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

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ClinicalTrials.gov Identifier: NCT02045771
Recruitment Status : Completed
First Posted : January 27, 2014
Last Update Posted : May 9, 2018
Sponsor:
Information provided by (Responsible Party):
Zainab Samaan (Zena), 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.

Condition or disease Intervention/treatment Phase
Depression Behavioral: Behavioral Activation Behavioral: Support Group Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : March 2014
Actual Primary Completion Date : April 24, 2017
Actual Study Completion Date : April 24, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Support Group (Control 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.
Behavioral: 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: Behavioral Activation
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
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 Outcome Measures :
  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 Outcome Measures :
  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".



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02045771


Locations
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Canada, Ontario
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada, L8N 3K7
Sponsors and Collaborators
St. Joseph's Healthcare Hamilton
Investigators
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Principal Investigator: Zainab Samaan, MBChB PhD MRCPsych McMaster University and St. Joseph's Healthcare Hamilton

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Zainab Samaan (Zena), Assistant Professor, St. Joseph's Healthcare Hamilton
ClinicalTrials.gov Identifier: NCT02045771     History of Changes
Other Study ID Numbers: BRAVE Pilot Trial
First Posted: January 27, 2014    Key Record Dates
Last Update Posted: May 9, 2018
Last Verified: January 2017
Keywords provided by Zainab Samaan (Zena), St. Joseph's Healthcare Hamilton:
Depression
Behavioral Activation
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders