A Pilot Study to Assess the Effectiveness of BehaviouRal ActiVation Group

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02045771
Study type	Interventional
Source	St. Joseph's Healthcare Hamilton
Contact
Status	Completed
Phase	N/A
Start date	March 2014
Completion date	April 24, 2017

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms