Overview

This trial is active, not recruiting.

Condition depression
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

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Other)
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.
support group
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.
(Experimental)
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 activation
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).

Primary Outcomes

Measure
Recruitment and retention rates, data completion, and resource utilization.
time frame: Baseline, Week 18

Secondary Outcomes

Measure
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

Eligibility Criteria

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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by St. Joseph's Healthcare Hamilton.