Research & Development, LLC, Janssen Pharmaceutical Companies of Johnson & Johnson, Shanghai, People’s Republic of China
| | - Xiaojing Gu
- Janssen Research & Development, LLC, Janssen Pharmaceutical Companies of Johnson & Johnson, Shanghai, People’s Republic of China
| | - Heidi De Smedt
- Janssen Research & Development, LLC, Janssen Pharmaceutical Companies of Johnson & Johnson, Beerse, Belgium
| | - Vanina Popova
- Janssen Research & Development, LLC, Janssen Pharmaceutical Companies of Johnson & Johnson, Beerse, Belgium
| | - Dong-Jing Fu
- Janssen Research & Development, LLC, Janssen Pharmaceutical Companies of Johnson & Johnson, Raritan, NJ, USA
| | - Carla M Canuso
- Janssen Research & Development, LLC, Janssen Pharmaceutical Companies of Johnson & Johnson, Raritan, NJ, USA
| | - Wayne C Drevets
- Janssen Research & Development, LLC, Janssen Pharmaceutical Companies of Johnson & Johnson, Brisbane, CA, USA
| | - Guang Chen
- Janssen Research & Development, LLC, Janssen Pharmaceutical Companies of Johnson & Johnson, Brisbane, CA, USA
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Lii TR, Smith AE, Flohr JR, Okada RL, Nyongesa CA, Cianfichi LJ, Hack LM, Schatzberg AF, Heifets BD. Randomized trial of ketamine masked by surgical anesthesia in patients with depression. NATURE MENTAL HEALTH 2023; 1:876-886. [PMID: 38188539 PMCID: PMC10769130 DOI: 10.1038/s44220-023-00140-x] [Citation(s) in RCA: 40] [Impact Index Per Article: 20.0] [Reference Citation Analysis] [Abstract] [Grants] [Track Full Text] [Subscribe] [Scholar Register] [Received: 05/31/2023] [Accepted: 09/14/2023] [Indexed: 01/09/2024]
Abstract
Ketamine may have antidepressant properties, but its acute psychoactive effects complicate successful masking in placebo-controlled trials. We present a single-center, parallel-arm, triple-masked, randomized, placebo-controlled trial assessing the antidepressant efficacy of intravenous ketamine masked by surgical anesthesia (ClinicalTrials.gov, NCT03861988). Forty adult patients with major depressive disorder who were scheduled for routine surgery were randomized to a single infusion of ketamine (0.5 mg/kg) or placebo (saline) during usual anesthesia. All participants, investigators, and direct patient care staff were masked to treatment allocation. The primary outcome was depression severity measured by the Montgomery-Åsberg Depression Rating Scale (MADRS) at 1, 2, and 3 days post-infusion. After all follow-up visits, participants were asked to guess which intervention they received. A mixed-effects model showed no evidence of effect of treatment assignment on the primary outcome (-5.82, 95% CI -13.3 to 1.64, p=0.13). 36.8% of participants guessed their treatment assignment correctly; both groups allocated their guesses in similar proportions. In conclusion, a single dose of intravenous ketamine delivered during surgical anesthesia had no greater effect than placebo in acutely reducing the severity of depressive symptoms in adults with major depressive disorder. This trial successfully masked treatment allocation in moderate-to-severely depressed patients using surgical anesthesia. Although this masking strategy is impractical for most placebo-controlled trials, future studies of novel antidepressants with acute psychoactive effects should make efforts to fully mask treatment assignment in order to minimize subject-expectancy bias.
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Affiliation(s)
- Theresa R Lii
- Department of Anesthesiology, Perioperative and Pain Medicine, Stanford University School of Medicine, Stanford, CA, USA
| | - Ashleigh E Smith
- Department of Anesthesiology, Perioperative and Pain Medicine, Stanford University School of Medicine, Stanford, CA, USA
| | - Josephine R Flohr
- Department of Anesthesiology, Perioperative and Pain Medicine, Stanford University School of Medicine, Stanford, CA, USA
| | - Robin L Okada
- Department of Anesthesiology, Perioperative and Pain Medicine, Stanford University School of Medicine, Stanford, CA, USA
| | - Cynthia A Nyongesa
- Department of Anesthesiology, Perioperative and Pain Medicine, Stanford University School of Medicine, Stanford, CA, USA
| | - Lisa J Cianfichi
- Department of Radiology, Stanford University School of Medicine, Stanford, CA, USA
| | - Laura M Hack
- Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, CA, USA
- Sierra-Pacific Mental Illness Research, Education, and Clinical Center, Veterans Affairs Palo Alto Health Care System, Palo Alto, CA, USA
| | - Alan F Schatzberg
- Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, CA, USA
| | - Boris D Heifets
- Department of Anesthesiology, Perioperative and Pain Medicine, Stanford University School of Medicine, Stanford, CA, USA
- Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, CA, USA
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Donegan CJ, Daldegan-Bueno D, Sumner R, Menkes D, Evans W, Hoeh N, Sundram F, Reynolds L, Ponton R, Cavadino A, Smith T, Roop P, Allen N, Abeysinghe B, Svirskis D, Forsyth A, Bansal M, Muthukumaraswamy S. An open-label pilot trial assessing tolerability and feasibility of LSD microdosing in patients with major depressive disorder (LSDDEP1). Pilot Feasibility Stud 2023; 9:169. [PMID: 37798662 PMCID: PMC10552250 DOI: 10.1186/s40814-023-01399-8] [Citation(s) in RCA: 3] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/29/2023] [Accepted: 09/13/2023] [Indexed: 10/07/2023] Open
Abstract
BACKGROUND Globally, an estimated 260 million people suffer from depression [1], and there is a clear need for the development of new, alternative antidepressant therapies. In light of problems with the tolerability and efficacy of available treatments [2], a global trend is emerging for patients to self-treat depression with microdoses of psychedelic drugs such as lysergic acid diethylamide (LSD) and psilocybin [3]. Beyond anecdotal reports from those who self-medicate in this way, few clinical trials have evaluated this practice. In our recently published phase 1 study in healthy volunteers [4], we determined that LSD microdosing was relatively safe and well tolerated in that cohort. Furthermore, the data demonstrated that conducting such microdosing trials is broadly feasible, with excellent adherence and compliance to the regimen observed. In this open-label pilot trial of patients with major depressive disorder (LSDDEP1), we will test the tolerability and feasibility of an 8-week regimen of LSD microdosing in this patient group prior to a larger subsequent randomised controlled trial (LSDDEP2). METHODS Twenty patients meeting the DSM-5 criteria for major depressive disorder will receive an 8-week LSD microdosing treatment regimen. The treatment protocol will use a sublingual formulation of LSD (MB-22001) delivered twice per week under a titration schedule using a dose of 5-15 µg. Tolerability will be assessed by quantifying the percentage of participants who withdraw from the trial due to adverse events attributable to the treatment regimen, while feasibility will be assessed by quantifying the percentage of attended clinic visits once enrolled. To determine whether there is any antidepressant response to the LSD microdosing regimen, MADRS scores will be assessed at baseline and 2, 4, 6, and 8 weeks after the commencement of the regimen. DISCUSSION The results of LSDDEP1 will provide valuable information regarding the tolerability and feasibility of a proposed LSD microdosing regimen in patients with MDD. Such information is critically important to optimise trial design prior to commencing a subsequent and more resource-intensive randomised controlled trial. TRIAL REGISTRATION ANZCTR, ACTRN12623000486628. Registered on 12 May 2023.
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Affiliation(s)
- Carina Joy Donegan
- Department of Psychological Medicine, Faculty of Medical and Health Sciences, University of Auckland, 2 Park Road, Grafton, Auckland, 1023, New Zealand.
| | - Dimitri Daldegan-Bueno
- School of Pharmacy, Faculty of Medical and Health Sciences, University of Auckland, 85 Park Road, Grafton, Auckland, 1023, New Zealand
| | - Rachael Sumner
- School of Pharmacy, Faculty of Medical and Health Sciences, University of Auckland, 85 Park Road, Grafton, Auckland, 1023, New Zealand
| | - David Menkes
- Department of Psychological Medicine, Faculty of Medical and Health Sciences, Waikato, Clinical Campus, University of Auckland, Pembroke Street, Hamilton, 3240, New Zealand
| | - William Evans
- Mana Health, 7 Ruskin St, Parnell, Auckland, 1052, New Zealand
| | - Nicholas Hoeh
- Department of Psychological Medicine, Faculty of Medical and Health Sciences, University of Auckland, 2 Park Road, Grafton, Auckland, 1023, New Zealand
| | - Frederick Sundram
- Department of Psychological Medicine, Faculty of Medical and Health Sciences, University of Auckland, 2 Park Road, Grafton, Auckland, 1023, New Zealand
| | - Lisa Reynolds
- Department of Psychological Medicine, Faculty of Medical and Health Sciences, University of Auckland, 2 Park Road, Grafton, Auckland, 1023, New Zealand
| | - Rhys Ponton
- School of Pharmacy, Faculty of Medical and Health Sciences, University of Auckland, 85 Park Road, Grafton, Auckland, 1023, New Zealand
| | - Alana Cavadino
- School of Population Health, Faculty of Medical and Health Sciences, University of Auckland, 2 Park Road, Grafton, Auckland, 1023, New Zealand
| | - Todd Smith
- Te Whatu Ora, Auckland, 1023, New Zealand
| | - Partha Roop
- Faculty of Engineering, University of Auckland, Auckland, 1023, New Zealand
| | - Nathan Allen
- Faculty of Engineering, University of Auckland, Auckland, 1023, New Zealand
| | - Binu Abeysinghe
- Faculty of Engineering, University of Auckland, Auckland, 1023, New Zealand
| | - Darren Svirskis
- School of Pharmacy, Faculty of Medical and Health Sciences, University of Auckland, 85 Park Road, Grafton, Auckland, 1023, New Zealand
| | - Anna Forsyth
- School of Pharmacy, Faculty of Medical and Health Sciences, University of Auckland, 85 Park Road, Grafton, Auckland, 1023, New Zealand
| | - Mahima Bansal
- School of Pharmacy, Faculty of Medical and Health Sciences, University of Auckland, 85 Park Road, Grafton, Auckland, 1023, New Zealand
| | - Suresh Muthukumaraswamy
- School of Pharmacy, Faculty of Medical and Health Sciences, University of Auckland, 85 Park Road, Grafton, Auckland, 1023, New Zealand.
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Lii TR, Smith AE, Flohr JR, Okada RL, Nyongesa CA, Cianfichi LJ, Hack LM, Schatzberg AF, Heifets BD. Randomized Trial of Ketamine Masked by Surgical Anesthesia in Depressed Patients. MEDRXIV : THE PREPRINT SERVER FOR HEALTH SCIENCES 2023:2023.04.28.23289210. [PMID: 37205558 PMCID: PMC10187335 DOI: 10.1101/2023.04.28.23289210] [Citation(s) in RCA: 10] [Impact Index Per Article: 5.0] [Reference Citation Analysis] [Abstract] [Grants] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 05/21/2023]
Abstract
BACKGROUND Ketamine may have antidepressant properties, but its acute psychoactive effects complicate successful masking in placebo-controlled trials. METHODS In a triple-masked, randomized, placebo-controlled trial, 40 adult patients with major depressive disorder were randomized to a single infusion of ketamine (0.5 mg/kg) or placebo (saline) during anesthesia as usual for routine surgery. The primary outcome was depression severity measured by the Montgomery-Åsberg Depression Rating Scale (MADRS) at 1, 2, and 3 days post-infusion. The secondary outcome was the proportion of participants with clinical response (≥50% reduction in MADRS scores) at 1, 2, and 3 days post-infusion. After all follow-up visits, participants were asked to guess which intervention they received. RESULTS Mean MADRS scores did not differ between groups at screening or pre-infusion baseline. The mixed-effects model showed no evidence of effect of group assignment on post-infusion MADRS scores at 1 to 3 days post-infusion (-5.82, 95% CI -13.3 to 1.64, p=0.13). Clinical response rates were similar between groups (60% versus 50% on day 1) and comparable to previous studies of ketamine in depressed populations. Secondary and exploratory outcomes did not find statistical separation of ketamine from placebo. 36.8% of participants guessed their treatment assignment correctly; both groups allocated their guesses in similar proportions. One serious adverse event occurred in each group, unrelated to ketamine administration. CONCLUSION In adults with major depressive disorder, a single dose of intravenous ketamine delivered during surgical anesthesia had no greater effect than placebo in acutely reducing the severity of depressive symptoms. This trial successfully masked treatment allocation in moderate-to-severely depressed patients using surgical anesthesia. While it is impractical to use surgical anesthesia for most placebo-controlled trials, future studies of novel antidepressants with acute psychoactive effects should make efforts to fully mask treatment assignment in order to minimize subject-expectancy bias. (ClinicalTrials.gov number, NCT03861988).
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Affiliation(s)
- Theresa R Lii
- Department of Anesthesiology, Perioperative and Pain Medicine (T.R.L., A.E.S., J.F., R.L.O., C.A.N., B.D.H.), the Department of Psychiatry and Behavioral Sciences (L.M.H., A.F.S., B.D.H.), and Department of Radiology (L.J.C.) at Stanford University School of Medicine, Stanford, California; Sierra-Pacific Mental Illness Research, Education, and Clinical Center, Veterans Affairs Palo Alto Health Care System, Palo Alto, California (L.M.H.)
| | - Ashleigh E Smith
- Department of Anesthesiology, Perioperative and Pain Medicine (T.R.L., A.E.S., J.F., R.L.O., C.A.N., B.D.H.), the Department of Psychiatry and Behavioral Sciences (L.M.H., A.F.S., B.D.H.), and Department of Radiology (L.J.C.) at Stanford University School of Medicine, Stanford, California; Sierra-Pacific Mental Illness Research, Education, and Clinical Center, Veterans Affairs Palo Alto Health Care System, Palo Alto, California (L.M.H.)
| | - Josephine R Flohr
- Department of Anesthesiology, Perioperative and Pain Medicine (T.R.L., A.E.S., J.F., R.L.O., C.A.N., B.D.H.), the Department of Psychiatry and Behavioral Sciences (L.M.H., A.F.S., B.D.H.), and Department of Radiology (L.J.C.) at Stanford University School of Medicine, Stanford, California; Sierra-Pacific Mental Illness Research, Education, and Clinical Center, Veterans Affairs Palo Alto Health Care System, Palo Alto, California (L.M.H.)
| | - Robin L Okada
- Department of Anesthesiology, Perioperative and Pain Medicine (T.R.L., A.E.S., J.F., R.L.O., C.A.N., B.D.H.), the Department of Psychiatry and Behavioral Sciences (L.M.H., A.F.S., B.D.H.), and Department of Radiology (L.J.C.) at Stanford University School of Medicine, Stanford, California; Sierra-Pacific Mental Illness Research, Education, and Clinical Center, Veterans Affairs Palo Alto Health Care System, Palo Alto, California (L.M.H.)
| | - Cynthia A Nyongesa
- Department of Anesthesiology, Perioperative and Pain Medicine (T.R.L., A.E.S., J.F., R.L.O., C.A.N., B.D.H.), the Department of Psychiatry and Behavioral Sciences (L.M.H., A.F.S., B.D.H.), and Department of Radiology (L.J.C.) at Stanford University School of Medicine, Stanford, California; Sierra-Pacific Mental Illness Research, Education, and Clinical Center, Veterans Affairs Palo Alto Health Care System, Palo Alto, California (L.M.H.)
| | - Lisa J Cianfichi
- Department of Anesthesiology, Perioperative and Pain Medicine (T.R.L., A.E.S., J.F., R.L.O., C.A.N., B.D.H.), the Department of Psychiatry and Behavioral Sciences (L.M.H., A.F.S., B.D.H.), and Department of Radiology (L.J.C.) at Stanford University School of Medicine, Stanford, California; Sierra-Pacific Mental Illness Research, Education, and Clinical Center, Veterans Affairs Palo Alto Health Care System, Palo Alto, California (L.M.H.)
| | - Laura M Hack
- Department of Anesthesiology, Perioperative and Pain Medicine (T.R.L., A.E.S., J.F., R.L.O., C.A.N., B.D.H.), the Department of Psychiatry and Behavioral Sciences (L.M.H., A.F.S., B.D.H.), and Department of Radiology (L.J.C.) at Stanford University School of Medicine, Stanford, California; Sierra-Pacific Mental Illness Research, Education, and Clinical Center, Veterans Affairs Palo Alto Health Care System, Palo Alto, California (L.M.H.)
| | - Alan F Schatzberg
- Department of Anesthesiology, Perioperative and Pain Medicine (T.R.L., A.E.S., J.F., R.L.O., C.A.N., B.D.H.), the Department of Psychiatry and Behavioral Sciences (L.M.H., A.F.S., B.D.H.), and Department of Radiology (L.J.C.) at Stanford University School of Medicine, Stanford, California; Sierra-Pacific Mental Illness Research, Education, and Clinical Center, Veterans Affairs Palo Alto Health Care System, Palo Alto, California (L.M.H.)
| | - Boris D Heifets
- Department of Anesthesiology, Perioperative and Pain Medicine (T.R.L., A.E.S., J.F., R.L.O., C.A.N., B.D.H.), the Department of Psychiatry and Behavioral Sciences (L.M.H., A.F.S., B.D.H.), and Department of Radiology (L.J.C.) at Stanford University School of Medicine, Stanford, California; Sierra-Pacific Mental Illness Research, Education, and Clinical Center, Veterans Affairs Palo Alto Health Care System, Palo Alto, California (L.M.H.)
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Achtyes ED, Glenn T, Monteith S, Geddes JR, Whybrow PC, Martini J, Bauer M. Telepsychiatry in an Era of Digital Mental Health Startups. Curr Psychiatry Rep 2023; 25:263-272. [PMID: 37166622 PMCID: PMC10172730 DOI: 10.1007/s11920-023-01425-9] [Citation(s) in RCA: 3] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Accepted: 04/18/2023] [Indexed: 05/12/2023]
Abstract
PURPOSE OF REVIEW Telepsychiatry practiced by psychiatrists is evidence-based, regulated, private, and effective in diverse settings. The use of telemedicine has grown since the COVID-19 pandemic as people routinely obtain more healthcare services online. At the same time, there has been a rapid increase in the number of digital mental health startups that offer various services including online therapy and access to prescription medications. These digital mental health firms advertise directly to the consumer primarily through digital advertising. The purpose of this narrative review is to contrast traditional telepsychiatry and the digital mental health market related to online therapy. RECENT FINDINGS In contrast to standard telepsychiatry, most of the digital mental health startups are unregulated, have unproven efficacy, and raise concerns related to self-diagnosis, self-medicating, and inappropriate prescribing. The role of digital mental health firms for people with serious mental illness has not been determined. There are inadequate privacy controls for the digital mental health firms, including for online therapy. We live in an age where there is widespread admiration for technology entrepreneurs and increasing emphasis on the role of the patient as a consumer. Yet, the business practices of digital mental health startups may compromise patient safety for profits. There is a need to address issues with the digital mental health startups and to educate patients about the differences between standard medical care and digital mental health products.
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Affiliation(s)
- Eric D Achtyes
- Western Michigan University Homer Stryker M.D. School of Medicine, Kalamazoo, MI, USA.
