Feasibility of behavioral activation group therapy in reducing depressive symptoms and improving quality of life in patients with depression: the BRAVE pilot trial

Abstract Background Depression impacts the lives of millions of people worldwide. Behavioral activation (BA), derived from cognitive behavioral therapy, has the potential for improving depressive symptoms in patients with depression. Studies evaluating the effectiveness of BA specifically in the con...

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Main Authors: Alessia D’Elia, Monica Bawor, Brittany B. Dennis, Meha Bhatt, Kathryn Litke, Kathleen McCabe, Jeff Whattam, Laura Garrick, Laura O’Neill, Scott Simons, Sandra Chalmers, Brenda Key, Stefanie Goyert, Phillip Laplante, Meredith Vanstone, Feng Xie, Gordon Guyatt, Lehana Thabane, Zainab Samaan
Format: Article
Language:English
Published: BMC 2020-05-01
Series:Pilot and Feasibility Studies
Subjects:
Online Access:http://link.springer.com/article/10.1186/s40814-020-00596-z
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author Alessia D’Elia
Monica Bawor
Brittany B. Dennis
Meha Bhatt
Kathryn Litke
Kathleen McCabe
Jeff Whattam
Laura Garrick
Laura O’Neill
Scott Simons
Sandra Chalmers
Brenda Key
Stefanie Goyert
Phillip Laplante
Meredith Vanstone
Feng Xie
Gordon Guyatt
Lehana Thabane
Zainab Samaan
author_facet Alessia D’Elia
Monica Bawor
Brittany B. Dennis
Meha Bhatt
Kathryn Litke
Kathleen McCabe
Jeff Whattam
Laura Garrick
Laura O’Neill
Scott Simons
Sandra Chalmers
Brenda Key
Stefanie Goyert
Phillip Laplante
Meredith Vanstone
Feng Xie
Gordon Guyatt
Lehana Thabane
Zainab Samaan
author_sort Alessia D’Elia
collection DOAJ
description Abstract Background Depression impacts the lives of millions of people worldwide. Behavioral activation (BA), derived from cognitive behavioral therapy, has the potential for improving depressive symptoms in patients with depression. Studies evaluating the effectiveness of BA specifically in the context of group therapy programs in a hospital setting for patients with depression are limited. In this study, we report findings from a pilot trial evaluating group BA for major depressive disorder. Objective The objectives of this pilot trial are to assess the potential of a full trial of BA group therapy in a large-scale tertiary care setting and to provide preliminary information about possible results regarding mood symptoms and quality of life in adults with depression. Methods Using a parallel single-cohort pragmatic pilot randomized controlled trial design, we evaluated the potential of conducting a large trial of BA effectiveness among adults with depression. Participants were randomized to the intervention (BA in addition to usual care) or control (support group in addition to usual care) groups and were assessed weekly for 18 consecutive weeks. Participants randomized to intervention underwent 28 2-h group BA therapy visits administered by trained therapists and completed assessments to examine treatment outcomes. Feasibility was measured in terms of enrollment rates (min. 20%), completion rates of study (min. 80%), and completion rates of weekly measurement scales (min. 80%). The reporting of this pilot trial is in accordance with the CONSORT extension for randomized pilot and feasibility trials. Results We randomized 20 individuals of mean age of 48.8 years (standard deviation = 9.7) with a DSM-5 diagnosis of major depressive disorder to intervention (n = 10) or control (n = 10) groups. Based on our feasibility criteria, our recruitment rate was excellent (20/27; 74%), study completion was found to be a moderate (80% of the total participants in both arms completed the study; BA = 100%, control = 60%), and completeness of measurements on a weekly basis was adequate overall (82%; BA = 86%, control = 79%). Conclusions The study has demonstrated the potential feasibility to perform a larger scale trial upon modifications to the control group to avoid the low rate of study completion (60%) in this group. Trial registration ClinicalTrials NCT02045771 , Registered January 22, 2014
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spelling doaj.art-95e1b4b0d2834800aaeebaa572085e832022-12-22T01:54:02ZengBMCPilot and Feasibility Studies2055-57842020-05-016111110.1186/s40814-020-00596-zFeasibility of behavioral activation group therapy in reducing depressive symptoms and improving quality of life in patients with depression: the BRAVE pilot trialAlessia D’Elia0Monica Bawor1Brittany B. Dennis2Meha Bhatt3Kathryn Litke4Kathleen McCabe5Jeff Whattam6Laura Garrick7Laura O’Neill8Scott Simons9Sandra Chalmers10Brenda Key11Stefanie Goyert12Phillip Laplante13Meredith Vanstone14Feng Xie15Gordon Guyatt16Lehana Thabane17Zainab Samaan18Department of Psychiatry and Behavioural Neuroscience, McMaster UniversityDepartment of Psychiatry and Behavioural Neuroscience, McMaster UniversityPopulation Genomics Program, Chanchlani Research Centre, McMaster UniversityDepartment of Health Research, Evidence and Impact, McMaster UniversityPopulation Genomics Program, Chanchlani Research Centre, McMaster UniversityDepartment of Psychiatry and Behavioural Neuroscience, McMaster UniversityMood Disorders Program, St. Joseph’s Healthcare