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Tutino R, Schofield E, Saracino RM, Walsh L, Straus E, Nelson CJ. A survey of statistical methods utilized for analysis of randomized controlled trials of behavioral interventions. Palliat Support Care 2024; 22:221-225. [PMID: 37278213 PMCID: PMC10698204 DOI: 10.1017/s1478951523000512] [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] [Indexed: 06/07/2023]
Abstract
OBJECTIVES Given the many statistical analysis options used for randomized controlled trials (RCTs) of behavioral interventions and the lack of clear guidance for analysis selection, the present study aimed to characterize the predominate statistical analyses utilized in RCTs in palliative care and behavioral research and to highlight the relative strengths and weaknesses of each of these methods as guidance for future researchers and reform. METHODS All RCTs published between 2015 and 2021 were systematically extracted from 4 behavioral medicine journals and analyzed based on prespecified inclusion criteria. Two independent raters classified each of the manuscripts into 1 of 5 RCT analysis strategies. RESULTS There was wide variation in the methods used. The 2 most prevalent analyses for RCTs were longitudinal modeling and analysis of covariance. Application of method varied significantly by sample size. SIGNIFICANCE OF RESULTS Each statistical analysis presents its own unique strengths and weaknesses. The information resulting from this research may prove helpful for researchers in palliative care and behavioral medicine in navigating the variety of statistical methods available. Future discussion around best practices in RCT analyses is warranted to compare the relative impact of interventions in a more standardized way.
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Affiliation(s)
- Rebecca Tutino
- Department of Psychiatry and Behavioral Sciences, Memorial Sloan Kettering Cancer Center, New York, NY, USA
- Department of Psychology, Fordham University, Bronx, NY, USA
| | - Elizabeth Schofield
- Department of Psychiatry and Behavioral Sciences, Memorial Sloan Kettering Cancer Center, New York, NY, USA
| | - Rebecca M. Saracino
- Department of Psychiatry and Behavioral Sciences, Memorial Sloan Kettering Cancer Center, New York, NY, USA
| | - Leah Walsh
- Department of Psychiatry and Behavioral Sciences, Memorial Sloan Kettering Cancer Center, New York, NY, USA
- Department of Psychology, Fordham University, Bronx, NY, USA
| | - Emma Straus
- Department of Psychiatry and Behavioral Sciences, Memorial Sloan Kettering Cancer Center, New York, NY, USA
| | - Christian J. Nelson
- Department of Psychiatry and Behavioral Sciences, Memorial Sloan Kettering Cancer Center, New York, NY, USA
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Andrade C. Understanding Statistical Noise in Research: 2. Noise in Clinical Trials and Observational Studies. Indian J Psychol Med 2023; 45:198-200. [PMID: 36925488 PMCID: PMC10011845 DOI: 10.1177/02537176221149162] [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] [Indexed: 02/04/2023] Open
Abstract
The previous article in this series explained basic concepts related to statistical signals and statistical noise in research. This article explains statistical noise in the context of randomized controlled trials (RCTs) and observational studies and offers suggestions on how noise in such studies may be reduced so as to better detect and understand the signal. Postrandomization bias related to RCTs and confounding in observational studies are discussed. Examples are provided to facilitate understanding.
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Affiliation(s)
- Chittaranjan Andrade
- Dept. of Clinical Psychopharmacology and Neurotoxicology, National Institute of Mental Health and Neurosciences, Bangalore, Karnataka, India
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Arora NK, Roehrken G, Crumbach S, Phatak A, Labott BK, Nicklas A, Wicker P, Donath L. Good Scientific Practice and Ethics in Sports and Exercise Science: A Brief and Comprehensive Hands-on Appraisal for Sports Research. Sports (Basel) 2023; 11:sports11020047. [PMID: 36828332 PMCID: PMC9964730 DOI: 10.3390/sports11020047] [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: 01/21/2023] [Revised: 02/12/2023] [Accepted: 02/14/2023] [Indexed: 02/18/2023] Open
Abstract
Sports and exercise training research is constantly evolving to maintain, improve, or regain psychophysical, social, and emotional performance. Exercise training research requires a balance between the benefits and the potential risks. There is an inherent risk of scientific misconduct and adverse events in most sports; however, there is a need to minimize it. We aim to provide a comprehensive overview of the clinical and ethical challenges in sports and exercise research. We also enlist solutions to improve method design in clinical trials and provide checklists to minimize the chances of scientific misconduct. At the outset, historical milestones of exercise science literature are summarized. It is followed by details about the currently available regulations that help to reduce the risk of violating good scientific practices. We also outline the unique characteristics of sports-related research with a narrative of the major differences between sports and drug-based trials. An emphasis is then placed on the importance of well-designed studies to improve the interpretability of results and generalizability of the findings. This review finally suggests that sports researchers should comply with the available guidelines to improve the planning and conduct of future research thereby reducing the risk of harm to research participants. The authors suggest creating an oath to prevent malpractice, thereby improving the knowledge standards in sports research. This will also aid in deriving more meaningful implications for future research based on high-quality, ethically sound evidence.
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Affiliation(s)
- Nitin Kumar Arora
- Department of Intervention Research in Exercise Training, German Sport University Cologne, 50933 Cologne, Germany
- Department of Physiotherapy, University of Applied Sciences, 44801 Bochum, Germany
| | - Golo Roehrken
- Department of Intervention Research in Exercise Training, German Sport University Cologne, 50933 Cologne, Germany
| | - Sarah Crumbach
- Institute of Sport Economics and Sport Management, German Sport University Cologne, 50933 Cologne, Germany
| | - Ashwin Phatak
- Institute of Exercise Training and Sport Informatics, German Sport University Cologne, 50933 Cologne, Germany
| | - Berit K. Labott
- Department of Intervention Research in Exercise Training, German Sport University Cologne, 50933 Cologne, Germany
- Institute of Sport Sciences, Otto-von-Guericke University, 39106 Magdeburg, Germany
| | - André Nicklas
- Institute of Exercise Training and Sport Informatics, German Sport University Cologne, 50933 Cologne, Germany
| | - Pamela Wicker
- Department of Sports Science, Bielefeld University, 33615 Bielefeld, Germany
- Correspondence:
| | - Lars Donath
- Department of Intervention Research in Exercise Training, German Sport University Cologne, 50933 Cologne, Germany
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Abstract
In the phase between ovulation and potential implantation of the egg, and especially during pregnancy, females downregulate their immune system to prevent it from attacking the (future) embryo, which is after all a half-foreign organism. Yet this adaptive mechanism, that is set off by rising progesterone, makes females more vulnerable to pathogens at those critical times. It has been proposed that, to compensate this depression of physiological immunity, progesterone reinforces behavioral immunity-by increasing proneness to disgust and hence active avoidance of infection-but evidence is inconclusive and indirect. Manipulating progesterone directly, a recent, crucial study on female mice's disgust for infected males came up empty handed. Here, reanalyzing these data in a more statistically sensitive manner, we show that progesterone not only raises disgust but does so in a way that is both significant and substantial.
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Affiliation(s)
- Paola Bressan
- Dipartimento di Psicologia Generale, University of Padova, Via Venezia 8, 35131 Padova, Italy.
| | - Peter Kramer
- Dipartimento di Psicologia Generale, University of Padova, Via Venezia 8, 35131 Padova, Italy.
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Azukizawa K, Hirose K, Morigami Y, Higashi N, Uchida H, Hirao K. Positive-word stimuli via a smartphone application have no immediate-term effects on multi-directional reach ability in standing position: a randomized controlled trial. Ann Med 2021; 53:1402-1409. [PMID: 34414832 PMCID: PMC8381964 DOI: 10.1080/07853890.2021.1968483] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/01/2021] [Accepted: 08/10/2021] [Indexed: 11/04/2022] Open
Abstract
OBJECTIVES The purpose of the study was to examine the immediate-term effect of positive-word stimuli via a smartphone application on the multi-directional reach ability in standing position in young adults. METHODS This study was an immediate-term, assessor-blinded, two-arm, parallel-group, randomized controlled trial among young adults recruited from one university in Japan. Participants were randomly assigned to the experimental group or control group using a computer-based random number-generating programme. Participants of the experimental group used an application on iPhone and watched 3-min videos displaying positive-word stimuli. This application repeatedly displayed positive-word stimuli every 5 s. The participants of the control group used an application on iPhone and watched the same videos as in the experimental group. However, a positive-word stimulus did not appear in the videos. The primary outcome was the multi-directional reach test (MDRT) from baseline to immediately after the intervention protocol. RESULTS Among the 62 randomized participants (experimental group, n = 31; control group, n = 31), 62 (100%) completed the MDRT immediately after the intervention protocol. There were no differences in mean group change values in MDRT between the experimental and control groups. CONCLUSIONS Among young adults, positive-word stimuli via a smartphone application did not significantly improve multi-directional reach ability in standing position. These findings do not support the superiority of this intervention among young adults. Trial Registration: Clinicaltrials.gov, NCT03546218. Registered 6 June 2018, https://clinicaltrials.gov/ct2/show/NCT03546218KEY MESSAGESIn our study, among young adults, positive-word stimuli via an SPSRS application did not significantly improve the multi-directional reach ability in the standing position.These findings do not support the superiority of this intervention among young adults.
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Affiliation(s)
- Kenta Azukizawa
- Department of Rehabilitation, Oda Municipal Hospital, Oda, Japan
| | - Kodai Hirose
- Department of Rehabilitation, Ochiai Hospital, Maniwa, Japan
| | - Yuta Morigami
- Department of Occupational Therapy, Kibi International University, Takahashi, Japan
| | - Naoki Higashi
- Department of Occupational Therapy, Kibi International University, Takahashi, Japan
| | - Hiroyuki Uchida
- Department of Rehabilitation, Kurashiki Heisei Hospital, Kurashiki, Japan
| | - Kazuki Hirao
- Graduate School of Health Sciences, Gunma University, Maebashi, Japan
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Giesbrecht E, Faieta J, Best K, Routhier F, Miller WC, Laberge M. Impact of the TEAM Wheels eHealth manual wheelchair training program: Study protocol for a randomized controlled trial. PLoS One 2021; 16:e0258509. [PMID: 34644350 PMCID: PMC8513836 DOI: 10.1371/journal.pone.0258509] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/24/2021] [Accepted: 09/20/2021] [Indexed: 12/05/2022] Open
Abstract
Background Variable, and typically inadequate, delivery of skills training following manual wheelchair (MWC) provision has a detrimental impact on user mobility and participation. Traditional in-person delivery of training by rehabilitation therapists has diminished due to cost, travel time, and most recently social distancing restrictions due to COVID-19. Effective alternative training approaches include eHealth home training applications and interactive peer-led training using experienced and proficient MWC users. An innovative TEAM Wheels program integrates app-based self-training and teleconference peer-led training using a computer tablet platform. Objective This protocol outlines implementation and evaluation of the TEAM Wheels training program in a randomized control trial using a wait-list control group. Setting The study will be implemented in a community setting in three Canadian cities. Participants Individuals ≥ 18 years of age within one year of transitioning to use of a MWC. Intervention Using a computer tablet, participants engage in three peer-led teleconference training sessions and 75–150 minutes of weekly practice using a video-based training application over 4 weeks. Peer trainers individualize the participants’ training plans and monitor their tablet-based training activity online. Control group participants also receive the intervention following a 1-month wait-list period and data collection. Measurements Outcomes assessing participation; skill capacity and performance; self-efficacy; mobility; and quality of life will be measured at baseline and post-treatment, and at 6-month follow-up for the treatment group. Impact statement We anticipate that TEAM Wheels will be successfully carried out at all sites and participants will demonstrate statistically significant improvement in the outcome measures compared with the control group.
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Affiliation(s)
- Ed Giesbrecht
- Department of Occupational Therapy, University of Manitoba, Winnipeg, Manitoba, Canada
- * E-mail:
| | - Julie Faieta
- Department of Health and Rehabilitation Sciences, University of Pittsburgh, Pittsburgh, Pennsylvania, United States of America
| | - Krista Best
- Department of Rehabilitation, Université Laval, Quebec City, Quebec, Canada
- Centre interdisciplinaire de recherche en réadaptation et en intégration sociale (CIRRIS), Centre intégré universitaire de santé et de services sociaux de la Capitale-Nationale (CIUSSS-CN), Quebec City, Quebec, Canada
| | - François Routhier
- Department of Rehabilitation, Université Laval, Quebec City, Quebec, Canada
- Centre interdisciplinaire de recherche en réadaptation et en intégration sociale (CIRRIS), Centre intégré universitaire de santé et de services sociaux de la Capitale-Nationale (CIUSSS-CN), Quebec City, Quebec, Canada
| | - William C. Miller
- Department of Occupational Science & Occupational Therapy, University of British Columbia, Vancouver, British Columbia, Canada
| | - Maude Laberge
- Département d’opérations et systèmes de décision, Université Laval, Quebec City, Quebec, Canada
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Chang WL, Azlan A, Noor SM, Ismail IZ, Loh SP. Short-Term Intake of Yellowstripe Scad versus Salmon Did Not Induce Similar Effects on Lipid Profile and Inflammatory Markers among Healthy Overweight Adults despite Their Comparable EPA+DHA Content. Nutrients 2021; 13:3524. [PMID: 34684525 PMCID: PMC8539692 DOI: 10.3390/nu13103524] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/08/2021] [Revised: 10/01/2021] [Accepted: 10/04/2021] [Indexed: 11/25/2022] Open
Abstract
Yellowstripe scad (YSS) have comparable eicosapentaenoic acid and docosahexaenoic acid (EPA+DHA) content to salmon. We aimed to compare the effects of YSS and salmon on lipid profile and inflammatory markers. A randomized crossover trial with two diet periods was conducted among healthy overweight (with BMI 23.0-27.4 kg/m2) Malaysian adults aged 21-55 years. Steamed whole YSS fish (≈385 g whole fish/day) or salmon fillets (≈246 g fillet/day) were given for eight weeks (3 days per week), retaining approximately 1000 mg EPA+DHA per day. Diets were switched after an 8-week washout period. Fasting blood samples were collected before and after each diet period. A total of 49 subjects participated in the intervention (35% male and 65% female; mean age 29 (7) years). YSS did not induce any significant changes in outcome measures. However, the consumption of salmon as compared with YSS was associated with reduction in triglycerides (between-group difference: -0.09 mmol/1, p = 0.01), VLDL-cholesterol (between-group difference: -0.04 mmol/1, p = 0.01), atherogenic index of plasma (between-group difference: -0.05 mmol/1, p = 0.006), and IL-6 (between-group difference: -0.01 pg/mL, p = 0.03). Despite their comparable EPA+DHA content, short-term consumption of salmon but not YSS induced significant changes in lipid profile and inflammatory markers. Larger clinical trials are needed to confirm the findings.