| | - Tasha Glenn
- ChronoRecord Association, Fullerton, CA, USA
| | - Scott Monteith
- Michigan State University College of Human Medicine, Traverse City Campus, Traverse City, MI, USA
| | - John R Geddes
- Department of Psychiatry, University of Oxford, Warneford Hospital, Oxford, UK
| | - Peter C Whybrow
- Department of Psychiatry and Biobehavioral Sciences, Semel Institute for Neuroscience and Human Behavior, University of California Los Angeles (UCLA), Los Angeles, CA, USA
| | - Julia Martini
- Department of Psychiatry and Psychotherapy, University Hospital Carl Gustav Carus Medical Faculty, Technische Universität Dresden, Dresden, Germany
| | - Michael Bauer
- Department of Psychiatry and Psychotherapy, University Hospital Carl Gustav Carus Medical Faculty, Technische Universität Dresden, Dresden, Germany
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10
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Kobak K, Shear MK, Skritskaya NA, Bloom C, Bottex G. A Web-Based Therapist Training Tutorial on Prolonged Grief Disorder Therapy: Pre-Post Assessment Study. JMIR MEDICAL EDUCATION 2023; 9:e44246. [PMID: 36972105 PMCID: PMC10131787 DOI: 10.2196/44246] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Subscribe] [Scholar Register] [Received: 11/16/2022] [Revised: 02/07/2023] [Accepted: 02/13/2023] [Indexed: 06/18/2023]
Abstract
BACKGROUND Prolonged grief disorder (PGD) is a newly recognized mental disorder characterized by pervasive intense grief that persists longer than cultural or social expectations and interferes with functioning. The COVID-19 epidemic has resulted in increased rates of PGD, and few clinicians feel confident in treating this condition. PGD therapy (PGDT) is a simple, short-term, and evidence-based treatment developed in tandem with the validation of the PGD diagnosis. To facilitate the dissemination of PGDT training, we developed a web-based therapist tutorial that includes didactic training on PGDT concepts and principles as well as web-based multimedia patient scenarios and examples of clinical implementation of PGDT. OBJECTIVE We aimed to evaluate user satisfaction with the tutorial and whether the tutorial increased trainees' knowledge of PGDT principles and procedures. Moreover, we included a small number of pilot questions to evaluate the PGDT-related clinical skills. METHODS This study evaluated tutorial learning using a pre- and poststudy design. Participants were recruited from professional organization mailing lists, announcements to graduates of the Columbia School of Social Work, and through word of mouth. After signing consent, participants completed a brief demographic survey, a 55-item multiple-choice prestudy test on the concepts and principles of PGD and PGDT covered in the tutorial, and a 4-item pilot web-based prestudy test to gauge PGD clinical implementation skills. The link to the course content was then activated, and participants were given 8 weeks to complete the 11-module tutorial containing information, web-based exercises, simulated patient and video examples, and self-tests. RESULTS Overall, 406 clinicians signed consent, and 236 (58.1%) started the tutorial. Of these, 83.1% (196/236) completed all 11 modules. Trainee scores on our PDGT assessment improved substantially from pretraining to the postmodule assessment, with the total number of correct answers increasing from a mean of 29 (SD 5.5; 52.7% correct) to 36.7 (SD 5.2; 66.7% correct; t195=18.93; P<.001). In addition, the trainee's implementation scores on 4 clinical vignettes increased from 2.6 (SD 0.7) correct out of 4 to 3.1 (SD 0.4) out of 4 (t188=7.02; P<.001). Effect sizes (Cohen d) were 1.44 (95% CI 1.23-1.65) for PDGT assessment and 1.06 (95% CI 0.84-1.29) for implementation. Trainees found the tutorial interesting, enjoyable, clearly presented, and useful for professional development. They endorsed a mean score of 3.7 (SD 0.47) on a 1 to 4 scale of agreement with recommending the course to others and feeling satisfied with the tutorial, and a mean of 3.3 (SD 0.57) with feeling able to apply the skills with clients. CONCLUSIONS This pilot study provides support for the usefulness of this web-based training for teaching clinicians how to administer PGDT. The addition of patient scenarios for clinical implementation strategies holds promise for increasing the effectiveness of PGDT training and other evidence-based treatments. TRIAL REGISTRATION ClinicalTrials.gov NCT05121792; https://www.clinicaltrials.gov/ct2/show/NCT05121792.
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Affiliation(s)
- Kenneth Kobak
- Center for Telepsychology, Madison, WI, United States
| | - M Katherine Shear
- Columbia University School of Social Work, New York, NY, United States
| | | | - Colleen Bloom
- Columbia University School of Social Work, New York, NY, United States
| | - Gaelle Bottex
- Columbia University School of Social Work, New York, NY, United States
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11
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Knyahnytska Y, Zomorrodi R, Kaster T, Voineskos D, Trevizol A, Blumberger D. Neural Correlates of the DEEPP (Anti-suicidal Response to Ketamine in Treatment-Resistant Bipolar Depression) Study: Protocol for a Pilot, Open-Label Clinical Trial. JMIR Res Protoc 2023; 12:e41013. [PMID: 36573651 PMCID: PMC9919457 DOI: 10.2196/41013] [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: 07/12/2022] [Revised: 12/17/2022] [Accepted: 12/27/2022] [Indexed: 12/28/2022] Open
Abstract
BACKGROUND Suicide is among the top 10 leading causes of death worldwide. Of people who died by suicide, the majority are diagnosed with depression. It is estimated that 25%-60% of people with bipolar depression (BD) will attempt suicide at least once, and 10%-15% will die by suicide. Several treatments, such as lithium, clozapine, electroconvulsive therapy, and cognitive behavioral therapy, have been shown to be effective in treating suicidality. However, these treatments can be difficult to tolerate or may take months to take effect. Ketamine, a glutamate N-methyl-D-aspartate antagonist, has been shown to have rapid antisuicidal effect and antidepressant qualities, and is thus a promising intervention to target acute suicidality in patients with BD. However, the biological mechanism underlying its therapeutic action remains poorly understood. Enhancing our understanding of underlying mechanisms of action for ketamine's effectiveness in reducing suicidality is critical to establishing biological markers of treatment response and developing tailored, personalized interventions for patients with BD. OBJECTIVE This is an open-label clinical trial to test the safety and feasibility of repeated ketamine infusions to treat acute suicidality. The primary objective is to test the safety and feasibility of ketamine intervention. The secondary objective is to examine ketamine's potential neurophysiological mechanisms of action by assessing cortical excitation and inhibition to determine potential biomarkers of clinical response. Other objectives are to evaluate the effect of ketamine on acute suicidality and other clinical outcomes, such as depressive symptoms and quality of life, to inform a future larger trial. METHODS This open-label clinical trial aims to test the safety and feasibility of repeated ketamine infusions in patients with BD for suicidality and to assess ketamine's neurophysiological effects. A sterile form of racemic ketamine hydrochloride will be administered over a 40-minute intravenous infusion 2 times per week on nonconsecutive days for 4 weeks (8 sessions). We will recruit 30 adults (24-65 year olds) over 2 years from an academic psychiatric hospital in Toronto, Canada. RESULTS This study is currently ongoing and actively recruiting participants. So far, 5 participants have completed the trial, 1 is currently in active treatment, and 8 participants are on the waitlist to be screened. We anticipate initial results being available in the fall of 2023. This proposal was presented as a poster presentation at the Research to Reality Global Summit on Psychedelic-Assisted Therapies and Medicine, held in May 2022 in Toronto, Canada. CONCLUSIONS Developing effective interventions for acute suicidality in high-risk populations such as those with BD remains a major therapeutic challenge. Ketamine is a promising treatment due to its rapid antidepressant and antisuicidal effects, but its underlying neurophysiological mechanisms of action remain unknown. TRIAL REGISTRATION ClinicalTrials.gov NCT05177146; https://clinicaltrials.gov/ct2/show/NCT05177146. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID) DERR1-10.2196/41013.
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Affiliation(s)
| | - Reza Zomorrodi
- Centre for Addiction and Mental Health, Toronto, ON, Canada
| | - Tyler Kaster
- Centre for Addiction and Mental Health, Toronto, ON, Canada
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Yung HY, Yeung WT, Law CW. The reliability of symptom assessment by telepsychiatry compared with face to face psychiatric interviews. Psychiatry Res 2022; 316:114728. [PMID: 35908348 PMCID: PMC9301901 DOI: 10.1016/j.psychres.2022.114728] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/22/2022] [Revised: 07/10/2022] [Accepted: 07/14/2022] [Indexed: 11/02/2022]
Abstract
INTRODUCTION With the start of the COVID-19 pandemic, the various social distancing policies imposed have mandated psychiatrists to consider the option of using telepsychiatry as an alternative to face-to-face interview in Hong Kong. Limitations over sample size, methodology and information technology were found in previous studies and the reliability of symptoms assessment remained a concern. AIM To evaluate the reliability of assessment of psychiatric symptoms by telepsychiatry comparing with face-to-face psychiatric interview. METHOD This study recruited a sample of adult psychiatric patients in psychiatric wards in Queen Mary Hospital. Semi-structural interviews with the use of standardized psychiatric assessment scales were carried out in telepsychiatry and face-to-face interview respectively by two clinicians and the reliability of psychiatric symptoms elicited were assessed. RESULTS 90 patients completed the assessments The inter-method reliability in Hamilton Depression Rating Scale, Hamilton Anxiety Rating Scale, Columbia Suicide Severity Rating Scale and Brief Psychiatric Rating Scale showed good agreement when compared with face-to-face interview. CONCLUSION Symptoms assessment by telepsychiatry is comparable to assessment conducted by face-to-face interview.
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Affiliation(s)
- Hiu Yan Yung
- Department of Psychiatry, Queen Mary Hospital, 102 Pok Fu Lam Road, Hong Kong.
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13
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Fletcher K, Lindblom K, Seabrook E, Foley F, Murray G. Pilot Testing in the Wild: Feasibility, Acceptability, Usage Patterns, and Efficacy of an Integrated Web and Smartphone Platform for Bipolar II Disorder. JMIR Form Res 2022; 6:e32740. [PMID: 35639462 PMCID: PMC9198820 DOI: 10.2196/32740] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/09/2021] [Revised: 03/25/2022] [Accepted: 03/29/2022] [Indexed: 11/24/2022] Open
Abstract
BACKGROUND Bipolar II disorder (BD-II) is associated with significant burden, disability, and mortality; however, there continues to be a dearth of evidence-based psychological interventions for this condition. Technology-mediated interventions incorporating self-management have untapped potential to help meet this need as an adjunct to usual clinical care. OBJECTIVE The objective of this pilot study is to assess the feasibility, acceptability, and clinical utility of a novel intervention for BD-II (Tailored Recovery-oriented Intervention for Bipolar II Experiences; TRIBE), in which mindfulness-based psychological content is delivered via an integrated web and smartphone platform. The focus of the study is evaluation of the dynamic use patterns emerging from ecological momentary assessment and intervention to assist the real-world application of mindfulness skills learned from web-delivered modules. METHODS An open trial design using pretest and posttest assessments with nested qualitative evaluation was used. Individuals (aged 18-65 years) with a diagnosis of BD-II were recruited worldwide and invited to use a prototype of the TRIBE intervention over a 3-week period. Data were collected via web-based questionnaires and phone interviews at baseline and 3-week follow-up. RESULTS A total of 25 participants completed baseline and follow-up assessments. Adherence rates (daily app use) were 65.6% across the 3-week study, with up to 88% (22/25) of participants using the app synergistically alongside the web-based program. Despite technical challenges with the prototype intervention (from user, hardware, and software standpoints), acceptability was adequate, and most participants rated the intervention positively in terms of concept (companion app with website: 19/25, 76%), content (19/25, 76%), and credibility and utility in supporting their management of bipolar disorder (17/25, 68%). Evaluation using behavioral archetypes identified important use pathways and a provisional model to inform platform refinement. As hypothesized, depression scores significantly decreased after the intervention (Montgomery-Asberg Depression Rating Scale baseline mean 8.60, SD 6.86, vs follow-up mean 6.16, SD 5.11; t24=2.63; P=.01; Cohen d=0.53, 95% CI 0.52-4.36). CONCLUSIONS Our findings suggest that TRIBE is feasible and represents an appropriate and acceptable self-management program for patients with BD-II. Preliminary efficacy results are promising and support full development of TRIBE informed by the present behavioral archetype analysis. Modifications suggested by the pilot study include increasing the duration of the intervention and increasing technical support.
