A Pragmatic Randomized Trial to Investigate the Effectiveness of BehaviouRal ActiVation Group Therapy in Reducing dEpressive Symptoms and Improving Quality of Life in Patients With Depression: BRAVE Pilot Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Depression
- Sponsor
- St. Joseph's Healthcare Hamilton
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Recruitment and retention rates, data completion, and resource utilization.
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
The study's primary goal is to assess the effectiveness of behavioural activation in reducing depressive symptoms and re-integrate patients with depression into their personal and professional lives thus improving quality of life and helping in attaining and maintaining remission of depression. It is aimed at helping patients re-engage with several life areas that they may have lost in the course of depressive illness. The intervention is centred on behavioural activation (BA) with complementary interventions including recreation activities, and behavioural modifications. The study question is: in patients with depressive disorder attending a specialized hospital based mood disorders clinic, does the addition of behavioural activation program delivered in a group format improve depressive symptoms and quality of life compared to treatment as usual after 18 weeks of treatment? Study investigators hypothesize that behavioural activation is an effective treatment for depressive disorder in patients with depression.
Detailed Description
This is a pilot study, a mixed-methods design including an open label pragmatic randomized trial and a qualitative grounded theory approach. Participants will be randomized to Behavioural Activation (BA) (intervention) or support group (control) in addition to treatment as usual. The qualitative component will be used to gather participant's experiences, beliefs and opinions about two topics: 1) the experience of participating in the behavioural activation program and 2) their evolving perceptions of their individual depressive illness and quality of life. Based on the analysis of qualitative data pertaining to the first topic, the behavioural activation program may be modified for the main trial, to respond to patient needs and feedback, in the spirit of delivering truly patient centered care. The qualitative study will involve multiple interviews and focus groups which will take place before, during, and after the pilot intervention period.
Investigators
Zainab Samaan (Zena)
Assistant Professor
St. Joseph's Healthcare Hamilton
Eligibility Criteria
Inclusion Criteria
- •Clinical diagnosis of Major Depressive Disorder
- •Must be able to provide written informed consent
- •Must be able to attend program sessions
Exclusion Criteria
- •Inability to understand written and spoken English
- •Primary diagnosis other than Depressive Disorder
Outcomes
Primary Outcomes
Recruitment and retention rates, data completion, and resource utilization.
Time Frame: Baseline, Week 18
Assess feasibility of the study process in terms of recruitment, retention, number of sessions completed, average group size and data completion.
Secondary Outcomes
- Feasibility of economic evaluation using the EuroQol economic evaluation tool; EQ-5D-5L.(Baseline, Week 18)
- Qualitative study feedback.(At weeks 2 and 10 of the 18 week program.)