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NCT Number: NCT02045771

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

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.

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Key information

Conditions

Depression Behavior Behavioral Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N 3K7, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Behavioral Activation

Behavioral

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).

Support group

Behavioral

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.

Primary outcomes

  1. Recruitment and retention rates, data completion, and resource utilization.

    Time frame: 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 outcomes

  1. Qualitative study feedback.

    Time frame: 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.

  2. Feasibility of economic evaluation using the EuroQol economic evaluation tool; EQ-5D-5L.

    Time frame: 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".

Sponsors and collaborators

Lead sponsor

St. Joseph's Healthcare Hamilton

Other

Registry information

Official study 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

Acronym: BRAVE

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Jan 27, 2014
Registry last updated
May 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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