HamiltonMood Disorders Program, St. Joseph’s Healthcare HamiltonDepartment of Psychiatry and Behavioural Neuroscience, McMaster UniversityMood Disorders Program, St. Joseph’s Healthcare HamiltonMood Disorders Program, St. Joseph’s Healthcare HamiltonDepartment of Psychiatry and Behavioural Neuroscience, McMaster UniversityMood Disorders Program, St. Joseph’s Healthcare HamiltonDepartment of Psychiatry and Behavioural Neuroscience, McMaster UniversityDepartment of Health Research, Evidence and Impact, McMaster UniversityDepartment of Health Research, Evidence and Impact, McMaster UniversityDepartment of Health Research, Evidence and Impact, McMaster UniversityDepartment of Health Research, Evidence and Impact, McMaster UniversityDepartment of Psychiatry and Behavioural Neuroscience, McMaster UniversityAbstract Background Depression impacts the lives of millions of people worldwide. Behavioral activation (BA), derived from cognitive behavioral therapy, has the potential for improving depressive symptoms in patients with depression. Studies evaluating the effectiveness of BA specifically in the context of group therapy programs in a hospital setting for patients with depression are limited. In this study, we report findings from a pilot trial evaluating group BA for major depressive disorder. Objective The objectives of this pilot trial are to assess the potential of a full trial of BA group therapy in a large-scale tertiary care setting and to provide preliminary information about possible results regarding mood symptoms and quality of life in adults with depression. Methods Using a parallel single-cohort pragmatic pilot randomized controlled trial design, we evaluated the potential of conducting a large trial of BA effectiveness among adults with depression. Participants were randomized to the intervention (BA in addition to usual care) or control (support group in addition to usual care) groups and were assessed weekly for 18 consecutive weeks. Participants randomized to intervention underwent 28 2-h group BA therapy visits administered by trained therapists and completed assessments to examine treatment outcomes. Feasibility was measured in terms of enrollment rates (min. 20%), completion rates of study (min. 80%), and completion rates of weekly measurement scales (min. 80%). The reporting of this pilot trial is in accordance with the CONSORT extension for randomized pilot and feasibility trials. Results We randomized 20 individuals of mean age of 48.8 years (standard deviation = 9.7) with a DSM-5 diagnosis of major depressive disorder to intervention (n = 10) or control (n = 10) groups. Based on our feasibility criteria, our recruitment rate was excellent (20/27; 74%), study completion was found to be a moderate (80% of the total participants in both arms completed the study; BA = 100%, control = 60%), and completeness of measurements on a weekly basis was adequate overall (82%; BA = 86%, control = 79%). Conclusions The study has demonstrated the potential feasibility to perform a larger scale trial upon modifications to the control group to avoid the low rate of study completion (60%) in this group. Trial registration ClinicalTrials NCT02045771 , Registered January 22, 2014http://link.springer.com/article/10.1186/s40814-020-00596-zBehavioral activationBehavioral group therapyDepressionQuality of lifePilot randomized trial
spellingShingle Alessia D’Elia
Monica Bawor
Brittany B. Dennis
Meha Bhatt
Kathryn Litke
Kathleen McCabe
Jeff Whattam
Laura Garrick
Laura O’Neill
Scott Simons
Sandra Chalmers
Brenda Key
Stefanie Goyert
Phillip Laplante
Meredith Vanstone
Feng Xie
Gordon Guyatt
Lehana Thabane
Zainab Samaan
Feasibility of behavioral activation group therapy in reducing depressive symptoms and improving quality of life in patients with depression: the BRAVE pilot trial
Pilot and Feasibility Studies
Behavioral activation
Behavioral group therapy
Depression
Quality of life
Pilot randomized trial
title Feasibility of behavioral activation group therapy in reducing depressive symptoms and improving quality of life in patients with depression: the BRAVE pilot trial
title_full Feasibility of behavioral activation group therapy in reducing depressive symptoms and improving quality of life in patients with depression: the BRAVE pilot trial
title_fullStr Feasibility of behavioral activation group therapy in reducing depressive symptoms and improving quality of life in patients with depression: the BRAVE pilot trial
title_full_unstemmed Feasibility of behavioral activation group therapy in reducing depressive symptoms and improving quality of life in patients with depression: the BRAVE pilot trial
title_short Feasibility of behavioral activation group therapy in reducing depressive symptoms and improving quality of life in patients with depression: the BRAVE pilot trial
title_sort feasibility of behavioral activation group therapy in reducing depressive symptoms and improving quality of life in patients with depression the brave pilot trial
topic Behavioral activation
Behavioral group therapy
Depression
Quality of life
Pilot randomized trial
url http://link.springer.com/article/10.1186/s40814-020-00596-z
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