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Affiliation(s)
- Wei Lin Chang
- Department of Nutrition, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Serdang 43400, Selangor, Malaysia; (W.L.C.); (A.A.)
| | - Azrina Azlan
- Department of Nutrition, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Serdang 43400, Selangor, Malaysia; (W.L.C.); (A.A.)
| | - Sabariah Md Noor
- Department of Pathology, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Serdang 43400, Selangor, Malaysia;
| | - Irmi Zarina Ismail
- Department of Family Medicine, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Serdang 43400, Selangor, Malaysia;
| | - Su Peng Loh
- Department of Nutrition, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Serdang 43400, Selangor, Malaysia; (W.L.C.); (A.A.)
- Department of Nutrition, Faculty of Public Health, Universitas Airlangga, Jl. Mulyorejo Kampus C, Surabaya 60115, Indonesia
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PRESENT 2020: Text Expanding on the Checklist for Proper Reporting of Evidence in Sport and Exercise Nutrition Trials. Int J Sport Nutr Exerc Metab 2021; 30:2-13. [PMID: 31945740 DOI: 10.1123/ijsnem.2019-0326] [Citation(s) in RCA: 36] [Impact Index Per Article: 9.0] [Reference Citation Analysis] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/07/2019] [Accepted: 11/07/2019] [Indexed: 11/18/2022]
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Wan F. Statistical analysis of two arm randomized pre-post designs with one post-treatment measurement. BMC Med Res Methodol 2021; 21:150. [PMID: 34303343 PMCID: PMC8305561 DOI: 10.1186/s12874-021-01323-9] [Citation(s) in RCA: 28] [Impact Index Per Article: 7.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/10/2021] [Accepted: 05/19/2021] [Indexed: 11/15/2022] Open
Abstract
Background Randomized pre-post designs, with outcomes measured at baseline and after treatment, have been commonly used to compare the clinical effectiveness of two competing treatments. There are vast, but often conflicting, amount of information in current literature about the best analytic methods for pre-post designs. It is challenging for applied researchers to make an informed choice. Methods We discuss six methods commonly used in literature: one way analysis of variance (“ANOVA”), analysis of covariance main effect and interaction models on the post-treatment score (“ANCOVAI” and “ANCOVAII”), ANOVA on the change score between the baseline and post-treatment scores (“ANOVA-Change”), repeated measures (“RM”) and constrained repeated measures (“cRM”) models on the baseline and post-treatment scores as joint outcomes. We review a number of study endpoints in randomized pre-post designs and identify the mean difference in the post-treatment score as the common treatment effect that all six methods target. We delineate the underlying differences and connections between these competing methods in homogeneous and heterogeneous study populations. Results ANCOVA and cRM outperform other alternative methods because their treatment effect estimators have the smallest variances. cRM has comparable performance to ANCOVAI in the homogeneous scenario and to ANCOVAII in the heterogeneous scenario. In spite of that, ANCOVA has several advantages over cRM: i) the baseline score is adjusted as covariate because it is not an outcome by definition; ii) it is very convenient to incorporate other baseline variables and easy to handle complex heteroscedasticity patterns in a linear regression framework. Conclusions ANCOVA is a simple and the most efficient approach for analyzing pre-post randomized designs. Supplementary Information The online version contains supplementary material available at 10.1186/s12874-021-01323-9.
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Affiliation(s)
- Fei Wan
- Department of Surgery, Division of Public Health Sciences, Washington University School of Medicine, Campus Box 8100, 660 S. Euclid Ave, St. Louis, MO, USA.
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Burn NL, Weston M, Atkinson G, Graham M, Weston KL. Brief Exercise at Work (BE@Work): A Mixed-Methods Pilot Trial of a Workplace High-Intensity Interval Training Intervention. Front Sports Act Living 2021; 3:699608. [PMID: 34278300 PMCID: PMC8282817 DOI: 10.3389/fspor.2021.699608] [Citation(s) in RCA: 8] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/23/2021] [Accepted: 05/31/2021] [Indexed: 11/13/2022] Open
Abstract
Introduction: The efficacy of high-intensity interval training (HIIT) for improving markers of physical fitness and cardiometabolic health is promising. The workplace is one non-laboratory setting where the effectiveness of HIIT could be explored. The aim of this study was to undertake a mixed-methods exploratory pilot trial of a workplace HIIT intervention named Brief Exercise at Work (BE@Work). Methods: Fifty-four healthy employees (mean ± standard deviation [SD] age 46 ± 10 years) from two workplaces in Northeast England were allocated to 8 weeks of thrice-weekly workplace HIIT based on boxing, stair climbing and stepping, comprising 4-7 60 s high-intensity intervals interspersed with 75 s rest (n = 30), or a no-intervention control (n = 24). The primary outcome was the change SD of predicted maximal oxygen consumption (VO2max). Markers of physical fitness, cardiometabolic health and mental well-being were also measured at baseline and follow-up. Participant perceptions of the intervention were explored in post-intervention focus groups (n = 9). Results: Mean (±SD) session attendance was 82% (±15%). Mean peak heart rate across the intervention was 87% of age-predicted maximal heart rate with a within- and between-subject SD of 5.5% and 3.7%, respectively. The SD of changes in predicted VO2max was 6.6 mL·kg-1·min-1 across both groups, which can be used to inform sample size estimations for a future full trial. The control-adjusted mean increase (95% confidence interval) in predicted VO2max was 3.9 (-0.2 to 8.1) mL·kg-1·min-1, corresponding to a Cohen's D of 0.47. We also observed preliminary evidence of small to moderate effects in favour of the intervention group for non-dominant leg extensor muscle power, markers of health-related quality of life, well-being and perceived stress and small to moderate effects in favour of the controls in perceived pain, physical activity and high-density lipoprotein cholesterol. During HIIT, focus group participants reported physiological responses they perceived as unpleasant or tiring (e.g., breathlessness, local muscular fatigue), but also that they felt alert and energised afterwards. Conclusion: The findings of this exploratory pilot trial support the implementation of a definitive randomised controlled trial to quantify the effectiveness of a workplace HIIT intervention.
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Affiliation(s)
- Naomi L Burn
- School of Health and Life Sciences, Teesside University, Middlesbrough, United Kingdom
| | - Matthew Weston
- School of Health and Life Sciences, Teesside University, Middlesbrough, United Kingdom
| | - Greg Atkinson
- School of Health and Life Sciences, Teesside University, Middlesbrough, United Kingdom
| | - Michael Graham
- School of Health and Life Sciences, Teesside University, Middlesbrough, United Kingdom
| | - Kathryn L Weston
- School of Applied Sciences, Edinburgh Napier University, Edinburgh, United Kingdom
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The influence of environmental and core temperature on cyclooxygenase and PGE2 in healthy humans. Sci Rep 2021; 11:6531. [PMID: 33753764 PMCID: PMC7985197 DOI: 10.1038/s41598-021-84563-5] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/18/2020] [Accepted: 01/21/2021] [Indexed: 11/08/2022] Open
Abstract
Whether cyclooxygenase (COX)/prostaglandin E2 (PGE2) thermoregulatory pathways, observed in rodents, present in humans? Participants (n = 9) were exposed to three environments; cold (20 °C), thermoneutral (30 °C) and hot (40 °C) for 120 min. Core (Tc)/skin temperature and thermal perception were recorded every 15 min, with COX/PGE2 concentrations determined at baseline, 60 and 120 min. Linear mixed models identified differences between and within subjects/conditions. Random coefficient models determined relationships between Tc and COX/PGE2. Tc [mean (range)] increased in hot [+ 0.8 (0.4-1.2) °C; p < 0.0001; effect size (ES): 2.9], decreased in cold [- 0.5 (- 0.8 to - 0.2) °C; p < 0.0001; ES 2.6] and was unchanged in thermoneutral [+ 0.1 (- 0.2 to 0.4) °C; p = 0.3502]. A relationship between COX2/PGE2 in cold (p = 0.0012) and cold/thermoneutral [collapsed, condition and time (p = 0.0243)] was seen, with higher PGE2 associated with higher Tc. A within condition relationship between Tc/PGE2 was observed in thermoneutral (p = 0.0202) and cold/thermoneutral [collapsed, condition and time (p = 0.0079)] but not cold (p = 0.0631). The data suggests a thermogenic response of the COX/PGE2 pathway insufficient to defend Tc in cold. Further human in vivo research which manipulates COX/PGE2 bioavailability and participant acclimation/acclimatization are warranted to elucidate the influence of COX/PGE2 on Tc.
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McPhee GM, Downey LA, Wesnes KA, Stough C. The Neurocognitive Effects of Bacopa monnieri and Cognitive Training on Markers of Brain Microstructure in Healthy Older Adults. Front Aging Neurosci 2021; 13:638109. [PMID: 33692683 PMCID: PMC7937913 DOI: 10.3389/fnagi.2021.638109] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/05/2020] [Accepted: 01/28/2021] [Indexed: 11/13/2022] Open
Abstract
Bacopa monnieri (BM) is a herbal supplement that increases signaling molecules implicated in synaptogenesis. Combined with cognitive stimulation, it may be a viable supplement to enhance long-term potentiation (LTP) and improve cognitive health in older adults. This randomized, double-blind, placebo-controlled trial asked 28 healthy adults aged over 55 years to complete cognitive training (CT) 3 hours weekly for 12 weeks. Fifteen consumed a standardized extract of BM and 13 consumed a placebo daily. Cognitive tasks, life-satisfaction, memory complaints and mood were assessed, and bloods analyzed for serum brain-derived neurotrophic factor (BDNF) before and after 12-weeks of the intervention. Diffusion tensor imaging (DTI) and neurite orientation dispersion and density imaging (NODDI) in gray (GM) and white matter (WM) were also analyzed. Results demonstrated slower reaction time in an image discrimination task in the BM group and faster reaction time in a spatial working memory task (SWM-O RT) in the placebo group. Mean accuracy was higher in the BM group for these tasks, suggesting a change in the speed accuracy trade-off. Exploratory neuroimaging analysis showed increased WM mean diffusivity (MD) and GM dispersion of neurites (orientation dispersion index, ODI) and decreased WM fractional anisotropy (FA) and GM neurite density (ND) in the BM group. No other outcomes reached statistical significance. An increase in ODI with a decrease in MD and ND in the BM group may indicate an increase in network complexity (through higher dendritic branching) accompanied by dendritic pruning to enhance network efficiency. These neuroimaging outcomes conflict with the behavioral results, which showed poorer reaction time in the BM group. Given the exploratory outcomes and inconsistent findings between the behavioral and neuroimaging data, a larger study is needed to confirm the synaptogenic mechanisms of BM.
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Affiliation(s)
- Grace M McPhee
- Centre for Human Psychopharmacology, Swinburne University of Technology, Melbourne, VIC, Australia
| | - Luke A Downey
- Centre for Human Psychopharmacology, Swinburne University of Technology, Melbourne, VIC, Australia.,Institute for Breathing and Sleep, Austin Health, Melbourne, VIC, Australia
| | - Keith A Wesnes
- Centre for Human Psychopharmacology, Swinburne University of Technology, Melbourne, VIC, Australia.,Wesnes Cognition Ltd., Streatley, United Kingdom.,University of Exeter Medical School, University of Exeter, Exeter, United Kingdom
| | - Con Stough
- Centre for Human Psychopharmacology, Swinburne University of Technology, Melbourne, VIC, Australia
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Prefrontal cortex hypoactivity distinguishes severe from mild-to-moderate social anxiety as revealed by a palm-sized near-infrared spectroscopy system. J Neural Transm (Vienna) 2020; 127:1305-1313. [PMID: 32638118 DOI: 10.1007/s00702-020-02228-5] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/31/2020] [Accepted: 07/02/2020] [Indexed: 12/17/2022]
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An Integrative Neuro-Psychotherapy Treatment to Foster the Adjustment in Acquired Brain Injury Patients-A Randomized Controlled Study. J Clin Med 2020; 9:jcm9061684. [PMID: 32498240 PMCID: PMC7355481 DOI: 10.3390/jcm9061684] [Citation(s) in RCA: 5] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/29/2020] [Revised: 05/25/2020] [Accepted: 05/28/2020] [Indexed: 12/18/2022] Open
Abstract
Adjustment disorders (AjD) with depressive symptoms following an acquired brain injury (ABI) is a common phenomenon. Although brain injuries are increasing more and more, research on psychological therapies is comparably scarce. The present study compared, by means of a randomized controlled trial (RCT), a newly developed integrative treatment (Standard PLUS) to a standard neuropsychological treatment (Standard). Primary outcomes were depressive symptoms assessed with the Beck Depression Inventory (BDI-II) at post-treatment and 6-month follow-up assessment. In total, 25 patients (80% after a stroke) were randomized to one of the two conditions. Intention-to-treat analyses showed that the two groups did not significantly differ either at post-treatment nor at follow-up assessment regarding depressive symptoms. Both treatments showed large within-group effect sizes on depressive symptoms. Regarding secondary outcomes, patients in the Standard PLUS condition reported more emotion regulation skills at post-assessment than in the control condition. However, this difference was not present anymore at follow-up assessment. Both treatments showed medium to large within-group effects sizes on most measures for patients suffering from an AjD after ABI. More research with larger samples is needed to investigate who profits from which intervention.