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Affiliation(s)
- Kathryn Fletcher
- Centre for Mental Health, Swinburne University of Technology, Melbourne, Australia
| | - Katrina Lindblom
- Centre for Mental Health, Swinburne University of Technology, Melbourne, Australia
| | - Elizabeth Seabrook
- Centre for Mental Health, Swinburne University of Technology, Melbourne, Australia
| | - Fiona Foley
- Centre for Mental Health, Swinburne University of Technology, Melbourne, Australia
| | - Greg Murray
- Centre for Mental Health, Swinburne University of Technology, Melbourne, Australia
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14
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Wilkinson ST, Rhee TG, Joormann J, Webler R, Ortiz Lopez M, Kitay B, Fasula M, Elder C, Fenton L, Sanacora G. Cognitive Behavioral Therapy to Sustain the Antidepressant Effects of Ketamine in Treatment-Resistant Depression: A Randomized Clinical Trial. PSYCHOTHERAPY AND PSYCHOSOMATICS 2021; 90:318-327. [PMID: 34186531 DOI: 10.1159/000517074] [Citation(s) in RCA: 50] [Impact Index Per Article: 12.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Subscribe] [Scholar Register] [Received: 02/23/2021] [Accepted: 04/22/2021] [Indexed: 11/19/2022]
Abstract
INTRODUCTION Ketamine has emerged as a rapid-acting antidepressant. While ongoing treatment can prevent relapse, concerns exist regarding long-term exposure. OBJECTIVE We conducted a randomized trial to examine the feasibility and efficacy of cognitive behavioral therapy (CBT) following intravenous ketamine in treatment-resistant depression (TRD). METHODS Subjects with TRD were recruited and treated with 6 intravenous infusions of ketamine over 3 weeks. Subjects who experienced a clinical response (≥50% improvement in depression severity) were then randomized to receiving CBT or treatment as usual (TAU) for an additional 14 weeks, using a sequential treatment model. RESULTS Of the 42 patients who signed consent, 28 patients achieved a response and were randomized to CBT or TAU. When measured using the Montgomery-Asberg Depression Rating Scale (primary outcome measure), the effect size at the end of the study was moderate (Cohen d = 0.65; 95% CI -0.55 to 1.82), though the group-by-time interaction effect was not significant. There was a significant group-by-time interaction as measured by the Quick Inventory of Depressive Symptomatology (F = 4.58; p = 0.033), favoring a greater sustained improvement in the CBT group. This corresponded to a moderate-to-large effect size of the Cohen d = 0.71 (95% CI -0.30 to 1.70) at the end of the study (14 weeks following the last ketamine infusion). In a subset of patients (N = 20) who underwent cognitive testing using the emotional N-back assessments before and after ketamine, ketamine responders showed improvement in the accuracy of emotional N-back (t[8] = 2.33; p < 0.05) whereas nonresponders did not (t[10] <1; p ns). CONCLUSIONS This proof-of-concept study provides preliminary data indicating that CBT may sustain the antidepressant effects of ketamine in TRD. Further study and optimization of this treatment approach in well-powered clinical trials is recommended.
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Affiliation(s)
- Samuel T Wilkinson
- Department of Psychiatry, Yale School of Medicine, New Haven, Connecticut, USA.,Interventional Psychiatric Service, Yale School of Medicine, New Haven, Connecticut, USA
| | - Taeho Greg Rhee
- Department of Psychiatry, Yale School of Medicine, New Haven, Connecticut, USA
| | - Jutta Joormann
- Department of Psychology, Yale University, New Haven, Connecticut, USA
| | - Ryan Webler
- Department of Psychology, University of Minnesota, Minneapolis, Minnesota, USA
| | - Mayra Ortiz Lopez
- Department of Nursing, Southern Connecticut State University, New Haven, Connecticut, USA
| | - Brandon Kitay
- Department of Psychiatry, Yale School of Medicine, New Haven, Connecticut, USA.,Department of Psychiatry and Behavioral Sciences, Emory School of Medicine, Atlanta, Georgia, USA
| | - Madonna Fasula
- Department of Psychiatry, Yale School of Medicine, New Haven, Connecticut, USA
| | - Christina Elder
- Department of Psychiatry, Yale School of Medicine, New Haven, Connecticut, USA
| | - Lisa Fenton
- Department of Psychiatry, Yale School of Medicine, New Haven, Connecticut, USA
| | - Gerard Sanacora
- Department of Psychiatry, Yale School of Medicine, New Haven, Connecticut, USA.,Interventional Psychiatric Service, Yale School of Medicine, New Haven, Connecticut, USA
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15
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Barnett P, Goulding L, Casetta C, Jordan H, Sheridan-Rains L, Steare T, Williams J, Wood L, Gaughran F, Johnson S. Implementation of Telemental Health Services Before COVID-19: Rapid Umbrella Review of Systematic Reviews. J Med Internet Res 2021; 23:e26492. [PMID: 34061758 PMCID: PMC8335619 DOI: 10.2196/26492] [Citation(s) in RCA: 68] [Impact Index Per Article: 17.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/14/2020] [Revised: 03/30/2021] [Accepted: 04/30/2021] [Indexed: 02/06/2023] Open
Abstract
BACKGROUND Telemental health care has been rapidly adopted for maintaining services during the COVID-19 pandemic, and a substantial interest is now being devoted in its future role. Service planning and policy making for recovery from the pandemic and beyond should draw on both COVID-19 experiences and the substantial research evidence accumulated before this pandemic. OBJECTIVE We aim to conduct an umbrella review of systematic reviews available on the literature and evidence-based guidance on telemental health, including both qualitative and quantitative literature. METHODS Three databases were searched between January 2010 and August 2020 for systematic reviews meeting the predefined criteria. The retrieved reviews were independently screened, and those meeting the inclusion criteria were synthesized and assessed for risk of bias. Narrative synthesis was used to report these findings. RESULTS In total, 19 systematic reviews met the inclusion criteria. A total of 15 reviews examined clinical effectiveness, 8 reported on the aspects of telemental health implementation, 10 reported on acceptability to service users and clinicians, 2 reported on cost-effectiveness, and 1 reported on guidance. Most reviews were assessed to be of low quality. The findings suggested that video-based communication could be as effective and acceptable as face-to-face formats, at least in the short term. Evidence on the extent of digital exclusion and how it can be overcome and that on some significant contexts, such as children and young people's services and inpatient settings, was found to be lacking. CONCLUSIONS This umbrella review suggests that telemental health has the potential to be an effective and acceptable form of service delivery. However, we found limited evidence on the impact of its large-scale implementation across catchment areas. Combining previous evidence and COVID-19 experiences may allow realistic planning for the future implementation of telemental health.
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Affiliation(s)
- Phoebe Barnett
- Centre for Outcomes Research and Effectiveness, Division of Psychology and Language Sciences, University College London, London, United Kingdom
- NIHR Mental Health Policy Research Unit, Division of Psychiatry, University College London, London, United Kingdom
| | - Lucy Goulding
- King's Improvement Science, Centre for Implementation Science, King's College London, London, United Kingdom
| | - Cecilia Casetta
- NIHR Applied Research Collaboration, King's College London, London, United Kingdom
| | - Harriet Jordan
- NIHR Applied Research Collaboration, King's College London, London, United Kingdom
- Institute of Psychiatry, Psychology and Neuroscience, King's College London and South London and Maudsley NHS Trust, London, United Kingdom
| | - Luke Sheridan-Rains
- NIHR Mental Health Policy Research Unit, Division of Psychiatry, University College London, London, United Kingdom
| | - Thomas Steare
- NIHR Mental Health Policy Research Unit, Division of Psychiatry, University College London, London, United Kingdom
| | - Julie Williams
- Centre for Implementation Science, Health Service and Population Research Department, King's College London, London, United Kingdom
| | - Lisa Wood
- Division of Psychiatry, University College London, London, United Kingdom
| | - Fiona Gaughran
- NIHR Applied Research Collaboration, King's College London, London, United Kingdom
- Institute of Psychiatry, Psychology and Neuroscience, King's College London and South London and Maudsley NHS Trust, London, United Kingdom
| | - Sonia Johnson
- NIHR Mental Health Policy Research Unit, Division of Psychiatry, University College London, London, United Kingdom
- Camden and Islington NHS Foundation Trust, London, United Kingdom
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16
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Siegel JS, Palanca BJA, Ances BM, Kharasch ED, Schweiger JA, Yingling MD, Snyder AZ, Nicol GE, Lenze EJ, Farber NB. Prolonged ketamine infusion modulates limbic connectivity and induces sustained remission of treatment-resistant depression. Psychopharmacology (Berl) 2021; 238:1157-1169. [PMID: 33483802 PMCID: PMC7969576 DOI: 10.1007/s00213-021-05762-6] [Citation(s) in RCA: 15] [Impact Index Per Article: 3.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/13/2020] [Accepted: 01/06/2021] [Indexed: 12/11/2022]
Abstract
Ketamine produces a rapid antidepressant response in over 50% of adults with treatment-resistant depression. A long infusion of ketamine may provide durable remission of depressive symptoms, but the safety, efficacy, and neurobiological correlates are unknown. In this open-label, proof-of-principle study, adults with treatment-resistant depression (N = 23) underwent a 96-h infusion of intravenous ketamine (0.15 mg/kg/h titrated toward 0.6 mg/kg/h). Clonidine was co-administered to reduce psychotomimetic effects. We measured clinical response for 8 weeks post-infusion. Resting-state functional magnetic resonance imaging was used to assess functional connectivity in patients pre- and 2 weeks post-infusion and in matched non-depressed controls (N = 27). We hypothesized that responders to therapy would demonstrate response-dependent connectivity changes while all subjects would show treatment-dependent connectivity changes. Most participants completed infusion (21/23; mean final dose 0.54 mg/kg/h, SD 0.13). The infusion was well tolerated with minimal cognitive and psychotomimetic side effects. Depressive symptoms were markedly reduced (MADRS 29 ± 4 at baseline to 9 ± 8 one day post-infusion), which was sustained at 2 weeks (13 ± 8) and 8 weeks (15 ± 8). Imaging demonstrated a response-dependent decrease in hyperconnectivity of the subgenual anterior cingulate cortex to the default mode network, and a treatment-dependent decrease in hyperconnectivity within the limbic system (hippocampus, amygdala, medial thalamus, nucleus accumbens). In exploratory analyses, connectivity was increased between the limbic system and frontal areas, and smaller right hippocampus volume at baseline predicted larger MADRS change. A single prolonged infusion of ketamine provides a tolerated, rapid, and sustained response in treatment-resistant depression and normalizes depression-related hyperconnectivity in the limbic system and frontal lobe. ClinicalTrials.gov : Treatment Resistant Depression (Pilot), NCT01179009.
