A Pilot Study to Assess the Effectiveness of BehaviouRal ActiVation Group Program in Patients With dEpression: BRAVE

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Depression

Intervention / Treatment
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* Behavioral: Behavioral Activation
* Behavioral: Support Group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Support Group (Control Group)<br>In addition to usual care, the control group will be offered a support group therapy format delivered at the same place, same visit frequency and duration of program as the intervention group. This support group is intended to simulate the intervention group format to minimize risk of biased estimate of BA effectiveness by reducing the potential placebo effect which can be seen due to frequent clinic visits and having additional attention beyond usual care. | Behavioral: Support Group<br>* In addition to usual care, the control group will be offered a support group therapy format delivered at the same place, same visit frequency and duration of program as the intervention group. This support group is intended to simulate the intervention group format to minimize risk of biased estimate of BA effectiveness by reducing the potential placebo effect which can be seen due to frequent clinic visits and having additional attention beyond usual care.<br>|
| Experimental: Behavioral Activation<br>Originally a component of cognitive therapy, behavioural activation is the use of strategies such as activity scheduling, master/pleasure ratings, and graded task assignments to change one's perception of specific situations. It involves the use of activities to improve life situations or depressed mood. | Behavioral: Behavioral Activation<br>* Behavioral activation is a therapy, which has been shown to be quite effective in the treatment of depression (Kanter, Manos et al. 2010; Martell, Dimidjian et al. 2010). Although previous therapies have focused more on the cognitive element, behavioural activation on its own has also been significantly effective for depression treatment (Jacobson, Dobson et al. 1996). The treatment works by increasing behaviours that help a patient with depression interact with an environment and providing consequences to positively reinforce antidepressant behaviour (Martell, Dimidjian et al. 2010).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recruitment and retention rates, data completion, and resource utilization. | Assess feasibility of the study process in terms of recruitment, retention, number of sessions completed, average group size and data completion. | Baseline, Week 18 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Qualitative study feedback. | The qualitative component of the pilot study is to assess the need to modify the protocol for the main trial based on participant's feedback. | At weeks 2 and 10 of the 18 week program. | 
| Feasibility of economic evaluation using the EuroQol economic evaluation tool; EQ-5D-5L. | EQ-5D-5L is a commonly used standardized generic measure of health and economic appraisal in a variety of clinical conditions. This will assist in the exploration of economic evaluation of the behavioral activation program in the main trial. the EQ-5D-5L consists of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The response to each dimension is a five-level severity ranging from no problem to extreme problem. | Baseline, Week 18 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Depression, Behavioral Activation