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

Alessia D'Elia¹, Monica Bawor^{1

2}, Brittany B Dennis^{2

3}, Meha Bhatt³, Kathryn Litke², Kathleen McCabe^{1

4}, Jeff Whattam⁴, Laura Garrick⁴, Laura O'Neill^{1

4}, Scott Simons⁴, Sandra Chalmers⁴, Brenda Key^{1

4}, Stefanie Goyert⁴, Phillip Laplante¹, Meredith Vanstone³, Feng Xie³, Gordon Guyatt^{3

5}, Lehana Thabane^{3

6

7

8

9}, Zainab Samaan^{1

2

3

4}

Affiliations

¹ 1Department of Psychiatry and Behavioural Neuroscience, McMaster University, 100 West 5th Street, Hamilton, ON Canada.
² 2Population Genomics Program, Chanchlani Research Centre, McMaster University, 1280 Main St. W, Hamilton, ON Canada.
³ 3Department of Health Research, Evidence and Impact, McMaster University, 1280 Main St. W, Hamilton, ON Canada.
⁴ 4Mood Disorders Program, St. Joseph's Healthcare Hamilton, 100 West 5th St, Hamilton, ON Canada.
⁵ 5Department of Medicine, McMaster University, 1280 Main St. W, Hamilton, ON Canada.
⁶ 6Biostatistics Unit, Centre for Evaluation of Medicine, Hamilton, ON Canada.
⁷ 7System-Linked Research Unit, McMaster University, 1280 Main St. W, Hamilton, ON Canada.
⁸ 8Department of Anesthesia, McMaster University, 1280 Main St. W, Hamilton, ON Canada.
⁹ 9Department of Pediatrics, McMaster University, 1280 Main St. W, Hamilton, ON Canada.

PMID: 32411381
PMCID: PMC7206724
DOI: 10.1186/s40814-020-00596-z

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

Alessia D'Elia et al. Pilot Feasibility Stud. 2020.

. 2020 May 7:6:61.

doi: 10.1186/s40814-020-00596-z. eCollection 2020.

Authors

Affiliations

¹ 1Department of Psychiatry and Behavioural Neuroscience, McMaster University, 100 West 5th Street, Hamilton, ON Canada.
² 2Population Genomics Program, Chanchlani Research Centre, McMaster University, 1280 Main St. W, Hamilton, ON Canada.
³ 3Department of Health Research, Evidence and Impact, McMaster University, 1280 Main St. W, Hamilton, ON Canada.
⁴ 4Mood Disorders Program, St. Joseph's Healthcare Hamilton, 100 West 5th St, Hamilton, ON Canada.
⁵ 5Department of Medicine, McMaster University, 1280 Main St. W, Hamilton, ON Canada.
⁶ 6Biostatistics Unit, Centre for Evaluation of Medicine, Hamilton, ON Canada.
⁷ 7System-Linked Research Unit, McMaster University, 1280 Main St. W, Hamilton, ON Canada.
⁸ 8Department of Anesthesia, McMaster University, 1280 Main St. W, Hamilton, ON Canada.
⁹ 9Department of Pediatrics, McMaster University, 1280 Main St. W, Hamilton, ON Canada.

PMID: 32411381
PMCID: PMC7206724
DOI: 10.1186/s40814-020-00596-z

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.

Keywords: Behavioral activation; Behavioral group therapy; Depression; Pilot randomized trial; Quality of life.

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Conflict of interest statement

Competing interestsThe authors declare that they have no competing interests.

Figures

**Fig. 1**
Flow diagram for participants included in the study

**Fig. 2**
Beck Depression Inventory (BDI) scores among participant groups over the study period (n = 20). Note: Control = blue; BA = green. For four participants missing the final BDI scores, the last observations were carried forward in this figure

See this image and copyright information in PMC

References

1. World Health Organization. Depression: fact sheet no. 369. 2018. Available: http://www.who.int/mediacentre/factsheets/fs369/en/. Accessed 22 Aug 2019.
1. Ferrari A, et al. Burden of depressive disorders by country, sex, age, and year: findings from the global burden of disease study 2010. PLoS Med. 2013;10(11):e1001547. doi: 10.1371/journal.pmed.1001547. - DOI - PMC - PubMed
1. Wulsin L, Vaillant G, Wells V. A systematic review of the mortality of depression. Psychosom Med. 1999;61(1):6–17. doi: 10.1097/00006842-199901000-00003. - DOI - PubMed
1. P. Cuijpers and F. Smit, “Excess mortality in depression: a meta-analysis of community studies,” J Affect Disord. 2002, doi: 10.1016/S0165-0327(01)00413-X. - PubMed
1. Fournier JC, et al. Antidepressant drug effects and depression severity: a patient-level meta-analysis. JAMA. 2010. 10.1001/jama.2009.1943. - PMC - PubMed

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

Affiliations

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

Authors

Affiliations

Abstract

Conflict of interest statement

Figures

References

Associated data

LinkOut - more resources

Full Text Sources

Medical