A Pilot Study to Assess the Effectiveness of BehaviouRal ActiVation Group Program in Patients With dEpression: BRAVE
This trial is active, not recruiting.
|Treatments||behavioral activation, support group|
|Sponsor||St. Joseph's Healthcare Hamilton|
|Start date||March 2014|
|End date||June 2016|
|Trial size||24 participants|
|Trial identifier||NCT02045771, BRAVE Pilot Trial|
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.
|Intervention model||parallel assignment|
Recruitment and retention rates, data completion, and resource utilization.
time frame: Baseline, Week 18
Qualitative study feedback.
time frame: At weeks 2 and 10 of the 18 week program.
Feasibility of economic evaluation using the EuroQol economic evaluation tool; EQ-5D-5L.
time frame: Baseline, Week 18
Male or female participants at least 18 years old.
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
|Official title||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|
|Principal investigator||Zainab Samaan, MBChB PhD MRCPsych|
|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.|
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