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Simper T, Agley J, DeSalle M, Todd J, Dutta T. Pilot study of the influence of self-coding on empathy within an introductory motivational interviewing training. BMC MEDICAL EDUCATION 2020; 20:43. [PMID: 32041588 PMCID: PMC7011448 DOI: 10.1186/s12909-020-1956-5] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Figures] [Subscribe] [Scholar Register] [Received: 07/09/2019] [Accepted: 01/30/2020] [Indexed: 06/10/2023]
Abstract
BACKGROUND Motivational interviewing (MI) is a framework for addressing behavior change that is often used by healthcare professionals. Expression of empathy during MI is associated with positive client outcomes, while absence of empathy may produce iatrogenic effects. Although training in MI is linked to increased therapeutic empathy in learners, no research has investigated individual training components' contribution to this increase. The objective of this study was to test whether a self-coding MI exercise using smartphones completed at hour 6 of an 8-h MI training was superior in engendering empathy to training as usual (watching an MI expert perform in a video clip for the same duration at the same point in the training). METHODS This was a pilot study at two sites using randomization and control groups with 1:1 allocation. Allocation was achieved via computerized assignment (site 1, United Kingdom) or facedown playing card distribution (site 2, United States). Participants were 58 students attending a university class at one of two universities, of which an 8-h segment was dedicated to a standardized MI training. Fifty-five students consented to participate and were randomized. The intervention was an MI self-coding exercise using smartphone recording and a standardized scoring sheet. Students were encouraged to reflect on areas of potential improvement based on their self-coding results. The main outcome measure was score on the Helpful Responses Questionnaire, a measure of therapeutic empathy, collected prior to and immediately following the 8-h training. Questionnaire coding was completed by 2 blinded external reviewers and assessed for interrater reliability, and students were assigned averaged empathy scores from 6 to 30. Analyses were conducted via repeated-measures ANOVA using the general linear model. RESULTS Fifty-five students were randomized, and 2 were subsequently excluded from analysis at site 2 due to incomplete questionnaires. The study itself was feasible, and overall therapeutic empathy increased significantly and substantially among students. However, the intervention was not superior to the control condition in this study. CONCLUSIONS Replacing a single passive learning exercise with an active learning exercise in an MI training did not result in a substantive boost to therapeutic empathy. However, consistently with prior research, this study identified significant overall increases in empathy following introductory MI training. A much larger study examining the impact of selected exercises and approaches would likely be useful and informative.
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Affiliation(s)
| | - Jon Agley
- Prevention Insights, Department of Applied Health Science, School of Public Health-Bloomington, Indiana University, 501 N. Morton St., Suite 110, Bloomington, IN, 47404, USA.
| | - Mallori DeSalle
- Prevention Insights, Department of Applied Health Science, School of Public Health-Bloomington, Indiana University, 501 N. Morton St., Suite 110, Bloomington, IN, 47404, USA
| | - Jennifer Todd
- Department of Social Work, College of Health and Human Services, Indiana State University, Terre Haute, IN, USA
| | - Tapati Dutta
- Health Sciences Department, Fort Lewis College, Durango, CO, USA
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16
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Atkinson G, Williamson P, Batterham AM. Issues in the determination of 'responders' and 'non-responders' in physiological research. Exp Physiol 2019; 104:1215-1225. [PMID: 31116468 DOI: 10.1113/ep087712] [Citation(s) in RCA: 77] [Impact Index Per Article: 12.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/19/2019] [Accepted: 05/21/2019] [Indexed: 01/06/2023]
Abstract
NEW FINDINGS What is the topic for this review? We discuss the dichotomization of continuous-level physiological measurements into 'responders' and 'non-responders' when interventions/treatments are examined in robust parallel-group studies. What advances does it highlight? Sample responder counts are biased by pre-to-post within-subject variability. Sample differences in counts may be explained wholly by differences in mean response, even without individual response heterogeneity and even if test-retest measurement error informs the choice of response threshold. A less biased and more informative approach uses the SD of individual responses to estimate the chance a new person from the population of interest will be a responder. ABSTRACT As a follow-up to our 2015 review, we cover more issues on the topic of 'response heterogeneity', which we define as clinically important individual differences in the physiological responses to the same treatment/intervention that cannot be attributed to random within-subject variability. We highlight various pitfalls with the common practice of counting the number of 'responders', 'non-responders' and 'adverse responders' in samples that have been given certain treatments or interventions for research purposes. We focus on the classical parallel-group randomized controlled trial and assume typical good practice in trial design. We show that sample responder counts are biased because individuals differ in terms of pre-to-post within-subject random variability in the study outcome(s) and not necessarily treatment response. Ironically, sample differences in responder counts may be explained wholly by sample differences in mean response, even if there is no response heterogeneity at all. Sample comparisons of responder counts also have relatively low statistical precision. These problems do not depend on how the response threshold has been selected, e.g. on the basis of a measurement error statistic, and are not rectified fully by the use of confidence intervals for individual responses in the sample. The dichotomization of individual responses in a research sample is fraught with pitfalls. Less biased approaches for estimating the proportion of responders in a population of interest are now available. Importantly, these approaches are based on the SD for true individual responses, directly incorporating information from the control group.
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Affiliation(s)
- Greg Atkinson
- School of Health and Social Care, Teesside University, Middlesbrough, UK
| | - Philip Williamson
- Faculty of Health Sciences, School of Life Sciences, University of Hull, Hull, UK
| | - Alan M Batterham
- School of Health and Social Care, Teesside University, Middlesbrough, UK
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Houghton DC, Uhde TW, Borckardt JJ, Cortese BM. Exploratory Investigation of a Brief Cognitive Behavioral Intervention and Transcranial Direct Current Stimulation on Odor Sensitivity. Psychosom Med 2019; 81:389-395. [PMID: 30762663 PMCID: PMC6961818 DOI: 10.1097/psy.0000000000000679] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/07/2023]
Abstract
OBJECTIVE Enhanced odor sensitivity is a phenomenon that potentially underlies conditions such as multiple chemical sensitivity (MCS). Currently, there are no treatments that have been shown to effectively decrease odor sensitivity. Given similarities of odor hypersensitivity/MCS to pain sensitization disorders such as fibromyalgia, there may be a potential for interventions that improve pain tolerance to modulate odor sensitivity. METHODS This exploratory study randomized 72 healthy community adult volunteers to receive one of six treatments in between two assessments of thermal pain tolerance and odor threshold. Participants were randomized to receive either cathodal, anodal, or sham transcranial direct current stimulation (tDCS) aimed at dorsolateral prefrontal cortex. In addition, participants were provided a brief cognitive behavioral intervention (CBI) for pain consisting of task framing, cognitive restructuring, and distraction technique training, or a control intervention consisting of information about pain. RESULTS Persons who received a brief CBI showed significantly increased odor thresholds (reduced sensitivity) during intervention (F (1,62) = 7.29, p = .009, ηp = .11), whereas the control intervention was not associated with altered odor thresholds. Moreover, in those who received brief CBI, more severe anxiety associated with larger reductions in odor sensitivity (ρ = .364, p = .035). There was no effect of tDCS (F (2,62) = .11, p = .90) nor interaction between tDCS and CBI (F (2,62) = .32, p = .73). CONCLUSIONS Given the connection between anxiety and MCS, results suggest that CBT techniques for somatic processes may show promise in treating conditions characterized by increased sensitivity to odors (e.g., MCS).
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Affiliation(s)
- David C. Houghton
- Department of Psychiatry & Behavioral Sciences, Medical University of South Carolina, Charleston, SC, USA
- Psychological and Brain Sciences Department, Texas A&M University, College Station, TX, USA
| | - Thomas W. Uhde
- Department of Psychiatry & Behavioral Sciences, Medical University of South Carolina, Charleston, SC, USA
| | - Jeffrey J. Borckardt
- Department of Psychiatry & Behavioral Sciences, Medical University of South Carolina, Charleston, SC, USA
| | - Bernadette M. Cortese
- Department of Psychiatry & Behavioral Sciences, Medical University of South Carolina, Charleston, SC, USA
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18
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Musekamp G, Gerlich C, Ehlebracht-Kï Nig I, Dorn M, Hï Fter A, Tomiak C, Schlittenhardt D, Faller H, Reusch A. Evaluation of a self-management patient education programme for fibromyalgia-results of a cluster-RCT in inpatient rehabilitation. HEALTH EDUCATION RESEARCH 2019; 34:209-222. [PMID: 30689860 DOI: 10.1093/her/cyy055] [Citation(s) in RCA: 12] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Received: 12/22/2017] [Accepted: 01/01/2019] [Indexed: 06/09/2023]
Abstract
The objective was to evaluate the effectiveness of a self-management patient education programme for fibromyalgia syndrome (FMS) as compared with usual care education in inpatient rehabilitation. In a multicentre cluster-randomized controlled trial, 583 inpatients in 3 rehabilitation centres received an advanced self-management patient education programme or usual care education. Patients completed questionnaires at admission, discharge and after 6 and 12 months. Primary outcomes were disease- and treatment-specific knowledge at discharge, and self-management-competencies after 6 months. Secondary outcomes included satisfaction, attitudes, coping competencies, psychological distress and health impairment. We found a medium-sized effect on disease- and treatment-specific knowledge at discharge (P < 0.05, Cohen's d = 0.45, 95% CI = 0.27-0.63), and small effects for subjective knowledge, pain-related control, self-monitoring and insight, communication about disease, action planning for physical activity and treatment satisfaction (all P < 0.05). Only the effect on knowledge persisted for 6 and 12 months. This advanced education programme seemed to be more effective in the short term than usual education. However, intermediate- and long-term effects did not emerge. While superior long-term effects on knowledge as well as short-term effects on self-management skills may suggest implementation, additional long-term effects on other patient-relevant outcomes would be desirable. Trial registration: German Clinical Trials Register, DRKS00008782, Registered 8 July 2015.
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Affiliation(s)
- G Musekamp
- Department of Medical Psychology and Psychotherapy, Medical Sociology and Rehabilitation Sciences, Julius-Maximilians-University of W�rzburg, W�rzburg, Germany
| | - C Gerlich
- Department of Medical Psychology and Psychotherapy, Medical Sociology and Rehabilitation Sciences, Julius-Maximilians-University of W�rzburg, W�rzburg, Germany
| | | | - M Dorn
- Rehabilitation Centre Bad Eilsen, Bad Eilsen, Germany
| | - A Hï Fter
- Rehabilitation Centre Bad Aibling, Clinic Wendelstein, Bad Aibling, Germany
| | - C Tomiak
- Rehabilitation Centre Bad Aibling, Clinic Wendelstein, Bad Aibling, Germany
| | - D Schlittenhardt
- Rehabilitation Clinic Bad S�ckingen GmbH, Bad S�ckingen, Germany
| | - H Faller
- Department of Medical Psychology and Psychotherapy, Medical Sociology and Rehabilitation Sciences, Julius-Maximilians-University of W�rzburg, W�rzburg, Germany
| | - A Reusch
- Department of Medical Psychology and Psychotherapy, Medical Sociology and Rehabilitation Sciences, Julius-Maximilians-University of W�rzburg, W�rzburg, Germany
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Qi F, Kong Z, Xiao T, Leong K, Zschorlich VR, Zou L. Effects of Combined Training on Physical Fitness and Anthropometric Measures among Boys Aged 8 to 12 Years in the Physical Education Setting. SUSTAINABILITY 2019; 11:1219. [DOI: 10.3390/su11051219] [Citation(s) in RCA: 7] [Impact Index Per Article: 1.2] [Reference Citation Analysis] [Abstract] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 06/06/2025]
Abstract
Some studies have shown that resistance training combined with plyometric training is more time-efficient and effective for fitness development. The degree and frequency of combined training might influence the benefit of training to maintain time. To better understand this phenomenon of the degree and frequency of combined training in pre- and early pubertal boys, we have provided a more specific recommendation for physical education teachers thus that they are able to prescribe an exercise plan for their students in the physical education setting. We aimed to investigate the effects of combined training followed by 12 weeks of a reduced/detraining period on physical fitness and anthropometric features in 8 to 12-year old boys. Forty-six healthy boys were randomly assigned to either an experimental group (EG, n = 31) or a control group (CG, n = 15). Besides regular physical education classes (PE), participants in the EG performed a combined training program (resistance and plyometric training) twice weekly for 12 weeks. In the CG, participants only underwent PE classes twice per week. Then, the trained boys were randomly assigned to either a reduced training group (RTG, n = 14) or a training cessation group (TCG, n = 17). The RTG continued a reduced combined training program once a week with PE for additional 12 weeks. In the TCG, participants only kept their PE classes twice a week for 12 weeks. We assessed physical fitness performances (biceps curl, leg power, and running speed) and anthropometric features at baseline, after 12 weeks of combined training, and after 12 weeks of reduced training/detraining. We observed a significantly greater decrease in biceps girth in the EG (p = 0.049, d = 0.636), as compared to the CG. With regard to the physical fitness measures after the 12-week combined training, the EG showed significantly greater increase on biceps curl (p = 0.005, d = 0.92) and standing long jump (p = 0.015, d = 0.8) in comparison with the CG, whereas a significantly greater improvement on 30 m sprint speed (p = 0.031, d = 0.707) was observed in the EG, as compared to the CG. With regard to detraining and reduced training, results indicated a significantly greater increase on this outcome in the RTG (p = 0.038, d = 0.938), as compared to the TCG. Resistance training combined with plyometric training can be a safe and effective way to enhance the selected aspects of physical fitness, as well as reduce muscular girth in boys aged between 8 and 12 years. The frequency of one session per week in the combined training seems to provide an additional benefit to prevent leg power of lower limb from rapid deterioration.