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Affiliation(s)
- Joshua S Siegel
- Department of Psychiatry, Washington University School of Medicine, 660 S. Euclid, Box 8134, St. Louis, MO, 63110, USA.
| | - Ben J A Palanca
- Department of Anesthesiology, Washington University School of Medicine, St. Louis, MO, USA
| | - Beau M Ances
- Department of Neurology, Washington University School of Medicine, St. Louis, MO, USA
| | | | - Julie A Schweiger
- Department of Psychiatry, Washington University School of Medicine, 660 S. Euclid, Box 8134, St. Louis, MO, 63110, USA
| | - Michael D Yingling
- Department of Psychiatry, Washington University School of Medicine, 660 S. Euclid, Box 8134, St. Louis, MO, 63110, USA
| | - Abraham Z Snyder
- Department of Neurology, Washington University School of Medicine, St. Louis, MO, USA.,Department of Radiology, Washington University School of Medicine, St. Louis, MO, USA
| | - Ginger E Nicol
- Department of Psychiatry, Washington University School of Medicine, 660 S. Euclid, Box 8134, St. Louis, MO, 63110, USA
| | - Eric J Lenze
- Department of Psychiatry, Washington University School of Medicine, 660 S. Euclid, Box 8134, St. Louis, MO, 63110, USA
| | - Nuri B Farber
- Department of Psychiatry, Washington University School of Medicine, 660 S. Euclid, Box 8134, St. Louis, MO, 63110, USA
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17
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Fowler JC, Skubiak T, Engelhardt K, Furst B, Zhao S, Nyilas M, Profit D, Carson W. Feasibility of a Noninterventional Decentralized Clinical Trial Model in Adults with Major Depressive Disorder. JOURNAL OF SCIENTIFIC INNOVATION IN MEDICINE 2021. [DOI: 10.29024/jsim.84] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/17/2022] Open
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18
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Batastini AB, Paprzycki P, Jones ACT, MacLean N. Are videoconferenced mental and behavioral health services just as good as in-person? A meta-analysis of a fast-growing practice. Clin Psychol Rev 2020; 83:101944. [PMID: 33227560 DOI: 10.1016/j.cpr.2020.101944] [Citation(s) in RCA: 78] [Impact Index Per Article: 15.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/30/2020] [Revised: 10/19/2020] [Accepted: 11/02/2020] [Indexed: 12/11/2022]
Abstract
The use of videoconferencing technologies (VCT) is on the rise given its potential to close the gap between mental health care need and availability. Yet, little is known about the effectiveness of these services compared to those delivered in-person. A series of meta-analyses were conducted using 57 empirical studies (43 examining intervention outcomes; 14 examining assessment reliability) published over the past two decades that included a variety of populations and clinical settings. Using conventional and HLM3 meta-analytical approaches, VCT consistently produced treatment effects that were largely equivalent to in-person delivered interventions across 281 individual outcomes and 4336 clients, with female clients and those treated in medical facilities tending to respond more favorably to VCT than in-person. Results of an HLM3 model suggested assessments conducted using VCT did not appear to lead to differential decisions compared to those conducted in-person across 83 individual outcomes and 332 clients/examinees. Although aggregate findings support the use of VCT as a viable alternative to in-person service delivery of mental healthcare, several limitations in the current literature base were revealed. Most concerning was the relatively limited number of randomized controlled trials and the inconsistent (and often incomplete) reporting of methodological features and results. Recommendations for reporting the findings of telemental health research are provided.
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Affiliation(s)
- Ashley B Batastini
- University of Southern Mississippi, USA; University of Mississippi Medical Center Department of Psychiatry, USA.
| | - Peter Paprzycki
- University of Southern Mississippi, USA; Mississippi Center for Clinical and Translational Research, USA; University of Toledo, USA
| | | | - Nina MacLean
- Michigan Department of Health & Human Services - Center for Forensic Psychiatry, USA
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19
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Abstract
The utilization of telemedicine and telepsychiatry (TP) services in the outpatient department (OPD) has been increasing in recent years. The information about the technological, administrative, and clinical challenges is being addressed by the telemedicine and TP guidelines published by several individual nations. TP aims to address the treatment gaps, barriers for utilization, accessibility, diagnostic validity, financial implications, and individual client preferences. Utilization of TP in the OPD varies from country to country depending upon their healthcare delivery systems. It also varies in populations utilizing the TP services-urban, rural, child and adolescent, geriatric, and differently abled. TP services in the OPDs are being incorporated differentially by government organizations, insurance recognized psychiatric healthcare organizations, private psychiatric group practice deliverers, and individual, standalone psychiatric healthcare deliverers. TP may not replace the traditional in-person consultations completely. Covid-19 pandemic has hastened its utilization across several healthcare delivery systems. Healthcare organizations, clinicians, other healthcare deliverers, and end users are in the process of adapting to the new scenario. Incorporation of the big data, machine learning, artificial intelligence, virtual reality, and other technological advances in the psychiatric healthcare delivery systems into TP services in the OPDs would significantly contribute to the overall quality and efficacy of the psychiatric healthcare delivery systems in the future.
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Affiliation(s)
| | | | - Amala Emani
- Columbus Hospital, Hyderabad, Telangana, India
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Christensen LF, Moller AM, Hansen JP, Nielsen CT, Gildberg FA. Patients' and providers' experiences with video consultations used in the treatment of older patients with unipolar depression: A systematic review. J Psychiatr Ment Health Nurs 2020; 27:258-271. [PMID: 31677331 DOI: 10.1111/jpm.12574] [Citation(s) in RCA: 35] [Impact Index Per Article: 7.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/10/2019] [Revised: 10/23/2019] [Accepted: 10/30/2019] [Indexed: 12/11/2022]
Abstract
WHAT IS KNOWN ON THE SUBJECT?: Depression is the most common cause of mental illness amongst older people. As a result of the growth of the older population, it is expected that an increasing number of older people will need treatment. Depression can be effectively treated-but fewer than half of those who are affected receive treatment. Barriers to receiving treatment are lack of resources and trained healthcare providers, social stigma, incorrect diagnoses and long distances to treatment facilities. There is an increased need for alternative ways of treating patients with depression. The use of video consultations has shown to be a viable option for delivering mental health care to older patients. Use of video consultations allows patients to receive treatment in their own homes. None of the existing reviews have focused on satisfaction with the use of video consultations amongst older people with depression. This paper provides knowledge regarding the use of video consultations, especially for older people with depression. WHAT THIS PAPER ADDS TO EXISTING KNOWLEDGE?: No previous review has sought to understand the use of video consultations in mental health care to older patients with depression. The results show that video consultations support mental health practice, especially as a useful alternative when face-to-face therapy is not possible. An initial scepticism from participants quickly disappeared when video consultations were experienced in action. The challenges associated with the use of video consultations seem to consist of technical problems and lack of support from staff. WHAT ARE THE IMPLICATIONS FOR PRACTICE?: Mental health practitioners should consider the use of video consultations because it can support mental health practice, especially as a useful alternative when face-to-face therapy is not possible. ABSTRACT: Introduction Depression is the leading cause of mental illness amongst an ageing population and fewer than half of those who are affected receive treatment. There is an increased need for alternative ways of treating patients; the use of video consultations has been shown to be a viable option for delivering mental health care. However, none of the existing reviews have focused on satisfaction with the use of video consultations amongst older people with depression and providers. Aim To conduct a systematic review of the existing literature focusing on patients' and providers' experiences of video consultations for depression. Method Eight scientific databases were searched. In all, 3,537 articles were identified and, of these, 21 peer-reviewed articles were included in this review. Results The results show that video consultations support mental health practice, especially as a useful alternative when face-to-face therapy is not possible. Any initial scepticism quickly disappeared when video consultations were experienced in action. The challenges seem to consist of technical problems and lack of support from staff. Discussion The experiences and satisfaction of older people with depression seem to be positive, although methodological limitations and deficiencies of the reviewed articles should be considered. More qualitative research is needed, and future studies should focus on specific diagnoses and providers' experiences. Implications for practice Video consultations support mental health practice, especially as a useful alternative when face-to-face therapy is not possible.
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Affiliation(s)
- Lone Fisker Christensen
- Department of Regional Health Research, Faculty of Health Sciences, University of Southern Denmark, Odense, Denmark.,Research Unit for Telepsychiatry and E-mental Health, University of Southern Denmark, Odense, Denmark.,Research Unit, Department of Mental Health, Esbjerg, Region of Southern Denmark, Esbjerg, Denmark
| | - Anne Marie Moller
- Research Unit for Telepsychiatry and E-mental Health, University of Southern Denmark, Odense, Denmark.,Health Promotion Research, Department of Public Health, University of Southern Denmark, Odense, Denmark
| | - Jens Peter Hansen
- Research Unit, Department of Mental Health, Esbjerg, Region of Southern Denmark, Esbjerg, Denmark.,Center for Psychiatric Nursing and Health Research, Department of Regional Health Research, Faculty of Health Sciences, University of Southern Denmark, Odense, Denmark
| | - Connie Thuroe Nielsen
- Department of Regional Health Research, Faculty of Health Sciences, University of Southern Denmark, Odense, Denmark.,Department of Mental Health, Vejle, Region of Southern Denmark, Vejle, Denmark
| | - Frederik Alkier Gildberg
- Center for Psychiatric Nursing and Health Research, Department of Regional Health Research, Faculty of Health Sciences, University of Southern Denmark, Odense, Denmark
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Lopresti AL, Smith SJ, Hood SD, Drummond PD. Efficacy of a standardised saffron extract (affron®) as an add-on to antidepressant medication for the treatment of persistent depressive symptoms in adults: A randomised, double-blind, placebo-controlled study. J Psychopharmacol 2019; 33:1415-1427. [PMID: 31475623 DOI: 10.1177/0269881119867703] [Citation(s) in RCA: 20] [Impact Index Per Article: 3.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/14/2022]
Abstract
BACKGROUND As a stand-alone intervention, saffron has efficacy for the treatment of mild-to-moderate depression. However, research as an adjunct agent is limited. AIMS The effects of saffron as an adjunct to pharmaceutical antidepressants in adults with persistent depression was investigated. METHODS In this eight-week, randomised, double-blind, placebo-controlled study, adults with persistent depression, currently taking a pharmaceutical antidepressant were given a placebo or a saffron extract (affron®, 14 mg b.i.d.). Primary outcome measures included the clinician-rated Montgomery-Åsberg Depression Rating Scale (MADRS) and self-rated MADRS (MADRS-S). Secondary outcome measures included the Antidepressant Side-Effect Checklist (ASEC) and Short Form-36 Health Survey (SF-36). RESULTS Of the 160 participants enrolled, 139 provided usable data. Based on the MADRS, depressive symptoms decreased more in participants taking saffron compared with a placebo, with reductions of 41 and 21%, respectively (p = 0.001). However, scores on the MADRS-S decreased 27 and 26% in the saffron and placebo conditions, respectively (p = 0.831). Saffron was associated with a greater reduction in adverse effects of antidepressants (p = 0.019), although this was non-significant after covarying for baseline values (p = 0.449). Quality of life improved in both groups with no significant between-group differences (p = 0.638). CONCLUSION Adjunctive administration of a standardised saffron extract (affron®) for eight weeks was associated with a greater improvement in depressive symptoms as measured by the clinician-rated MADRS but not the self-report MADRS-S. Given the conflicting results, further research is needed to clarify the clinical benefits of saffron as an adjunctive treatment for adults with persistent depressive symptoms despite antidepressant drug treatment.
