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

Not Applicable

Completed

• Conditions: Depression

• Registration Number: NCT02045771
• Lead Sponsor: St. Joseph's Healthcare Hamilton

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.

Study Timeline

• Study First Submitted: 2014-01-22
• Study First Submitted QC: 2014-01-22
• Study First Posted: 2014-01-27
• Study Start: 2014-03
• Status Verified: 2017-01
• Primary Completion: 2017-04-24
• Study Completion: 2017-04-24
• Last Update Submitted: 2018-05-03
• Last Update Posted: 2018-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Recruitment and retention rates, data completion, and resource utilization.	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 Outcome Measures

Name	Time	Method
Feasibility of economic evaluation using the EuroQol economic evaluation tool; EQ-5D-5L.	Baseline, Week 18	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".
Qualitative study feedback.	At weeks 2 and 10 of the 18 week program.	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.

Trial Locations

Locations (1)

St. Joseph's Healthcare Hamilton; 🇨🇦 Hamilton, Ontario, Canada