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Affiliation(s)
- Fengxue Qi
- Department of Movement Science, Institute of Sport Science, University of Rostock, 18057 Rostock, Germany
| | - Zhaowei Kong
- Faculty of Education, University of Macau, Taipa, Macau, China
| | - Tao Xiao
- College of Mathematics and Statistics, Shenzhen University, Shenzhen 518060, China
| | - Kinwa Leong
- Faculty of Education, University of Macau, Taipa, Macau, China
| | - Volker R. Zschorlich
- Department of Movement Science, Institute of Sport Science, University of Rostock, 18057 Rostock, Germany
| | - Liye Zou
- Lifestyle (Mind-Body Movement) Research Center, College of Sports Science, Shenzhen University, Shenzhen 518060, China
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20
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Hyett MP, Bank SR, Lipp OV, Erceg-Hurn DM, Alvares GA, Maclaine E, Puckridge E, Hayes S, McEvoy PM. Attenuated Psychophysiological Reactivity following Single-Session Group Imagery Rescripting versus Verbal Restructuring in Social Anxiety Disorder: Results from a Randomized Controlled Trial. PSYCHOTHERAPY AND PSYCHOSOMATICS 2019; 87:340-349. [PMID: 30380535 DOI: 10.1159/000493897] [Citation(s) in RCA: 13] [Impact Index Per Article: 2.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Subscribe] [Scholar Register] [Received: 03/13/2018] [Accepted: 09/17/2018] [Indexed: 12/28/2022]
Abstract
BACKGROUND The effectiveness of psychotherapies for social anxiety disorder (SAD) is typically evaluated using self- and clinician-reported symptom change, while biomarkers of treatment response are rarely measured. The current study aimed to compare biomarkers of response following two brief group interventions for SAD. METHODS This randomized controlled trial evaluated the effectiveness of single-session group interventions for SAD (n = 58) - imagery rescripting (IR) and verbal restructuring (VR) versus waitlist control (WC). The IR intervention guided participants to rescript autobiographical memories through visualization whilst the VR intervention focused on thought challenging. Trial outcomes included change in psychophysiological reactivity (heart rate variability (HRV) and electrodermal responding) to social stress, and symptom-based measures (social interaction anxiety, negative self-portrayal, cognitive avoidance, repetitive negative thinking, memory modification, anxious behaviors). RESULTS Psychophysiological reactivity was selectively attenuated following IR treatment, compared to VR and WC groups. The specific influence of the imagery-based intervention in modulating autonomic reactivity was evident across HRV parameters, including the standard deviation of intervals between heartbeats (IR vs. WC, d = 0.67, p = 0.021; IR vs. VR, d = 0.58, p = 0.041), and high frequency power - an indicator of parasympathetically mediated emotion regulation (IR vs. WC, d = 0.75, p = 0.034; IR vs. VR, d = 0.95, p = 0.006). Few group differences were observed across self-report measures. CONCLUSION The current study highlights the specificity of brief imagery-based interventions in influencing psychophysiological reactivity in SAD and establishes the sensitivity of objective markers of treatment response in quantifying change over symptom-based measurements.
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Affiliation(s)
- Matthew P Hyett
- School of Psychology, Curtin University, Perth, Washington, Australia
| | - Samantha R Bank
- School of Psychology, Curtin University, Perth, Washington, Australia.,Centre for Clinical Interventions, Perth, Washington, Australia
| | - Ottmar V Lipp
- School of Psychology, Curtin University, Perth, Washington, Australia
| | - David M Erceg-Hurn
- School of Psychology, Curtin University, Perth, Washington, Australia.,Centre for Clinical Interventions, Perth, Washington, Australia
| | - Gail A Alvares
- Telethon Kids Institute, University of Western Australia, Perth, Washington, Australia
| | - Ellen Maclaine
- School of Psychology, Curtin University, Perth, Washington, Australia
| | - Emily Puckridge
- School of Psychology, Curtin University, Perth, Washington, Australia
| | - Sarra Hayes
- School of Psychology, Curtin University, Perth, Washington, Australia
| | - Peter M McEvoy
- School of Psychology, Curtin University, Perth, Washington, .,Centre for Clinical Interventions, Perth, Washington,
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21
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Meng K, Reusch A, Musekamp G, Seekatz B, Zietz B, Steimann G, Altstidl R, Haug G, Worringen U, Faller H. Self-management education for rehabilitation inpatients: A cluster-randomized controlled trial. PATIENT EDUCATION AND COUNSELING 2018; 101:1630-1638. [PMID: 29627267 DOI: 10.1016/j.pec.2018.03.027] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Received: 01/08/2018] [Revised: 03/06/2018] [Accepted: 03/29/2018] [Indexed: 06/08/2023]
Abstract
OBJECTIVE To evaluate generic self-management modules (SelMa) as an adjunct to disease-specific educational programs during inpatient medical rehabilitation. METHODS A bi-center cluster-randomized controlled trial with 698 patients with coronary artery disease, metabolic syndrome, or inflammatory bowel disease was conducted. We compared two versions of SelMa, a group with 3 h or a lecture with 1 h, respectively, in addition to disease-related patient education, to usual care (only disease-related education). SelMa aims at providing skills that may help implementing health behavior. The primary outcomes were goal setting and behavior planning at discharge and goal attainment and health behavior at 6- and 12-months follow-up. Secondary outcomes included motivation, knowledge and self-management competences. RESULTS At discharge, SelMa group, but not SelMa lecture, proved superior to usual care regarding goal setting (p = 0.007, d = 0.26), but not behavior planning (p = 0.37, d = 0.09). Significant effects were also observed on several secondary outcomes. At later follow-up, however, no effects on primary outcomes emerged. Participants' satisfaction was higher in the group than the lecture format. CONCLUSIONS These short modules did not succeed in improving self-management skills in the long-term. PRACTICE IMPLICATIONS A self-management group may foster self-management skills in short term. Interventions should be developed to increase sustainability of effects.
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Affiliation(s)
- Karin Meng
- Department of Medical Psychology, Medical Sociology, and Rehabilitation Sciences, University of Würzburg, Würzburg, Germany.
| | - Andrea Reusch
- Department of Medical Psychology, Medical Sociology, and Rehabilitation Sciences, University of Würzburg, Würzburg, Germany
| | - Gunda Musekamp
- Department of Medical Psychology, Medical Sociology, and Rehabilitation Sciences, University of Würzburg, Würzburg, Germany
| | - Bettina Seekatz
- Department of Medical Psychology, Medical Sociology, and Rehabilitation Sciences, University of Würzburg, Würzburg, Germany
| | | | | | - Robert Altstidl
- Rehabilitation Center Bayerisch Gmain, Bayerisch Gmain, Germany
| | - Günter Haug
- Rehabilitation Center Bayerisch Gmain, Bayerisch Gmain, Germany
| | | | - Hermann Faller
- Department of Medical Psychology, Medical Sociology, and Rehabilitation Sciences, University of Würzburg, Würzburg, Germany
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22
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Can a Lifestyle Intervention Increase Active Transportation in Women Aged 55-70 years? Secondary Outcomes From a Pilot Randomized Controlled Trial. J Phys Act Health 2018; 15:411-416. [PMID: 29570005 DOI: 10.1123/jpah.2016-0348] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/18/2022]
Abstract
BACKGROUND Physical activity confers many health benefits to older adults, and adopting activity into daily life routines may lead to better uptake. The purpose of this study was to test the effect of a lifestyle intervention to increase daily physical activity in older women through utilitarian walking and use of public transportation. METHODS In total, 25 inactive women with mean age (SD) of 64.1 (4.6) years participated in this pilot randomized controlled trial [intervention (n = 13) and control (n = 12)]. Seven-day travel diaries (trips per week) and the International Physical Activity Questionnaire (minutes per week) were collected at baseline, 3, and 6 months. RESULTS At 3 months, intervention participants reported 9 walking trips per week and 643.5 minutes per week of active transportation, whereas control participants reported 4 walking trips per week and 49.5 minutes per week of active transportation. Adjusting for baseline values, there were significant group differences favoring Everyday Activity Supports You for walking trips per week [4.6 (0.5 to 9.4); P = .04] and active transportation minutes per week [692.2 (36.1 to 1323.5); P = .05]. At 6 months, significant group differences were observed in walking trips per week [6.1 (1.9 to 11.4); P = .03] favoring the intervention (9 vs 2 trips per week). CONCLUSION Given these promising findings, the next step is to test Everyday Activity Supports You model's effectiveness to promote physical activity in older women within a larger study.
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Prieske O, Krüger T, Aehle M, Bauer E, Granacher U. Effects of Resisted Sprint Training and Traditional Power Training on Sprint, Jump, and Balance Performance in Healthy Young Adults: A Randomized Controlled Trial. Front Physiol 2018; 9:156. [PMID: 29551981 PMCID: PMC5840954 DOI: 10.3389/fphys.2018.00156] [Citation(s) in RCA: 8] [Impact Index Per Article: 1.1] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/06/2017] [Accepted: 02/15/2018] [Indexed: 11/30/2022] Open
Abstract
Power training programs have proved to be effective in improving components of physical fitness such as speed. According to the concept of training specificity, it was postulated that exercises must attempt to closely mimic the demands of the respective activity. When transferring this idea to speed development, the purpose of the present study was to examine the effects of resisted sprint (RST) vs. traditional power training (TPT) on physical fitness in healthy young adults. Thirty-five healthy, physically active adults were randomly assigned to a RST (n = 10, 23 ± 3 years), a TPT (n = 9, 23 ± 3 years), or a passive control group (n = 16, 23 ± 2 years). RST and TPT exercised for 6 weeks with three training sessions/week each lasting 45-60 min. RST comprised frontal and lateral sprint exercises using an expander system with increasing levels of resistance that was attached to a treadmill (h/p/cosmos). TPT included ballistic strength training at 40% of the one-repetition-maximum for the lower limbs (e.g., leg press, knee extensions). Before and after training, sprint (20-m sprint), change-of-direction speed (T-agility test), jump (drop, countermovement jump), and balance performances (Y balance test) were assessed. ANCOVA statistics revealed large main effects of group for 20-m sprint velocity and ground contact time (0.81 ≤ d ≤ 1.00). Post-hoc tests showed higher sprint velocity following RST and TPT (0.69 ≤ d ≤ 0.82) when compared to the control group, but no difference between RST and TPT. Pre-to-post changes amounted to 4.5% for RST [90%CI: (-1.1%;10.1%), d = 1.23] and 2.6% for TPT [90%CI: (0.4%;4.8%), d = 1.59]. Additionally, ground contact times during sprinting were shorter following RST and TPT (0.68 ≤ d ≤ 1.09) compared to the control group, but no difference between RST and TPT. Pre-to-post changes amounted to -6.3% for RST [90%CI: (-11.4%;-1.1%), d = 1.45) and -2.7% for TPT [90%CI: (-4.2%;-1.2%), d = 2.36]. Finally, effects for change-of-direction speed, jump, and balance performance varied from small-to-large. The present findings indicate that 6 weeks of RST and TPT produced similar effects on 20-m sprint performance compared with a passive control in healthy and physically active, young adults. However, no training-related effects were found for change-of-direction speed, jump and balance performance. We conclude that both training regimes can be applied for speed development.