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Affiliation(s)
- Adrian L Lopresti
- College of Science, Health, Engineering and Education, Murdoch University, Perth, WA, Australia.,Clinical Research Australia, Perth, WA, Australia
| | - Stephen J Smith
- College of Science, Health, Engineering and Education, Murdoch University, Perth, WA, Australia.,Clinical Research Australia, Perth, WA, Australia
| | - Sean D Hood
- Division of Psychiatry, UWA Medical School, University of Western Australia, Perth, WA, Australia
| | - Peter D Drummond
- College of Science, Health, Engineering and Education, Murdoch University, Perth, WA, Australia
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Fletcher K, Yang Y, Johnson SL, Berk M, Perich T, Cotton S, Jones S, Lapsley S, Michalak E, Murray G. Buffering against maladaptive perfectionism in bipolar disorder: The role of self-compassion. J Affect Disord 2019; 250:132-139. [PMID: 30852365 DOI: 10.1016/j.jad.2019.03.003] [Citation(s) in RCA: 15] [Impact Index Per Article: 2.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/24/2018] [Revised: 02/12/2019] [Accepted: 03/03/2019] [Indexed: 01/18/2023]
Abstract
BACKGROUND Maladaptive perfectionism is a transdiagnostic risk and maintaining factor for a range of mental health conditions, including bipolar disorder (BD). Self-compassion represents a potential protective factor against maladaptive perfectionism, however no studies to date have examined the relationship of these constructs in BD. The aim of the present study was to examine associations between maladaptive perfectionism, self-compassion and symptoms among individuals with BD. METHODS Baseline data were collected from 302 participants with a DSM-IV diagnosis of BD participating in an international randomised controlled trial. Participants completed measures of maladaptive perfectionism, self-compassion, symptom severity and emotion regulation difficulties. Clinician-administered measures of depression and mania severity were additionally collected. Correlation and mediation analyses were conducted. RESULTS Maladaptive perfectionism was positively associated with depression, anxiety and emotion regulation difficulties. Lower levels of self-compassion correlated with greater self-reported depression, anxiety and emotion regulation difficulties. Self-compassion partially mediated relationships between maladaptive perfectionism, depression, anxiety and emotion regulation difficulties. LIMITATIONS The cross-sectional design limits conclusions about causal relationships between study variables. Results may not be generalizable to other BD populations. The role of maladaptive perfectionism and self-compassion in elevated mood states of BD remains unclear. CONCLUSION Self-compassion represents one mechanism through which maladaptive perfectionism influences symptoms of depression, anxiety and emotion regulation difficulties in BD. Self-compassion represents a modifiable treatment target; individuals with BD exhibiting maladaptive perfectionistic tendencies may benefit from interventions fostering self-compassion.
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Affiliation(s)
- Kathryn Fletcher
- Centre for Mental Health, Swinburne University, Melbourne, Australia.
| | - Yan Yang
- Centre for Mental Health, Swinburne University, Melbourne, Australia
| | | | - Michael Berk
- IMPACT Strategic Research Centre, School of Medicine, Deakin University, Barwon Health, Geelong, Australia; Department of Psychiatry, University of Melbourne, Melbourne, Australia; Orygen, the National Centre of Excellence in Youth Mental Health, Parkville, Australia; Centre for Youth Mental Health, University of Melbourne, Melbourne, Australia; Florey Institute for Neuroscience and Mental Health, Melbourne, Australia
| | - Tania Perich
- Western Sydney University, Sydney, Australia; School of Psychiatry, University of New South Wales, Sydney, Australia
| | - Sue Cotton
- Orygen, the National Centre of Excellence in Youth Mental Health, Parkville, Australia; Centre for Youth Mental Health, University of Melbourne, Melbourne, Australia
| | - Steven Jones
- Spectrum Centre for Mental Health Research, Faculty of Health and Medicine, Lancaster University, Lancaster, UK
| | - Sara Lapsley
- Department of Psychiatry, University of British Columbia, Vancouver, Canada
| | - Erin Michalak
- Department of Psychiatry, University of British Columbia, Vancouver, Canada
| | - Greg Murray
- Centre for Mental Health, Swinburne University, Melbourne, Australia
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Targum SD, Catania CJ. Audio-digital recordings for surveillance in clinical trials of major depressive disorder. Contemp Clin Trials Commun 2019; 14:100317. [PMID: 30705991 PMCID: PMC6348193 DOI: 10.1016/j.conctc.2019.100317] [Citation(s) in RCA: 7] [Impact Index Per Article: 1.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/15/2018] [Revised: 12/17/2018] [Accepted: 01/04/2019] [Indexed: 01/18/2023] Open
Abstract
Ratings surveillance is used in clinical trials to assure ratings reliability of site-based scores. One surveillance method employs audio-digital recordings of site-based clinician interviews to obtain remote, site-independent scores for assessment of paired scoring concordance and interview quality. We examined the utility of this surveillance strategy using paired site-independent scores derived from recorded site-based Montgomery-Asberg depression rating scale (MADRS) interviews obtained from patients with major depressive disorder (MDD) participating in 5 clinical trials. High correlations were noted between the 3736 paired site-based and site-independent scores across all visits. Some rater “outliers” were identified whose ratings performance improved following remediation. In 3 studies with available outcome data, the blinded remote ratings yielded a high predictive value (91.2%) for replicating treatment response rates. The magnitude of the total MADRS scores affected the directionality of paired scoring deviations in each of the 5 studies. Across all visits, site-based raters scored the more severe MADRS scores (≥30) higher than site-independent raters and the less severe MADRS scores (<20) lower than site-independent raters. Individual MADRS items were similarly affected by the directionality of symptom severity. This analysis affirms the utility of audio-digital recording of site-based interviews as a surveillance strategy for quality assurance (monitoring and remediation). In addition, the high predictive value of blinded remote ratings to replicate site-based treatment outcomes may be useful to affirm primary site-based results when there is a potential of functional unblinding. The use of remote ratings as a primary measure beyond its utility for quality assurance needs further exploration.
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Affiliation(s)
- Steven D Targum
- Bracket Global, 2 Oliver Street, Suite 1003, Boston, MA, 02109, USA
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Videoconference compared to telephone in healthcare delivery: A systematic review. Int J Med Inform 2018; 118:44-53. [DOI: 10.1016/j.ijmedinf.2018.07.007] [Citation(s) in RCA: 151] [Impact Index Per Article: 21.6] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/12/2018] [Revised: 07/18/2018] [Accepted: 07/24/2018] [Indexed: 01/18/2023]
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Validation of the Arabic version of the MADRS scale among Lebanese patients with depression. Encephale 2018; 45:195-199. [PMID: 30122299 DOI: 10.1016/j.encep.2018.05.004] [Citation(s) in RCA: 9] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/07/2017] [Revised: 05/17/2018] [Accepted: 05/18/2018] [Indexed: 12/26/2022]
Abstract
AIM To use the Arabic version of the MADRS in Lebanese depressed patients, check its validity and reproducibility compared to other versions of the questionnaire and assess risk factors affecting the total MADRS score. METHODS This case-control study, performed between September 2016 and January 2017, included 200 patients (100 patients, 100 controls). The questionnaire included two parts, the first one concerning the socio-demographic characteristics another one that included the Montgomery-Asberg Depression Rating Scale (MADRS) questions, which was translated from English to Arabic through an initial translation and back translation process. RESULTS The MADRS scale items converged over a solution of one factor that had an Eigenvalue over 1, explaining a total of 83.90% of the variance. A Kaiser-Meyer-Olkin measure of sampling adequacy of 0.953 was found, with a significant Bartlett's test of sphericity (P<0.001). A stepwise linear regression, using the total MADRS score as continuous variable, showed that a university level of education would significantly decrease the total MADRS score by 20 points (beta=-20.02, CI: from -26.337 to -13.709, P<0.001). Unemployment was significantly more associated with an increase in the total MADRS score level by 10.23 points (beta=10.23, CI: 3.944-16.526, P=0.002). CONCLUSION This study shows that the Arabic version of the MADRS has promising psychometric properties, and thus it is a good tool to use for the diagnosis of patients with depression. Based on this study, health care professionals and researchers can readily use the MADRS questionnaire to estimate the overall severity of depression among psychiatric patients in Lebanon.
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Reliability of Videoconferencing Administration of a Communication Questionnaire to People With Traumatic Brain Injury and Their Close Others. J Head Trauma Rehabil 2017; 32:E38-E44. [DOI: 10.1097/htr.0000000000000282] [Citation(s) in RCA: 9] [Impact Index Per Article: 1.1] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/25/2022]
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Richards C, McIntyre RS, Weisler R, Sambunaris A, Brawman-Mintzer O, Gao J, Geibel B, Dauphin M, Madhoo M. Lisdexamfetamine dimesylate augmentation for adults with major depressive disorder and inadequate response to antidepressant monotherapy: Results from 2 phase 3, multicenter, randomized, double-blind, placebo-controlled studies. J Affect Disord 2016; 206:151-160. [PMID: 27474961 DOI: 10.1016/j.jad.2016.07.006] [Citation(s) in RCA: 12] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/09/2016] [Revised: 06/14/2016] [Accepted: 07/03/2016] [Indexed: 12/13/2022]
Abstract
BACKGROUND The efficacy, safety, and tolerability of lisdexamfetamine dimesylate (LDX) augmentation of antidepressant monotherapy in adults with major depressive disorder (MDD) from two phase 3 studies are reported. METHODS Across study 1 (placebo, n=201; LDX, n=201) and study 2 (placebo, n=213; LDX, n=211), most participants (placebo and LDX) in the safety analysis set were female (study 1: 66.2% and 64.2%; study 2: 67.1% and 66.8%); mean±SD ages were 41.8±12.04 with placebo and 42.2±12.32 with LDX in study 1 and 42.6±11.41 with placebo and 42.0±11.63 with LDX in study 2. Participants (18-65 y) had DSM-IV-TR-diagnosed MDD and lead-in baseline Montgomery-Åsberg Depression Rating Scale (MADRS) total scores ≥24. Eight-week antidepressant lead-in phases prospectively assessed antidepressant response. Then, 8 weeks of randomized (1:1), double-blind treatment with dose-optimized LDX (20-70mg) or placebo in participants exhibiting inadequate antidepressant monotherapy responses (augmentation baseline MADRS total scores ≥18 and <50% MADRS total score reductions from lead-in baseline to augmentation baseline) was initiated. The primary endpoint was MADRS total score change from augmentation baseline to week 16. Safety and tolerability measures included the occurrence of treatment-emergent adverse events (TEAEs). RESULTS Least squares mean (95% CI) treatment differences (LDX-placebo) for MADRS total score changes from augmentation baseline to week 16 were not statistically significant in study 1 (0.1 [-1.7, 2.0], P=0.883) or study 2 (-0.5 [-2.3, 1.3], P=0.583). The only TEAE reported by >5% of LDX participants at twice the placebo rate in both studies was dry mouth. LIMITATIONS Limitations include the exclusion of participants with psychiatric comorbidities/active medical disorders, the inability to assess specific MDD symptom domains (eg, anhedonia, cognition) or subtypes, the use of telephone-based depression assessments, and the potential influence of placebo response. CONCLUSION Contrary to expectations, LDX augmentation was not superior to placebo in reducing depressive symptoms in individuals with MDD exhibiting inadequate responses to antidepressant monotherapy.
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Affiliation(s)
| | | | - Richard Weisler
- Duke University Medical Center, Durham, and the University of North Carolina at Chapel Hill, Chapel Hill, NC, USA
| | | | - Olga Brawman-Mintzer
- Medical University of South Carolina and Ralph H. Johnson VA Medical Center, Charleston, SC, USA
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Hubley S, Lynch SB, Schneck C, Thomas M, Shore J. Review of key telepsychiatry outcomes. World J Psychiatry 2016; 6:269-82. [PMID: 27354970 PMCID: PMC4919267 DOI: 10.5498/wjp.v6.i2.269] [Citation(s) in RCA: 308] [Impact Index Per Article: 34.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/28/2015] [Revised: 01/27/2016] [Accepted: 03/14/2016] [Indexed: 02/05/2023] Open
Abstract
AIM To conduct a review of the telepsychiatry literature. METHODS We conducted a systematic search of the literature on telepsychiatry using the search terms, "telepsychiatry", "telemental health", "telecare", "telemedicine", "e-health", and "videoconferencing". To meet criteria for inclusion, studies had to: (1) be published in a peer-reviewed journal after the year 2000; (2) be written in English; (3) use videoconferencing technology for the provision of mental health assessment or treatment services; and (4) use an adequately-powered randomized controlled trial design in the case of treatment outcome studies. Out of 1976 studies identified by searches in PubMed (Medline database), Ovid medline, PsychInfo, Embase, and EBSCO PSYCH, 452 met inclusion criteria. Studies that met all inclusion criteria were organized into one of six categories: (1) satisfaction; (2) reliability; (3) treatment outcomes; (4) implementation outcomes; (5) cost effectiveness; and (6) and legal issues. All disagreements were resolved by reassessing study characteristics and discussion. RESULTS Overall, patients and providers are generally satisfied with telepsychiatry services. Providers, however, tend to express more concerns about the potentially adverse of effects of telepsychiatry on therapeutic rapport. Patients are less likely to endorse such concerns about impaired rapport with their provider. Although few studies appropriately employ non-inferiority designs, the evidence taken together suggests that telepsychiatry is comparable to face-to-face services in terms of reliability of clinical assessments and treatment outcomes. When non-inferiority designs were appropriately used, telepsychiatry performed as well as, if not better than face-to-face delivery of mental health services. Studies using both rudimentary and more sophisticated methods for evaluating cost-effectiveness indicate that telepsychiatry is not more expensive than face-to-face delivery of mental health services and that telepsychiatry is actually more cost-effective in the majority of studies reviewed. Notwithstanding legal concerns about loss of confidentiality and limited capacity to respond to psychiatric emergencies, we uncovered no published reports of these adverse events in the use of telepsychiatry. CONCLUSION A large evidence base supports telepsychiatry as a delivery method for mental health services. Future studies will inform optimal approaches to implementing and sustaining telepsychiatry services.
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Abstract
Lack of standardization across sites and raters, poor interrater reliability, and possible scoring bias affecting the primary outcome measure contribute to a high failure rate in anxiety trials. Remote centralized raters who are blinded to protocol inclusion and exclusion criteria as well as visit number may standardize assessments across raters and eliminate scoring bias, decreasing placebo response and thereby increasing signal detection. The purpose of the primary study was to test the safety and efficacy of an anxiolytic in a double-blind, placebo-controlled (no active comparator), multicenter trial. However, there was an additional prospective objective to explore site ratings compared with remote centralized ratings in the cohort of subjects on placebo. Site raters assessed subjects 6 times over an 8-week period. The primary outcome measure was the week 8 site-rated Hamilton Anxiety Scale (HAM-A). Remote centralized raters by telephone independently rated these subjects on the HAM-A at baseline and week 6. Of the 122 subjects selected by site raters and therefore randomized, remote centralized raters would have admitted 59 (48%) and excluded 63 (52%), based on their HAM-A ratings. The mean change from baseline in HAM-A total score in the placebo group admitted to the study by site raters was 9.3, significantly higher than the 5.9 point mean change on placebo as measured by the remote centralized raters.The data are consistent with the potential for qualification bias at baseline when rated by sites. The results make a strong case for using strategies to ensure that baseline scoring is truly independent of the pressure to enroll.
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Chakrabarti S. Usefulness of telepsychiatry: A critical evaluation of videoconferencing-based approaches. World J Psychiatry 2015; 5:286-304. [PMID: 26425443 PMCID: PMC4582305 DOI: 10.5498/wjp.v5.i3.286] [Citation(s) in RCA: 176] [Impact Index Per Article: 17.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/21/2014] [Revised: 05/07/2015] [Accepted: 06/09/2015] [Indexed: 02/05/2023] Open
Abstract
Telepsychiatry, i.e., the use of information and communication technologies to provide psychiatric services from a distance, has been around for more than half a century now. Research over this period has shown that videoconferencing-based telepsychiatry is an enabling and empowering form of service delivery, which promotes equality of access, and high levels of satisfaction among patients. The range of services offered by videoconferencing-based telepsychiatry, potential users and points of delivery of such services are theoretically limitless. Telepsychiatry has both clinical utility and non-clinical uses such as administrative, learning and research applications. A large body of accumulated evidence indicates that videoconferencing-based telepsychiatric assessments are reliable, and clinical outcomes of telepsychiatric interventions are comparable to conventional treatment among diverse patient populations, ages and diagnostic groups, and on a wide range of measures. However, on many aspects of effectiveness, the evidence base is still relatively limited and often compromised by methodological problems. The lack of cost-effectiveness data in particular, is a major hindrance, raising doubts about the continued viability of telepsychiatric services. Added to this are the vagaries of technology, negative views among clinicians, poor uptake by providers, and several legal, ethical and administrative barriers. These hamper the widespread implementation of telepsychiatry and its integration with routine care. Though further advances in technology and research are expected to solve many of these problems, the way forward would be to promote telepsychiatry as an adjunct to conventional care, and to develop hybrid models, which incorporate both traditional and telepsychiatric forms of mental health-care.
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Nguyen DP, Klein B, Meyer D, Austin DW, Abbott JAM. The Diagnostic Validity and Reliability of an Internet-Based Clinical Assessment Program for Mental Disorders. J Med Internet Res 2015; 17:e218. [PMID: 26392066 PMCID: PMC4642400 DOI: 10.2196/jmir.4195] [Citation(s) in RCA: 22] [Impact Index Per Article: 2.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/02/2015] [Revised: 05/21/2015] [Accepted: 07/08/2015] [Indexed: 01/18/2023] Open
Abstract
Background Internet-based assessment has the potential to assist with the diagnosis of mental health disorders and overcome the barriers associated with traditional services (eg, cost, stigma, distance). Further to existing online screening programs available, there is an opportunity to deliver more comprehensive and accurate diagnostic tools to supplement the assessment and treatment of mental health disorders. Objective The aim was to evaluate the diagnostic criterion validity and test-retest reliability of the electronic Psychological Assessment System (e-PASS), an online, self-report, multidisorder, clinical assessment and referral system. Methods Participants were 616 adults residing in Australia, recruited online, and representing prospective e-PASS users. Following e-PASS completion, 158 participants underwent a telephone-administered structured clinical interview and 39 participants repeated the e-PASS within 25 days of initial completion. Results With structured clinical interview results serving as the gold standard, diagnostic agreement with the e-PASS varied considerably from fair (eg, generalized anxiety disorder: κ=.37) to strong (eg, panic disorder: κ=.62). Although the e-PASS’ sensitivity also varied (0.43-0.86) the specificity was generally high (0.68-1.00). The e-PASS sensitivity generally improved when reducing the e-PASS threshold to a subclinical result. Test-retest reliability ranged from moderate (eg, specific phobia: κ=.54) to substantial (eg, bulimia nervosa: κ=.87). Conclusions The e-PASS produces reliable diagnostic results and performs generally well in excluding mental disorders, although at the expense of sensitivity. For screening purposes, the e-PASS subclinical result generally appears better than a clinical result as a diagnostic indicator. Further development and evaluation is needed to support the use of online diagnostic assessment programs for mental disorders. Trial Registration Australian and New Zealand Clinical Trials Registry ACTRN121611000704998; http://www.anzctr.org.au/trial_view.aspx?ID=336143 (Archived by WebCite at http://www.webcitation.org/618r3wvOG).
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Affiliation(s)
- David Phong Nguyen
- National eTherapy Centre, Swinburne University of Technology, Hawthorn, VIC, Australia.
