A pragmatic pilot randomized trial to investigate the effectiveness of behavioural activation group therapy in reducing depressive symptoms and improving quality of life in patients with depression: the BRAVE pilot trial protocol

Abstract

Background: Depression is a common disorder with a lifetime prevalence of 16 %. Despite the availability of several treatment options for depression, many patients do not respond to treatment and develop chronic illness associated with several secondary comorbidities. Behavioural activation (BA) is a simple therapy that has the potential for improving symptoms of depression and quality of life in patients with depression. The effectiveness of BA has not, however, been tested in a group format for patients with moderate to severe depression attending a specialized mood disorders tertiary care setting. Group format has the advantage of treating more patients at the same time especially in resource-limited settings. The primary objective of this pilot study is to test the feasibility of a main trial by assessing the recruitment and retention rates, average group size, completion of data and resources needed and receive the participants' feedback on the intervention. The secondary objective is to explore the change in mood and quality of life measures in adults with depression receiving BA.

Methods/design: Using a pragmatic pilot randomized controlled trial design, we will test the feasibility of a large trial to assess the effectiveness of BA added to usual care compared to a depression support group with usual care. Participants will be randomized after obtaining informed written consent to one of two study arms. Face-to-face group therapy will be provided in a hospital setting by trained therapists. Intervention and control groups will be seen twice weekly for 10 weeks and then once weekly for further 8 weeks. Participants will be completing mood symptom scales, quality of life questionnaires and anthropometric measures and provide blood samples for future analysis of biomarkers of response to treatment. During the pilot study we will also solicit participants' feedback and experience regarding the number, frequency and contents of the sessions as well as to explore participant perceptions of barriers or benefits associated with the BA program.

Discussion: The pilot study will help to inform a larger trial and assist in modifying the intervention based on patients' feedback.

Trial registration: Clinicaltrials.gov Identifier NCT02045771. Hamilton Integrated Research Ethics Board (HiREB) number: 14-042.

Keywords: Activation; Adult; Behavioural; Depression; Group; Pilot; Pragmatic; Protocol; Randomized; Trial.

Fig. 1

BRAVE pilot pragmatic trial design. The PrECIs tool shows the current pilot study design to be closer to a pragmatic than explanatory trial (http://www.cmaj.ca/content/180/10/E47.full). The red line represents the score for each domain “spoke” of the proposed BRAVE trial

Fig. 2

Pilot study components. a-eligibility and consent, b-baseline interview, diagnosis and demographics, c-physical measurements (height, weight, body fat percent), d-blood draw, e-Beck Depression Inventory (BDI II), f-Behavioural Activation for Depression Scale (BADS), g-Quality of life scales (SF-12, WSAS, and Q-LES-Q-SF), h-Leisure Motivation Scale (LMS), i-assumptions of risks, j-Physical Activity Readiness Questionnaire (PAR-Q), k- Activity tracking form, l- EQ-5D-5L a standardized instrument to measure health outcomes, m-qualitative individual interviews, n-focus group. S1-behavioural activation for depression, S2-values assessment, S3-goal setting, S4-Breaking it down, S5-avoidance and depression, S6- rumination, S7-ruminations II, S8-relationships, S9-involving others and social skills, S10-asseriveness and communication skills, S11-assetiveness and relaxation strategies, S12-leisure education, S13-problem solving, S14-team building and cooperative games, S15-nutrition and laughter yoga, S16- mindfullness and planning of group outing, S17-understanding sleep, S18-group outing, S19-getting back to work and volunteering, S20-S23 and S25-27 relapse prevention and troubleshooting, S24-booster group/adventure based day trip, S28-booster session and end of study. The qualitative components (l and m) are delivered in the pilot phase only. Adapted from Perera et al. [31]