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Affiliation(s)
- Olaf Prieske
- Division of Training and Movement Sciences, Research Focus Cognition Sciences, University of Potsdam, Potsdam, Germany
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Sweet SN, Rocchi M, Arbour-Nicitopoulos K, Kairy D, Fillion B. A Telerehabilitation Approach to Enhance Quality of Life Through Exercise Among Adults With Paraplegia: Study Protocol. JMIR Res Protoc 2017; 6:e202. [PMID: 29051134 PMCID: PMC5668635 DOI: 10.2196/resprot.8047] [Citation(s) in RCA: 9] [Impact Index Per Article: 1.1] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/15/2017] [Revised: 08/16/2017] [Accepted: 09/06/2017] [Indexed: 11/28/2022] Open
Abstract
Background Despite compelling evidence linking physical activity and quality of life among adults with spinal cord injury (SCI), exercise participation rates are extremely low in this population. Unfortunately, a lack of behavioral exercise interventions, in particular theory-based randomized controlled trials (RCT), exists within the SCI literature. A pilot RCT is needed to first examine the feasibility to conduct such interventions and determine the appropriate effect size to inform future full-scale interventions. Objective The overall goal of this pilot RCT is to test an 8-week innovative, video-based telerehabilitation intervention based on self-determination theory and aimed at enhancing the basic psychological needs, motivation, exercise participation, and quality of life‒related outcomes of adults with paraplegia. The objectives are to (1) determine if individuals in the intervention group have greater increases in their basic psychological needs and autonomous motivation and a decrease in controlled motivation compared to the control group, (2) determine whether the intervention group reports greater increases in exercise participation and quality of life‒related variables (eg, life satisfaction, participation in daily/social activities, depressive symptoms) compared to the control group, and (3) examine if adults with paraplegia who received the intervention report improved scores on psychosocial predictors of exercise (eg, action planning) and well-being (eg, positive affect) compared to the control group. We also aimed to examine the implementation characteristics of the intervention (eg, satisfaction with the technology, counselor’s ability to foster the psychological needs). Methods Adults with paraplegia (N=24) living in the community will be recruited. All participants will be invited to complete assessments of their psychological needs, motivation, exercise, and quality of life‒related variables at three time points (baseline, 6, and 10 weeks). Following the baseline assessment, participants will be randomly assigned to the intervention or control group. Participants in the intervention group will participate in 8 weekly, 1-hour video-based telerehabilitation sessions with a trained physical activity counselor, while participants in the control group will be asked to continue with their regular routine. Results We expect higher ratings of the basic psychological needs and autonomous motivation and lower scores for controlled motivation for the intervention group compared to the control group (Objective 1). We also expect that our video-based intervention will have moderate effects on exercise participation, as well as small-to-moderate positive effects on the quality of life‒related variables (Objective 2). Finally, we expect the intervention to have a small positive effect on psychosocial predictors of physical activity and well-being (Objective 3). Conclusions We anticipate that the results will show that the intervention is appropriate for adults with paraplegia and feasible to test in a full-scale RCT. Trial Registration ClinicalTrials.gov NCT02833935; https://clinicaltrials.gov/ct2/show/NCT02833935 (Archived by WebCite at http://www.webcitation.org/6u8U9x2yt)
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Affiliation(s)
- Shane Norman Sweet
- Center for Interdisciplinary Research in Rehabilitation of Greater Montreal (CRIR), Department of Kinesiology and Physical Education, McGill University, Montreal, QC, Canada
| | - Meredith Rocchi
- Center for Interdisciplinary Research in Rehabilitation of Greater Montreal (CRIR), Department of Kinesiology and Physical Education, McGill University, Montreal, QC, Canada
| | | | - Dahlia Kairy
- Center for Interdisciplinary Research in Rehabilitation of Greater Montreal (CRIR), École de réadaptation, Université de Montréal, Montreal, QC, Canada
| | - Brigitte Fillion
- Center for Interdisciplinary Research in Rehabilitation of Greater Montreal (CRIR), Centre de réadaptation Lucie-Bruneau, Centre intégré universitaire de santé et de services sociaux (CIUSSS) du Centre-Sud-de-l'Île-de-Montréal, Montreal, QC, Canada
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Arbour-Nicitopoulos KP, Sweet SN, Lamontagne ME, Ginis KAM, Jeske S, Routhier F, Latimer-Cheung AE. A randomized controlled trial to test the efficacy of the SCI Get Fit Toolkit on leisure-time physical activity behaviour and social-cognitive processes in adults with spinal cord injury. Spinal Cord Ser Cases 2017; 3:17044. [PMID: 28794901 DOI: 10.1038/scsandc.2017.44] [Citation(s) in RCA: 5] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/04/2016] [Revised: 05/31/2017] [Accepted: 06/27/2017] [Indexed: 11/09/2022] Open
Abstract
STUDY DESIGN Single blind, two-group randomized controlled trial. OBJECTIVES To evaluate the efficacy of the SCI Get Fit Toolkit delivered online on theoretical constructs and moderate-to-vigorous physical activity (MVPA) among adults with SCI. SETTING Ontario and Quebec, Canada. ELIGIBILITY Inactive, English- and French-speaking Canadian adults with traumatic SCI with Internet access, and no self-reported cognitive or memory impairments. METHODS Participants (N=90 Mage=48.12±11.29 years; 79% male) were randomized to view the SCI Get Fit Toolkit or the Physical Activity Guidelines for adults with SCI (PAG-SCI) online. Primary (intentions) and secondary (outcome expectancies, self-efficacy, planning and MVPA behaviour) outcomes were assessed over a 1-month period. RESULTS Of the 90 participants randomized, 77 were included in the analyses. Participants viewed the experimental stimuli only briefly, reading the 4-page toolkit for approximately 2.5 min longer than the 1-page guideline document. No condition effects were found for intentions, outcome expectancies, self-efficacy, and planning (ΔR2⩽0.03). Individuals in the toolkit condition were more likely to participate in at least one bout of 20 min of MVPA behaviour at 1-week post-intervention compared to individuals in the guidelines condition (OR=3.54, 95% CI=0.95, 13.17). However, no differences were found when examining change in weekly minutes of MVPA or comparing whether participants met the PAG-SCI. CONCLUSIONS No firm conclusions can be made regarding the impact of the SCI Get Fit Toolkit in comparison to the PAG-SCI on social cognitions and MVPA behaviour. The limited online access to this resource may partially explain these null findings.
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Affiliation(s)
| | - Shane N Sweet
- Department of Kinesiology and Physical Education, McGill University, Montreal, Quebec, Canada.,Center for Interdisciplinary Research in Rehabilitation of Greater Montreal, Montreal, Quebec, Canada
| | - Marie-Eve Lamontagne
- Center for Interdisciplinary Research in Rehabilitation and Social Integration, Institut de Rédadaptation en Déficience Physique de Québec, Centre Intégré Universitaire de Santé et de Services Sociaux de la Capitale-Nationale, Montreal, Quebec, Canada.,Faculty of Medicine, Department of Rehabilitation, Université Laval, Quebec City, Quebec, Canada
| | - Kathleen A Martin Ginis
- School of Health and Exercise Sciences, University of British Columbia, Okanagan, Kelowna, British Columbia, Canada.,International Collaboration on Repair Discoveries (ICORD), Vancouver, British Columbia, Canada
| | - Samantha Jeske
- Faculty of Kinesiology and Physical Education, University of Toronto, Toronto, Ontario, Canada
| | - François Routhier
- Center for Interdisciplinary Research in Rehabilitation and Social Integration, Institut de Rédadaptation en Déficience Physique de Québec, Centre Intégré Universitaire de Santé et de Services Sociaux de la Capitale-Nationale, Montreal, Quebec, Canada.,Faculty of Medicine, Department of Rehabilitation, Université Laval, Quebec City, Quebec, Canada
| | - Amy E Latimer-Cheung
- School of Kinesiology and Health Studies, Queen's University, Kingston, Ontario, Canada
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Aoyama Y, Uchida H, Sugi Y, Kawakami A, Fujii M, Kiso K, Kono R, Takebayashi T, Hirao K. Immediate effect of subliminal priming with positive reward stimuli on standing balance in healthy individuals: A randomized controlled trial. Medicine (Baltimore) 2017; 96:e7494. [PMID: 28700496 PMCID: PMC5515768 DOI: 10.1097/md.0000000000007494] [Citation(s) in RCA: 6] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/26/2022] Open
Abstract
BACKGROUND Information received subconsciously can influence exercise performance; however, it remains unclear whether subliminal or supraliminal reward is more effective in improving standing balance ability when priming stimuli are subconsciously delivered. The present study aimed to compare the effects of subliminal priming-plus-subliminal reward stimuli (experimental) with subliminal priming-plus-supraliminal reward stimuli (control) on standing balance ability. METHODS This was a single-blind (outcome assessor), parallel-group, randomized controlled trial involving healthy young adults recruited from a university in Japan. Assessments were conducted at baseline and immediately after intervention. The primary outcome was the functional reach test (FRT) measurement. The secondary outcome was one-leg standing time (OLST) with eyes closed. Of the 52 participants screened, 25 were randomly assigned to experimental and control groups each. RESULTS Both interventions were effective for improving the FRT between the baseline and intervention; however, smaller improvements were observed in the experimental group. We found a large between-groups effect size immediately after the intervention for the FRT (d = -0.92). In contrast, there were no differences in improvements in OLST between the 2 groups (d = -0.06); furthermore, neither intervention was found to be effective for this parameter. CONCLUSION We concluded that subliminal priming with conscious reward stimuli results in improvements in immediate-term forward reach ability, which is superior to that achieved by subliminal priming with subconscious reward stimuli.
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Mothes H, Leukel C, Seelig H, Fuchs R. Do placebo expectations influence perceived exertion during physical exercise? PLoS One 2017; 12:e0180434. [PMID: 28662168 PMCID: PMC5491246 DOI: 10.1371/journal.pone.0180434] [Citation(s) in RCA: 13] [Impact Index Per Article: 1.6] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/02/2017] [Accepted: 05/26/2017] [Indexed: 11/19/2022] Open
Abstract
This study investigates the role of placebo expectations in individuals’ perception of exertion during acute physical exercise. Building upon findings from placebo and marketing research, we examined how perceived exertion is affected by expectations regarding a) the effects of exercise and b) the effects of the exercise product worn during the exercise. We also investigated whether these effects are moderated by physical self-concept. Seventy-eight participants conducted a moderate 30 min cycling exercise on an ergometer, with perceived exertion (RPE) measured every 5 minutes. Beforehand, each participant was randomly assigned to 1 of 4 conditions and watched a corresponding film clip presenting “scientific evidence” that the exercise would or would not result in health benefits and that the exercise product they were wearing (compression garment) would additionally enhance exercise benefits or would only be worn for control purposes. Participants’ physical self-concept was assessed via questionnaire. Results partially demonstrated that participants with more positive expectations experienced reduced perceived exertion during the exercise. Furthermore, our results indicate a moderator effect of physical self-concept: Individuals with a high physical self-concept benefited (in terms of reduced perceived exertion levels) in particular from an induction of generally positive expectations. In contrast, individuals with a low physical self-concept benefited when positive expectations were related to the exercise product they were wearing. In sum, these results suggest that placebo expectations may be a further, previously neglected class of psychological factors that influence the perception of exertion.
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Affiliation(s)
- Hendrik Mothes
- Department of Sports Science, University of Freiburg, Schwarzwaldstrasse 175, Freiburg, Germany
- * E-mail:
| | - Christian Leukel
- Department of Sports Science, University of Freiburg, Schwarzwaldstrasse 175, Freiburg, Germany
- Bernstein Center Freiburg, University of Freiburg, Hansastrasse 9a, Freiburg, Germany
| | - Harald Seelig
- Department of Sport, Exercise and Health, University of Basel, Birsstrasse 320 B, Basel, Switzerland
| | - Reinhard Fuchs
- Department of Sports Science, University of Freiburg, Schwarzwaldstrasse 175, Freiburg, Germany
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Meng K, Peters S, Faller H. Effectiveness of a standardized back school program for patients with chronic low back pain after implementation in routine rehabilitation care. PATIENT EDUCATION AND COUNSELING 2017; 100:1161-1168. [PMID: 28110954 DOI: 10.1016/j.pec.2017.01.011] [Citation(s) in RCA: 17] [Impact Index Per Article: 2.1] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Received: 03/09/2016] [Revised: 12/22/2016] [Accepted: 01/13/2017] [Indexed: 05/06/2023]
Abstract
OBJECTIVE To evaluate the effectiveness of a standardized, patient-oriented, biopsychosocial back school after implementation in inpatient orthopedic rehabilitation. METHODS A multi-center, quasi-experimental controlled study of patients with low back pain (n=535) was conducted. Patients in the control group received the traditional back school before implementation of the new program (usual care); patients in the intervention group received the new standardized back school after implementation into routine care. Patients' illness knowledge and conduct of back exercises (primary outcomes) and secondary self-management outcomes and treatment satisfaction were obtained at admission, discharge, and 6 and 12 months after rehabilitation. RESULTS We found a significant small between-group intervention effect on patients' illness knowledge in medium- to long term (6 months: η2=0.015; 12 months: η2=0.013). There were trends for effects on conduct of back exercises among men (6 and 12 months: η2=0.008 both). Furthermore, significant small effects were observed for treatment satisfaction at discharge and physical activity after 6 months. CONCLUSIONS The standardized back school seems to be more effective in certain outcomes than a usual care program despite heterogeneous program implementation. PRACTICE IMPLICATIONS Further dissemination within orthopedic rehabilitation may be encouraged to foster self-management outcomes.
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Affiliation(s)
- Karin Meng
- Department of Medical Psychology, Medical Sociology, and Rehabilitation Sciences, University of Würzburg, Würzburg, Germany.
| | - Stefan Peters
- Department of Medical Psychology, Medical Sociology, and Rehabilitation Sciences, University of Würzburg, Würzburg, Germany
| | - Hermann Faller
- Department of Medical Psychology, Medical Sociology, and Rehabilitation Sciences, University of Würzburg, Würzburg, Germany
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Shayeghian Z, Hassanabadi H, Aguilar-Vafaie ME, Amiri P, Besharat MA. A Randomized Controlled Trial of Acceptance and Commitment Therapy for Type 2 Diabetes Management: The Moderating Role of Coping Styles. PLoS One 2016; 11:e0166599. [PMID: 27907074 PMCID: PMC5132195 DOI: 10.1371/journal.pone.0166599] [Citation(s) in RCA: 42] [Impact Index Per Article: 4.7] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/24/2016] [Accepted: 10/29/2016] [Indexed: 11/25/2022] Open
Abstract
Background and Aim Evidence of the efficacy of existing psychological interventions for self-management in diabetes is limited. The current study aimed at assessing the effects of group-based ACT on self-management of patients with T2DM, considering the moderating role of coping styles. Methods One hundred and six patients with type 2 diabetes were randomly assigned either to the education alone (n = 53) or to a combination of education and group-based acceptance and commitment therapy (n = 53) over a period of 10 sessions. In each group, 50 participants completed a 3 month follow-up assessment. Results After 3 months, compared to patients who received education alone, those in the group-based acceptance and commitment therapy condition were more likely to use effective coping strategies, reported better diabetes self-care, and optimum glycated hemoglobin (HbA1C) levels in the target range. Conclusions Consideration of the role of coping style for a more accurate evaluation of the effects of acceptance and commitment therapy may be a useful addition to services provided for patients with type 2 diabetes.
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Affiliation(s)
- Zeinab Shayeghian
- Research Center for Social Determinants of Endocrine Health & Obesity Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran
| | | | | | - Parisa Amiri
- Research Center for Social Determinants of Endocrine Health & Obesity Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran
- * E-mail:
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Expectations affect psychological and neurophysiological benefits even after a single bout of exercise. J Behav Med 2016; 40:293-306. [PMID: 27506909 DOI: 10.1007/s10865-016-9781-3] [Citation(s) in RCA: 30] [Impact Index Per Article: 3.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/30/2016] [Accepted: 08/02/2016] [Indexed: 10/21/2022]
Abstract
The study investigated whether typical psychological, physiological, and neurophysiological changes from a single exercise are affected by one's beliefs and expectations. Seventy-six participants were randomly assigned to four groups and saw different multimedia presentations suggesting that the subsequent exercise (moderate 30 min cycling) would result in more or less health benefits (induced expectations). Additionally, we assessed habitual expectations reflecting previous experience and beliefs regarding exercise benefits. Participants with more positive habitual expectations consistently demonstrated both greater psychological benefits (more enjoyment, mood increase, and anxiety reduction) and greater increase of alpha-2 power, assessed with electroencephalography. Manipulating participants' expectations also resulted in largely greater increases of alpha-2 power, but not in more psychological exercise benefits. On the physiological level, participants decreased their blood pressure after exercising, but this was independent of their expectations. These results indicate that habitual expectations in particular affect exercise-induced psychological and neurophysiological changes in a self-fulfilling manner.
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Meng K, Musekamp G, Schuler M, Seekatz B, Glatz J, Karger G, Kiwus U, Knoglinger E, Schubmann R, Westphal R, Faller H. The impact of a self-management patient education program for patients with chronic heart failure undergoing inpatient cardiac rehabilitation. PATIENT EDUCATION AND COUNSELING 2016; 99:1190-1197. [PMID: 26898600 DOI: 10.1016/j.pec.2016.02.010] [Citation(s) in RCA: 39] [Impact Index Per Article: 4.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Received: 11/20/2015] [Revised: 01/27/2016] [Accepted: 02/13/2016] [Indexed: 06/05/2023]
Abstract
OBJECTIVE To evaluate a patient-centred self-management educational group program for patients with chronic systolic heart failure as compared to usual care education during inpatient cardiac rehabilitation. METHODS A multicentre cluster randomized controlled trial of 475 patients was conducted. In the intervention condition, patients received the new self-management educational group program whereas in the control condition, patients received a short lecture-based educational program (usual care). The primary outcome was patients' self-reported self-management competence. Secondary outcomes included self-management health behaviour, health-related quality of life, and treatment satisfaction. Patients completed self-reported outcome measures at admission, discharge, and after 6 and 12 months. RESULTS There was a significant small between-group intervention effect on certain dimension of patients' self-management competence (self-monitoring and insight) in short term (p<0.05). Furthermore, significant small effects were observed for treatment satisfaction at discharge as well as symptom monitoring after 6 months (p<0.05) and by trend on symptom monitoring and physical activity after 12 months. CONCLUSIONS The patient-centred self-management program might be more effective in certain self-management outcomes than a usual care education in both short-term and long-term periods. PRACTICE IMPLICATIONS Therefore, such programs may be considered for dissemination within cardiac rehabilitation.
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Affiliation(s)
- Karin Meng
- Department of Medical Psychology, Medical Sociology, and Rehabilitation Sciences, University of Wuerzburg, Würzburg, Germany.
| | - Gunda Musekamp
- Department of Medical Psychology, Medical Sociology, and Rehabilitation Sciences, University of Wuerzburg, Würzburg, Germany
| | - Michael Schuler
- Department of Medical Psychology, Medical Sociology, and Rehabilitation Sciences, University of Wuerzburg, Würzburg, Germany
| | - Bettina Seekatz
- Department of Medical Psychology, Medical Sociology, and Rehabilitation Sciences, University of Wuerzburg, Würzburg, Germany
| | | | - Gabriele Karger
- Rehabilitation Hospital Heidelberg-Königstuhl, Heidelberg, Germany
| | - Ulrich Kiwus
- Rehabilitation Center Bad Nauheim-Rehabilitation Hospital Wetterau, Bad Nauheim, Germany
| | - Ernst Knoglinger
- Rehabilitation Hospital Kirchberg-Klinik, Bad Lauterberg, Germany
| | | | - Ronja Westphal
- Segeberger Kliniken GmbH, Rehabilitation Hospital, Bad Segeberg, Germany
| | - Hermann Faller
- Department of Medical Psychology, Medical Sociology, and Rehabilitation Sciences, University of Wuerzburg, Würzburg, Germany
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Musekamp G, Gerlich C, Ehlebracht-König I, Faller H, Reusch A. Evaluation of a self-management patient education program for patients with fibromyalgia syndrome: study protocol of a cluster randomized controlled trial. BMC Musculoskelet Disord 2016; 17:55. [PMID: 26842871 PMCID: PMC4738802 DOI: 10.1186/s12891-016-0903-4] [Citation(s) in RCA: 9] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/22/2015] [Accepted: 01/26/2016] [Indexed: 11/10/2022] Open
Abstract
BACKGROUND Fibromyalgia syndrome (FMS) is a complex chronic condition that makes high demands on patients' self-management skills. Thus, patient education is considered an important component of multimodal therapy, although evidence regarding its effectiveness is scarce. The main objective of this study is to assess the effectiveness of an advanced self-management patient education program for patients with FMS as compared to usual care in the context of inpatient rehabilitation. METHODS/DESIGN We conducted a multicenter cluster randomized controlled trial in 3 rehabilitation clinics. Clusters are groups of patients with FMS consecutively recruited within one week after admission. Patients of the intervention group receive the advanced multidisciplinary self-management patient education program (considering new knowledge on FMS, with a focus on transfer into everyday life), whereas patients in the control group receive standard patient education programs including information on FMS and coping with pain. A total of 566 patients are assessed at admission, at discharge and after 6 and 12 months, using patient reported questionnaires. Primary outcomes are patients' disease- and treatment-specific knowledge at discharge and self-management skills after 6 months. Secondary outcomes include satisfaction, attitudes and coping competences, health-promoting behavior, psychological distress, health impairment and participation. Treatment effects between groups are evaluated using multilevel regression analysis adjusting for baseline values. DISCUSSION The study evaluates the effectiveness of a self-management patient education program for patients with FMS in the context of inpatient rehabilitation in a cluster randomized trial. Study results will show whether self-management patient education is beneficial for this group of patients. TRIAL REGISTRATION German Clinical Trials Register, DRKS00008782 , Registered 8 July 2015.
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Affiliation(s)
- Gunda Musekamp
- Department of Medical Psychology and Psychotherapy, Medical Sociology and Rehabilitation Sciences, University of Würzburg, Klinikstr. 3, D-97070, Würzburg, Germany.
| | - Christian Gerlich
- Department of Medical Psychology and Psychotherapy, Medical Sociology and Rehabilitation Sciences, University of Würzburg, Klinikstr. 3, D-97070, Würzburg, Germany.
| | | | - Hermann Faller
- Department of Medical Psychology and Psychotherapy, Medical Sociology and Rehabilitation Sciences, University of Würzburg, Klinikstr. 3, D-97070, Würzburg, Germany.
| | - Andrea Reusch
- Department of Medical Psychology and Psychotherapy, Medical Sociology and Rehabilitation Sciences, University of Würzburg, Klinikstr. 3, D-97070, Würzburg, Germany.
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Behrens M, Mau-Moeller A, Mueller K, Heise S, Gube M, Beuster N, Herlyn PK, Fischer DC, Bruhn S. Plyometric training improves voluntary activation and strength during isometric, concentric and eccentric contractions. J Sci Med Sport 2016; 19:170-6. [DOI: 10.1016/j.jsams.2015.01.011] [Citation(s) in RCA: 34] [Impact Index Per Article: 3.8] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/16/2014] [Revised: 01/16/2015] [Accepted: 01/28/2015] [Indexed: 11/16/2022]
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Behrens M, Weippert M, Wassermann F, Bader R, Bruhn S, Mau-Moeller A. Neuromuscular function and fatigue resistance of the plantar flexors following short-term cycling endurance training. Front Physiol 2015; 6:145. [PMID: 26029114 PMCID: PMC4429572 DOI: 10.3389/fphys.2015.00145] [Citation(s) in RCA: 7] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/23/2015] [Accepted: 04/21/2015] [Indexed: 12/02/2022] Open
Abstract
Previously published studies on the effect of short-term endurance training on neuromuscular function of the plantar flexors have shown that the H-reflex elicited at rest and during weak voluntary contractions was increased following the training regime. However, these studies did not test H-reflex modulation during isometric maximum voluntary contraction (iMVC) and did not incorporate a control group in their study design to compare the results of the endurance training group to individuals without the endurance training stimulus. Therefore, this randomized controlled study was directed to investigate the neuromuscular function of the plantar flexors at rest and during iMVC before and after 8 weeks of cycling endurance training. Twenty-two young adults were randomly assigned to an intervention group and a control group. During neuromuscular testing, rate of torque development, isometric maximum voluntary torque and muscle activation were measured. Triceps surae muscle activation and tibialis anterior muscle co-activation were assessed by normalized root mean square of the EMG signal during the initial phase of contraction (0–100, 100–200 ms) and iMVC of the plantar flexors. Furthermore, evoked spinal reflex responses of the soleus muscle (H-reflex evoked at rest and during iMVC, V-wave), peak twitch torques induced by electrical stimulation of the posterior tibial nerve at rest and fatigue resistance were evaluated. The results indicate that cycling endurance training did not lead to a significant change in any variable of interest. Data of the present study conflict with the outcome of previously published studies that have found an increase in H-reflex excitability after endurance training. However, these studies had not included a control group in their study design as was the case here. It is concluded that short-term cycling endurance training does not necessarily enhance H-reflex responses and fatigue resistance.
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Affiliation(s)
- Martin Behrens
- Institute of Sport Science, University of Rostock Rostock, Germany
| | - Matthias Weippert
- Institute of Sport Science, University of Rostock Rostock, Germany ; Institute of Exercise Physiology and Public Health Rostock, Germany
| | | | - Rainer Bader
- Department of Orthopaedics, University Medicine Rostock Rostock, Germany
| | - Sven Bruhn
- Institute of Sport Science, University of Rostock Rostock, Germany
| | - Anett Mau-Moeller
- Department of Orthopaedics, University Medicine Rostock Rostock, Germany
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Alghamdi M, Hunt N, Thomas S. The effectiveness of Narrative Exposure Therapy with traumatised firefighters in Saudi Arabia: A randomized controlled study. Behav Res Ther 2015; 66:64-71. [DOI: 10.1016/j.brat.2015.01.008] [Citation(s) in RCA: 24] [Impact Index Per Article: 2.4] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/04/2014] [Revised: 12/26/2014] [Accepted: 01/25/2015] [Indexed: 11/30/2022]
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Behrens M, Mau-Moeller A, Wassermann F, Bader R, Bruhn S. Effect of balance training on neuromuscular function at rest and during isometric maximum voluntary contraction. Eur J Appl Physiol 2015; 115:1075-85. [DOI: 10.1007/s00421-014-3089-1] [Citation(s) in RCA: 11] [Impact Index Per Article: 1.1] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/04/2014] [Accepted: 12/17/2014] [Indexed: 10/24/2022]
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Kivi M, Eriksson MCM, Hange D, Petersson EL, Vernmark K, Johansson B, Björkelund C. Internet-based therapy for mild to moderate depression in Swedish primary care: short term results from the PRIM-NET randomized controlled trial. Cogn Behav Ther 2014; 43:289-98. [PMID: 24911260 PMCID: PMC4260664 DOI: 10.1080/16506073.2014.921834] [Citation(s) in RCA: 63] [Impact Index Per Article: 5.7] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/27/2022]
Abstract
Depression presents a serious condition for the individual and a major challenge to health care and society. Internet-based cognitive behavior therapy (ICBT) is a treatment option supported in several trials, but there is as yet a lack of effective studies of ICBT in "real world" primary care settings. We examined whether ICBT differed from treatment-as-usual (TAU) in reducing depressive symptoms after 3 months. TAU comprised of visits to general practitioner, registered nurse, antidepressant drugs, waiting list for, or psychotherapy, or combinations of these alternatives. Patients, aged ≥ 18 years, who tentatively met criteria for mild to moderate depression at 16 primary care centers in the south-western region of Sweden were recruited and then assessed in a diagnostic interview. A total of 90 patients were randomized to either TAU or ICBT. The ICBT treatment included interactive elements online, a workbook, a CD with mindfulness and acceptance exercises, and minimal therapist contact. The treatment period lasted for 12 weeks after which both groups were assessed. The main outcome measure was Beck Depression Inventory-II (BDI-II). Additional measures were Montgomery Åsberg Depression Rating Scale - self rating version (MADRS-S) and Beck Anxiety Inventory (BAI). The analyses revealed no significant difference between the two groups at post treatment, neither on BDI-II, MADRS-S, nor BAI. Twenty patients (56%) in the ICBT treatment completed all seven modules. Our findings suggest that ICBT may be successfully delivered in primary care and that the effectiveness, after 3 months, is at par with TAU.