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Rutherford C, Costa D, Mercieca-Bebber R, Rice H, Gabb L, King M. Mode of administration does not cause bias in patient-reported outcome results: a meta-analysis. Qual Life Res 2015; 25:559-74. [PMID: 26334842 DOI: 10.1007/s11136-015-1110-8] [Citation(s) in RCA: 84] [Impact Index Per Article: 8.4] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 08/18/2015] [Indexed: 01/18/2023]
Abstract
PURPOSE Technological advances in recent decades have led to the availability of new modes to administer patient-reported outcomes (PROs). To aid selecting optimal modes of administration (MOA), we undertook a systematic review to determine whether differences in bias (both size and direction) exist among modes. METHODS We searched five electronic databases from 2004 (date of last comprehensive review on this topic) to April 2014, cross-referenced and searched reference lists. Studies that compared two or more MOA for a health-related PRO measure in adult samples were included. Two reviewers independently applied inclusion and quality criteria and extracted findings. Meta-analyses and meta-regressions were conducted using random-effects models. RESULTS Of 5100 papers screened, 222 were considered potentially relevant and 56 met eligibility criteria. No evidence of bias was found for: (1) paper versus electronic self-complete; and (2) self-complete versus assisted MOA. Heterogeneity for paper versus electronic comparison was explained by type of construct (i.e. physical vs. psychological). Heterogeneity for self-completion versus assisted modes was in part explained by setting (clinic vs. home); the largest bias was introduced when assisted completion occurred in the clinic and follow-up was by self-completion (either electronic or paper) in the home. CONCLUSIONS Self-complete paper and electronic MOA can be used interchangeably for research in clinic and home settings. Self-completion and assisted completion produce equivalent scores overall, although heterogeneity may be induced by setting. These results support the use of mixed MOAs within a research study, which may be a useful strategy for reducing missing PRO data.
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Affiliation(s)
- Claudia Rutherford
- Quality of Life Office, Psycho-oncology Co-operative Research Group, School of Psychology, University of Sydney, Level 6 North, Chris O'Brien Lifehouse (C39Z), Sydney, NSW, Australia.
| | - Daniel Costa
- Quality of Life Office, Psycho-oncology Co-operative Research Group, School of Psychology, University of Sydney, Level 6 North, Chris O'Brien Lifehouse (C39Z), Sydney, NSW, Australia
| | - Rebecca Mercieca-Bebber
- Quality of Life Office, Psycho-oncology Co-operative Research Group, School of Psychology, University of Sydney, Level 6 North, Chris O'Brien Lifehouse (C39Z), Sydney, NSW, Australia
- Sydney Medical School, University of Sydney, Sydney, NSW, Australia
| | - Holly Rice
- Centre for Medical Psychology and Evidence-Based Decision-Making, School of Psychology, University of Sydney, Sydney, NSW, Australia
| | | | - Madeleine King
- Quality of Life Office, Psycho-oncology Co-operative Research Group, School of Psychology, University of Sydney, Level 6 North, Chris O'Brien Lifehouse (C39Z), Sydney, NSW, Australia
- Sydney Medical School, University of Sydney, Sydney, NSW, Australia
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Azar KMJ, Aurora M, Wang EJ, Muzaffar A, Pressman A, Palaniappan LP. Virtual small groups for weight management: an innovative delivery mechanism for evidence-based lifestyle interventions among obese men. Transl Behav Med 2015; 5:37-44. [PMID: 25729451 DOI: 10.1007/s13142-014-0296-6] [Citation(s) in RCA: 45] [Impact Index Per Article: 4.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/18/2023] Open
Abstract
While group interventions for weight management have been shown to be efficacious, adherence is often low, especially among men. This pilot study seeks to test whether group interventions using web-based group video conferencing (VC) technology is effective for weight loss. We adapted a 12-week curriculum based on the Diabetes Prevention Program, and delivered this intervention to a small group of men (BMI ≥30 kg/m(2)), using web-based group VC. Participants were randomized to intervention (n = 32) or delayed-intervention control group (n = 32). The intervention group lost 3.5 % (95 % CI 2.1 %, 4.9 %) of their initial body weight. Difference in mean weight loss was 3.2 kg (p = 0.0002) and mean BMI decrease was 1.0 kg/m(2) (p = 0.0010) between the two groups. Virtual small groups may be an effective means of allowing face-to-face group interaction, while overcoming some barriers to access.
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Affiliation(s)
- Kristen M J Azar
- Palo Alto Medical Foundation Research Institute, Palo Alto, CA USA
| | - Magi Aurora
- Palo Alto Medical Foundation Research Institute, Palo Alto, CA USA
| | - Elsie J Wang
- Palo Alto Medical Foundation Research Institute, Palo Alto, CA USA
| | - Amy Muzaffar
- Palo Alto Medical Foundation Research Institute, Palo Alto, CA USA
| | - Alice Pressman
- Palo Alto Medical Foundation Research Institute, Palo Alto, CA USA
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Alvarado R, Rojas G, Minoletti A, Alvarado F, Domínguez C. Depression Program in Primary Health Care. INTERNATIONAL JOURNAL OF MENTAL HEALTH 2014. [DOI: 10.2753/imh0020-7411410103] [Citation(s) in RCA: 17] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/05/2022]
Affiliation(s)
- Rubén Alvarado
- a School of Public Health, Faculty of Medicine, University of Chile, Santiago, Chile
| | - Graciela Rojas
- b Department of Psychiatry and Mental Health, Faculty of Medicine, University of Chile, Independencia 1027, Santiago, Chile
| | - Alberto Minoletti
- a School of Public Health, Faculty of Medicine, University of Chile, Santiago, Chile
| | - Francisca Alvarado
- c School of Medicine, Faculty of Medicine, University of Chile, Santiago, Chile
| | - Carlos Domínguez
- c School of Medicine, Faculty of Medicine, University of Chile, Santiago, Chile
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Hudson P, Trauer T, Kelly B, O'Connor M, Thomas K, Zordan R, Summers M. Reducing the psychological distress of family caregivers of home based palliative care patients: longer term effects from a randomised controlled trial. Psychooncology 2014; 24:19-24. [PMID: 25044819 PMCID: PMC4309500 DOI: 10.1002/pon.3610] [Citation(s) in RCA: 67] [Impact Index Per Article: 6.1] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/10/2013] [Revised: 05/05/2014] [Accepted: 06/03/2014] [Indexed: 01/18/2023]
Abstract
Background Palliative care incorporates comprehensive support of family caregivers because many of them experience burden and distress. However, evidence-based support initiatives are few. Purpose We evaluated a one-to-one psychoeducational intervention aimed at mitigating the distress of caregivers of patients with advanced cancer receiving home-based palliative care. We hypothesised that caregivers would report decreased distress as assessed by the General Health Questionnaire (GHQ). Method A randomised controlled trial comparing two versions of the delivery of the intervention (one face-to-face home visit plus telephone calls versus two visits) plus standard care to a control group (standard care only) across four sites in Australia. Results Recruitment to the one visit condition was 57, the two visit condition 93, and the control 148. We previously reported non-significant changes in distress between times 1 (baseline) and 2 (1-week post-intervention) but significant gains in competence and preparedness. We report here changes in distress between times 1 and 3 (8-week post-death). There was significantly less worsening in distress between times 1 and 3 in the one visit intervention group than in the control group; however, no significant difference was found between the two visit intervention and the control group. Conclusions These results are consistent with the aim of the intervention, and they support existing evidence demonstrating that relatively short psychoeducational interventions can help family caregivers who are supporting a dying relative. The sustained benefit during the bereavement period may also have positive resource implications, which should be the subject of future inquiry. © 2014 The Authors. Psycho-Oncology published by John Wiley & Sons Ltd.
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Affiliation(s)
- Peter Hudson
- Centre for Palliative Care, St. Vincent's Hospital, Melbourne, Australia; Queen's University, Belfast, Northern Ireland, UK; University of Melbourne, Melbourne, Victoria, Australia
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Duncan AB, Velasquez SE, Nelson EL. Using videoconferencing to provide psychological services to rural children and adolescents: a review and case example. JOURNAL OF CLINICAL CHILD AND ADOLESCENT PSYCHOLOGY 2013; 43:115-27. [PMID: 24079653 DOI: 10.1080/15374416.2013.836452] [Citation(s) in RCA: 30] [Impact Index Per Article: 2.5] [Reference Citation Analysis] [Abstract] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 01/18/2023]
Abstract
Children and adolescents living in rural areas have difficulty accessing psychological services due to a lack of psychologists and other behavioral health professionals, especially those with expertise in treating youth. Telepsychology helps bridge this access gap. This article extends evidence supporting videoconferencing for psychological assessment and treatment in adults to support telepsychological treatment for youth. In addition, the basic components needed to begin and sustain a telepsychological practice are explored. Finally, a case example of an adolescent presenting with depression and disordered eating illustrates the practice of, and ethical standards needed for, telepsychology. Future technologies and applications around telepsychology are also discussed.
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Affiliation(s)
- Angela Banitt Duncan
- a KU Center for Telemedicine and Telehealth, University of Kansas Medical Center
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Bondolfi G, Jermann F, Rouget BW, Gex-Fabry M, McQuillan A, Dupont-Willemin A, Aubry JM, Nguyen C. Self- and clinician-rated Montgomery-Asberg Depression Rating Scale: evaluation in clinical practice. J Affect Disord 2010; 121:268-72. [PMID: 19660815 DOI: 10.1016/j.jad.2009.06.037] [Citation(s) in RCA: 51] [Impact Index Per Article: 3.4] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/23/2009] [Revised: 06/30/2009] [Accepted: 06/30/2009] [Indexed: 11/26/2022]
Abstract
BACKGROUND Time- and cost-effective self-rating scales of depressive symptoms are particularly valuable for frequent use in large-scale effectiveness trials. The aim of the present study was to examine the psychometric properties of the French version of the self-rated Montgomery-Asberg Depression Rating Scale (MADRS-S) and determine whether it might complement the MADRS in monitoring depression severity and change over time in routine clinical practice. METHODS Sixty-three adult outpatients with a current depressive episode completed the MADRS-S and were interviewed with the MADRS on two occasions, within a 1-month interval. RESULTS All patients readily accepted the MADRS-S. It showed good to excellent internal consistency (Cronbach's alpha 0.85 at Time 1; 0.94 at Time 2). Its factor structure revealed that a single component explained a large proportion of variability (47.0% at Time 1; 68.8% at Time 2). Concurrent validity of the self- and clinician-rated versions was good (Pearson's correlation coefficients for total scores 0.81 at Time 1; 0.91 at Time 2). The MADRS-S was sensitive to change over the 4-week observation period (correlation of 0.71 between change scores on self- and clinician-rated instruments). LIMITATIONS Generalizability is restricted to outpatients with moderate to severe depression, and the MADRS-S ability to measure treatment effects needs to be examined. CONCLUSIONS The present study indicates that the MADRS-S displays favourable psychometric properties and suggests that it might be a valid complement to the MADRS, both in research settings and clinical practice.
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Affiliation(s)
- G Bondolfi
- Geneva University Hospitals, Department of Psychiatry, Division of Adult Psychiatry, Geneva, Switzerland.
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