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Affiliation(s)
- Marie Kivi
- a Department of Psychology , University of Gothenburg , Gothenburg , Sweden
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Meng K, Seekatz B, Haug G, Mosler G, Schwaab B, Worringen U, Faller H. Evaluation of a standardized patient education program for inpatient cardiac rehabilitation: impact on illness knowledge and self-management behaviors up to 1 year. HEALTH EDUCATION RESEARCH 2014; 29:235-246. [PMID: 24399262 DOI: 10.1093/her/cyt107] [Citation(s) in RCA: 20] [Impact Index Per Article: 1.8] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 06/03/2023]
Abstract
Patient education is an essential part of the treatment of coronary heart disease in cardiac rehabilitation. In Germany, no standardized and evaluated patient education programs for coronary heart disease have been available so far. In this article, we report the evaluation of a patient-oriented program. A multicenter quasi-experimental, sequential cohort design study of patients with coronary heart disease (n = 434) in inpatient cardiac rehabilitation was conducted. Intervention patients received the new patient-oriented program, control patients a traditional lecture-based program (usual care). Primary outcome illness knowledge and secondary behavioral and health outcomes were assessed at admission, discharge and 6- and 12-months follow-up. We found a significant, small between-group intervention effect in both patients' medical illness and treatment knowledge and behavior change knowledge at discharge (medical: η(2) = 0.013; behavior change: η(2) = 0.011) and after 12 months (medical: η(2) = 0.015). Furthermore, a significant, small effect was observed for physical activity after 12 months (η(2) = 0.011), but no effects on healthy diet and medication adherence emerged. Superiority of the patient-oriented educational program for patients with coronary heart disease was partially confirmed. The program produced improved illness knowledge and physical activity compared with usual care after 1 year.
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Affiliation(s)
- Karin Meng
- Department of Medical Psychology, Medical Sociology, and Rehabilitation Sciences, University of Würzburg, D-97070 Würzburg, Germany, Rehabilitation Center Bayerisch Gmain, D-83457 Bayerisch Gmain, Germany, Rehabilitation Hospital Höhenried, D-82347 Bernried, Germany, Curschmann Klinik, Rehabilitation Hospital, D-23669 Timmendorfer Strand, Germany and Department Rehabilitation, German Statutory Pension Insurance Scheme, D-10709 Berlin, Germany
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Dear BF, Titov N, Perry KN, Johnston L, Wootton BM, Terides MD, Rapee RM, Hudson JL. The Pain Course: a randomised controlled trial of a clinician-guided Internet-delivered cognitive behaviour therapy program for managing chronic pain and emotional well-being. Pain 2014; 154:942-50. [PMID: 23688830 DOI: 10.1016/j.pain.2013.03.005] [Citation(s) in RCA: 132] [Impact Index Per Article: 12.0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/27/2012] [Revised: 03/04/2013] [Accepted: 03/04/2013] [Indexed: 01/21/2023]
Abstract
The present study evaluated the efficacy of a clinician-guided Internet-delivered cognitive behaviour therapy (iCBT) program, the Pain Course, to reduce disability, anxiety, and depression associated with chronic pain. Sixty-three adults with chronic pain were randomised to either a Treatment Group or waitlist Control Group. Treatment consisted of 5 iCBT-based lessons, homework tasks, additional resources, weekly e-mail or telephone contact from a Clinical Psychologist, and automated e-mails. Twenty-nine of 31 Treatment Group participants completed the 5 lessons during the 8-week program, and posttreatment and 3-month follow-up data were collected from 30/31 and 29/31 participants, respectively. Treatment Group participants obtained significantly greater improvements than Control Group participants in levels of disability, anxiety, depression, and average pain levels at posttreatment. These improvements corresponded to small to large between-groups effect sizes (Cohen's d) at posttreatment for disability (d = .88), anxiety (d = .38), depression (d = .66), and average pain (d = .64), respectively. These outcomes were sustained at follow-up and participants rated the program as highly acceptable. Overall, the clinician spent a total mean time of 81.54 minutes (SD 30.91 minutes) contacting participants during the program. The results appear better than those reported in iCBT studies to date and provide support for the potential of clinician-guided iCBT in the treatment of disability, anxiety, and depression for people with chronic pain.
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Affiliation(s)
- Blake F Dear
- The Centre for Emotional Health, Department of Psychology, Macquarie University, Sydney, Australia.
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Koszycki D, Bilodeau C, Raab-Mayo K, Bradwejn J. A multifaith spiritually based intervention versus supportive therapy for generalized anxiety disorder: a pilot randomized controlled trial. J Clin Psychol 2013; 70:489-509. [PMID: 24114846 PMCID: PMC4282333 DOI: 10.1002/jclp.22052] [Citation(s) in RCA: 30] [Impact Index Per Article: 2.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/17/2022]
Abstract
OBJECTIVES We have previously reported that a multifaith spiritually based intervention (SBI) may have efficacy in the treatment of generalized anxiety disorder (GAD). This randomized pilot trial tested whether the SBI had greater efficacy than a nonspecific control condition in GAD. METHOD Twenty-three participants with GAD of at least moderate severity were randomized to 12 individual sessions of the SBI (n = 11) or supportive psychotherapy (SP)--our control condition (n = 12). RESULTS Intent-to-treat analysis revealed the SBI fared better than SP in decreasing blind clinician ratings of anxiety and illness severity and self-report worry and intolerance of uncertainty, with large between-group effect sizes. The SBI also produced greater changes in spiritual well-being. Results remained the same when supplementary analyses were performed on the completer sample. Treatment gains were maintained at 3-months follow-up. CONCLUSIONS This small pilot trial demonstrates that a nondenominational SBI has greater efficacy than a rigorous control in improving symptoms of GAD and enhancing spiritual well-being. These results are encouraging and further research on the efficacy of the SBI and its underlying mechanisms is warranted.
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Affiliation(s)
- Diana Koszycki
- Faculty of Education (Counselling), University of Ottawa, Ottawa, Ontario, Canada; Faculty of Medicine (Psychiatry), University of Ottawa, Ottawa, Ontario, Canada; Institut de Recherche de l'Hôpital Montfort, Ottawa, Ontario, Canada
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Meng K, Musekamp G, Seekatz B, Glatz J, Karger G, Kiwus U, Knoglinger E, Schubmann R, Westphal R, Faller H. Evaluation of a self-management patient education program for patients with chronic heart failure undergoing inpatient cardiac rehabilitation: study protocol of a cluster randomized controlled trial. BMC Cardiovasc Disord 2013; 13:60. [PMID: 23968340 PMCID: PMC3765303 DOI: 10.1186/1471-2261-13-60] [Citation(s) in RCA: 9] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/10/2013] [Accepted: 08/19/2013] [Indexed: 11/26/2022] Open
Abstract
Background Chronic heart failure requires a complex treatment regimen on a life-long basis. Therefore, self-care/self-management is an essential part of successful treatment and comprehensive patient education is warranted. However, specific information on program features and educational strategies enhancing treatment success is lacking. This trial aims to evaluate a patient-oriented and theory-based self-management educational group program as compared to usual care education during inpatient cardiac rehabilitation in Germany. Methods/Design The study is a multicenter cluster randomized controlled trial in four cardiac rehabilitation clinics. Clusters are patient education groups that comprise HF patients recruited within 2 weeks after commencement of inpatient cardiac rehabilitation. Cluster randomization was chosen for pragmatic reasons, i.e. to ensure a sufficient number of eligible patients to build large-enough educational groups and to prevent contamination by interaction of patients from different treatment allocations during rehabilitation. Rehabilitants with chronic systolic heart failure (n = 540) will be consecutively recruited for the study at the beginning of inpatient rehabilitation. Data will be assessed at admission, at discharge and after 6 and 12 months using patient questionnaires. In the intervention condition, patients receive the new patient-oriented self-management educational program, whereas in the control condition, patients receive a short lecture-based educational program (usual care). The primary outcome is patients’ self-reported self-management competence. Secondary outcomes include behavioral determinants and self-management health behavior (symptom monitoring, physical activity, medication adherence), health-related quality of life, and treatment satisfaction. Treatment effects will be evaluated separately for each follow-up time point using multilevel regression analysis, and adjusting for baseline values. Discussion This study evaluates the effectiveness of a comprehensive self-management educational program by a cluster randomized trial within inpatient cardiac rehabilitation in Germany. Furthermore, subgroup-related treatment effects will be explored. Study results will contribute to a better understanding of both the effectiveness and mechanisms of a self-management group program as part of cardiac rehabilitation. Trial registration German Clinical Trials Register: DRKS00004841; WHO International Clinical Trials: = DRKS00004841
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Carlbring P, Hägglund M, Luthström A, Dahlin M, Kadowaki Å, Vernmark K, Andersson G. Internet-based behavioral activation and acceptance-based treatment for depression: a randomized controlled trial. J Affect Disord 2013; 148:331-7. [PMID: 23357657 DOI: 10.1016/j.jad.2012.12.020] [Citation(s) in RCA: 114] [Impact Index Per Article: 9.5] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/08/2012] [Revised: 12/22/2012] [Accepted: 12/24/2012] [Indexed: 01/21/2023]
Abstract
BACKGROUND Internet-based cognitive behavior therapy for depression has been tested in several trials but there are no internet studies on behavioral activation (BA), and no studies on BA over the internet including components of acceptance and commitment therapy (ACT). The aim of this study was to develop and test the effects of internet-delivered BA combined with ACT against a waiting list control condition as a first test of the effects of treatment. METHODS Selection took place with a computerized screening interview and a subsequent semi-structured telephone interview. A total of 80 individuals from the general public were randomized to one of two conditions. The treatment lasted for 8 weeks after which both groups were assessed. We also included a 3 month follow-up. The treatment included interactive elements online and a CD-ROM for mindfulness and acceptance exercises. In addition, written support and feedback was given by a therapist every week. RESULTS Results at posttreatment showed a large between group effect size on the Beck Depression inventory II d=0.98 (95%CI=0.51-1.44). In the treated group 25% (10/40) reached remission defined as a BDI score ≤ 10 vs. 5% (2/40) in the control group. Results on secondary measures were smaller. While few dropped out from the study (N=2) at posttreatment, the average number of completed modules was M=5.1 out of the seven modules. LIMITATIONS The study only included a waiting-list comparison and it is not possible to determine which treatment components were the most effective. CONCLUSIONS We conclude that there is initial evidence that BA with components of ACT can be effective in reducing symptoms of depression.
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Affiliation(s)
- Per Carlbring
- Department of Psychology, Stockholm University, Stockholm, Sweden.
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Efficacy of combined atorvastatin and sildenafil in promoting recovery after ischemic stroke in mice. Am J Phys Med Rehabil 2013; 92:143-50. [PMID: 22854903 DOI: 10.1097/phm.0b013e3182643f1a] [Citation(s) in RCA: 8] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/24/2022]
Abstract
OBJECTIVE The aim of this study was to test the hypothesis that a combination of atorvastatin and sildenafil promotes recovery in an additive manner after ischemic stroke in mice. DESIGN Adult C57BL/6 mice (n = 67) were subjected to transient middle cerebral artery occlusion. Vehicle-control (H2O), atorvastatin (0.3 mg/kg), sildenafil (0.3 mg/kg), or combined atorvastatin (0.3 mg/kg) and sildenafil (0.3 mg/kg) were administrated via oral gavage daily for 6 days starting 24 hrs after ischemia. Behavioral studies including neurologic score and adhesive removal test were performed before surgery and on postoperative days 1 and 7; cylinder test was performed before surgery and on postoperative day 7. Mice were killed after 7 days and brain slices were stained with hematoxylin and eosin to measure the infarct volume. RESULTS The combination group performed significantly better in the adhesive removal test (mean ± SD) (50 ± 54 secs) as compared with the control group (147 ± 109 secs) (P < 0.05) and to atorvastatin (144 ± 102 secs) (P < 0.05) but did not show statistically significant improvement as compared with sildenafil (107 ± 115 secs) (P = 0.148). There were no significant differences among the groups in neurologic score and cylinder test. There was no significant difference in the infarct volume. CONCLUSIONS The data suggest that combined atorvastatin and sildenafil generates a better functional outcome as compared with atorvastatin-only treatment, but not sildenafil-only treatment, in one of multiple variables tested.
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Zang Y, Hunt N, Cox T. A randomised controlled pilot study: the effectiveness of narrative exposure therapy with adult survivors of the Sichuan earthquake. BMC Psychiatry 2013; 13:41. [PMID: 23363689 PMCID: PMC3570314 DOI: 10.1186/1471-244x-13-41] [Citation(s) in RCA: 56] [Impact Index Per Article: 4.7] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/23/2012] [Accepted: 01/15/2013] [Indexed: 11/10/2022] Open
Abstract
BACKGROUND Post-Traumatic Stress Disorder (PTSD) is a common psychological reaction after large-scale natural disasters. Given the number of people involved and shortage of resources in any major disaster, brief, pragmatic and easily trainable interventions are needed. The aim of this study is to evaluate the efficacy of Narrative Exposure Therapy (NET) as a short-term treatment for PTSD using Chinese earthquake survivors. METHODS A randomized waiting-list control pilot study was conducted between December 2009 and March 2010, at the site of the Sichuan earthquake in Beichuan County, China. Adult participants with newly diagnosed Post Traumatic Stress Disorder (PTSD) were randomly allocated to Narrative Exposure Therapy (NET) or a Waiting-List (WL) condition. The latter received NET treatment after a two-week waiting period. To compare the effectiveness of NET in traumatised earthquake survivors, both groups were assessed on PTSD symptoms, general mental health, anxiety and depression, social support, coping style and posttraumatic change before and after treatment and two months post treatment. RESULTS Adult participants (n=22) were randomly allocated to receive NET (n=11) or WL (n=11). Twenty two participants (11 in NET group, 11 in WL) were included in the analysis of primary outcomes. Compared with WL, NET showed significant reductions in PTSD symptoms, anxiety and depression, general mental stress and increased posttraumatic growth. The WL group later showed similar improvements after treatment. These changes remained stable for a two-month follow-up. Measures of social support and coping showed no stable effects. CONCLUSIONS NET is effective in treating post-earthquake traumatic symptoms in adult Chinese earthquake survivors. The findings help advance current knowledge in the management of PTSD after natural disasters and inform future research. Larger sample sizes are needed to extend the present findings. TRIAL REGISTRATION Chinese Clinical Trial Registry ChiCTR-TRC-12002473.
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Affiliation(s)
- Yinyin Zang
- Institute of Work, Health and Organisations, University of Nottingham, Nottingham, UK NG8 1BB
| | - Nigel Hunt
- Institute of Work, Health and Organisations, University of Nottingham, Nottingham, UK NG8 1BB
| | - Tom Cox
- Institute of Work, Health and Organisations, University of Nottingham, Nottingham, UK NG8 1BB
- School of Business, Economics & Informatics, Birkbeck University of London, London WC1, UK
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Edelman S, Mahoney AE, Cremer PD. Cognitive behavior therapy for chronic subjective dizziness: a randomized, controlled trial. Am J Otolaryngol 2012; 33:395-401. [PMID: 22104568 DOI: 10.1016/j.amjoto.2011.10.009] [Citation(s) in RCA: 69] [Impact Index Per Article: 5.3] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/09/2011] [Accepted: 10/08/2011] [Indexed: 02/07/2023]
Abstract
PURPOSE The aim of this study was to evaluate the effects of a brief cognitive behavior therapy (CBT) intervention on the physical symptoms, illness-related disability, and psychologic distress of patients with chronic subjective dizziness. MATERIALS AND METHODS Forty-one patients with chronic subjective dizziness referred by a neurootologic clinic were randomly assigned to immediate treatment or a wait-list control. Three weekly treatment sessions based on the CBT model of panic disorder, adapted for patients with dizziness, were administered by a clinical psychologist. Treatment included psychoeducation, behavioral experiments, exposure to feared stimuli, and attentional refocusing. Outcomes were measured on the Dizziness Handicap Inventory and the Depression, Anxiety and Stress Scales. Two further measures developed for this study; the Dizziness Symptoms Inventory and the Safety Behaviours Inventory were used to measure physical symptoms and safety behaviors. RESULTS The intervention was associated with significant reductions in disability on the Dizziness Handicap Inventory, reduced dizziness and related physical symptoms on the Dizziness Symptoms Inventory, and reduced avoidance and safety behaviors as measured by the Safety Behaviours Inventory. Pre- to posteffect sizes ranged from 0.98 to 1.15. There was no change in psychologic outcomes measured on the Depression, Anxiety and Stress Scales. CONCLUSIONS A 3-session psychologic intervention based on the CBT model can produce significant improvements in dizziness-related symptoms, disability, and functional impairment among patients with chronic subjective dizziness. This suggests that treatment of this condition may be reasonably simple and cost-effective for most of the patients.
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Interpersonal psychotherapy versus brief supportive therapy for depressed infertile women: first pilot randomized controlled trial. Arch Womens Ment Health 2012; 15:193-201. [PMID: 22526405 DOI: 10.1007/s00737-012-0277-z] [Citation(s) in RCA: 28] [Impact Index Per Article: 2.2] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/18/2011] [Accepted: 03/25/2012] [Indexed: 10/28/2022]
Abstract
Infertility is strongly associated with depression, yet treatment research for depressed infertile women is sparse. This study tested for the first time the feasibility and preliminary efficacy of interpersonal psychotherapy (IPT), the evidence-based antidepressant intervention with the greatest peripartum research support, as treatment for depressed women facing fertility problems. Patients who met DSM-IV criteria for major depressive disorder of at least moderate severity were randomized to either 12 sessions of IPT (n = 15) or brief supportive psychotherapy (BSP; n = 16), our control intervention. Eighty percent of IPT and 63 % of BSP patients completed the 12 sessions of therapy. Patients in both treatments improved. IPT produced a greater response rate than BSP, with more than two-thirds of women achieving a >50 % reduction in scores on the Montgomery-Åsberg Depression Rating Scale (MADRS). IPT also tended to have lower posttreatment scores on the Beck Depression Inventory, Clinical Global Impression-Severity Scale, and anxiety subscale of the Hamilton Depression Rating Scale, with between-group effect sizes ranging from 0.61 to 0.76. Gains persisted at 6-month follow-up. This pilot trial suggests that IPT is a promising treatment for depression in the context of infertility and that it may fare better than a rigorous active control condition. Should subsequent randomized controlled trials support these findings, this will inform clinical practice and take an important step in assuring optimal care for depressed women struggling with infertility.
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Nordgren LB, Andersson G, Kadowaki Å, Carlbring P. Tailored internet-administered treatment of anxiety disorders for primary care patients: study protocol for a randomised controlled trial. Trials 2012; 13:16. [PMID: 22321916 PMCID: PMC3305469 DOI: 10.1186/1745-6215-13-16] [Citation(s) in RCA: 9] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/22/2011] [Accepted: 02/09/2012] [Indexed: 11/24/2022] Open
Abstract
Background Internet-administered cognitive behavioural therapy (ICBT) has been found to be effective for a range of anxiety disorders. However, most studies have focused on one specific primary diagnosis and co-morbidity has not been considered. In primary care settings, patients with anxiety often suffer from more than one psychiatric condition, making it difficult to disseminate ICBT for specific conditions. The aim of this study will be to investigate if ICBT tailored according to symptom profile can be a feasible treatment for primary care patients with anxiety disorders. It is a randomised controlled trial aimed to evaluate the treatment against an active control group. Methods Participants with anxiety disorders and co-morbid conditions (N = 128), will be recruited from a primary care population. The Clinical Outcome in Routine Evaluation (CORE-OM) will serve as the primary outcome measure. Secondary measures include self-reported depression, anxiety, quality of life and loss of production and the use of health care. All assessments will be collected via the Internet and measure points will be baseline, post treatment and 12 months post treatment. Discussion This trial will add to the body of knowledge on the effectiveness of ICBT for anxiety disorders in primary care. The trial will also add knowledge on the long term effects of ICBT when delivered for regular clinic patients Trial Registration ClinicalTrials.gov: NCT01390168
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Affiliation(s)
- Lise Bergman Nordgren
- Department of Behavioural Sciences and Learning, Linköping University, 581 83 Linköping, Sweden.
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Choi I, Zou J, Titov N, Dear BF, Li S, Johnston L, Andrews G, Hunt C. Culturally attuned Internet treatment for depression amongst Chinese Australians: a randomised controlled trial. J Affect Disord 2012; 136:459-68. [PMID: 22177742 DOI: 10.1016/j.jad.2011.11.003] [Citation(s) in RCA: 100] [Impact Index Per Article: 7.7] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/09/2011] [Revised: 11/07/2011] [Accepted: 11/07/2011] [Indexed: 01/28/2023]
Abstract
INTRODUCTION Although depression can be treated effectively with Cognitive Behaviour Therapy (CBT), only a small percentage of Chinese Australians access evidence-based treatment due to practical and cultural barriers. The present study examined the efficacy and acceptability of an Internet delivered CBT (iCBT) program to treat Chinese Australians with depression. METHODS The Chinese depression iCBT program (the Brighten Your Mood Program) is a culturally adapted version of the clinically efficacious Sadness iCBT Program. Fifty-five Chinese Australians with depression were randomly allocated to either an immediate treatment group or to a waitlist control group. Treatment consisted of an 8 week program with 6 CBT online educational lessons, homework assignments, additional resources presented in Chinese and English, and weekly telephone support with Mandarin/Cantonese-speaking support personnel. An intention-to-treat model was used for data analyses. RESULTS Seventeen of twenty-five (68%) treatment group participants completed all lessons within the timeframe. Compared to controls, treatment group participants reported significantly reduced symptoms of depression on the Chinese versions of the Beck Depression Inventory (CBDI) and Patient Health Questionnaire-9 item (CB-PHQ-9). The within- and between-group effect sizes (Cohen's d) were 1.41 and 0.93 on the CBDI, and 0.90 and 0.50 on the CB-PHQ-9, respectively. Participants rated the procedure as acceptable, and gains were sustained at three-month follow-up. LIMITATIONS The study included several subclinical participants and some measures that have not been previously validated with Chinese Australians. CONCLUSIONS Results provide preliminary support for the efficacy and acceptability of an iCBT program at reducing symptoms of depression in Chinese Australians.
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Affiliation(s)
- Isabella Choi
- School of Psychology, University of Sydney, Sydney, Australia
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Johnston L, Titov N, Andrews G, Spence J, Dear BF. A RCT of a transdiagnostic internet-delivered treatment for three anxiety disorders: examination of support roles and disorder-specific outcomes. PLoS One 2011; 6:e28079. [PMID: 22132216 PMCID: PMC3223218 DOI: 10.1371/journal.pone.0028079] [Citation(s) in RCA: 94] [Impact Index Per Article: 6.7] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/28/2011] [Accepted: 10/31/2011] [Indexed: 11/18/2022] Open
Abstract
BACKGROUND Anxiety disorders share common vulnerabilities and symptoms. Disorder-specific treatment is efficacious, but few access evidence-based care. Administering transdiagnostic cognitive-behavioral therapy via the internet (iCBT) may increase access to evidence-based treatment, with a recent randomized controlled trial (RCT) providing preliminary support for this approach. This study extends those findings and aims to answer three questions: Is a transdiagnostic iCBT program for anxiety disorders efficacious and acceptable? Does it result in change for specific disorders? Can good clinical outcomes be obtained when guidance is provided via a Coach rather than a Clinician? METHOD RCT (N = 131) comparing three groups: Clinician-supported (CL) vs. Coach-supported (CO) vs. waitlist control (Control). Individuals met DSM-IV criteria for a principal diagnosis of generalized anxiety disorder (GAD), social phobia (SP) or panic disorder with or without agoraphobia (Pan/Ag). Treatment consisted of an 8-lesson/10 week iCBT program with weekly contact from a Clinician or Coach, and follow-up at 3-months post-treatment. RESULTS Outcomes for the pooled treatment groups (CL+CO) were superior to the Control group on measures of anxiety, depression and disability, were associated with medium to large effect sizes (Cohen's d = .76-1.44) (response rate = 89-100%), and were maintained at follow-up. Significant reductions were found on disorder-specific outcomes for each of the target diagnoses, and were associated with large effect sizes. CO participants achieved similar outcomes to CL participants at post-treatment, yet had significantly lower symptom severity scores on general anxiety, panic-disorder, depression and disability at follow-up (d = .45-.46). Seventy-four percent of CO and 76% of CL participants completed the program. Less than 70 minutes of Clinician or Coach time was required per participant during the program. DISCUSSION This transdiagnostic iCBT course for anxiety appears to be efficacious, associated with significant change for three target disorders, and is efficacious when guided by either a Clinician or Coach. TRIAL REGISTRATION Australian New Zealand Clinical Trials Registry ACTRN12610000242022.
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Affiliation(s)
- Luke Johnston
- CRUfAD, School of Psychiatry, University of New South Wales at St Vincent's Hospital, Sydney, Australia.
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Titov N, Dear BF, Schwencke G, Andrews G, Johnston L, Craske MG, McEvoy P. Transdiagnostic internet treatment for anxiety and depression: A randomised controlled trial. Behav Res Ther 2011; 49:441-52. [DOI: 10.1016/j.brat.2011.03.007] [Citation(s) in RCA: 211] [Impact Index Per Article: 15.1] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/09/2010] [Revised: 03/15/2011] [Accepted: 03/28/2011] [Indexed: 11/30/2022]
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