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A Study to Assess the Effectiveness of Behavioural Activation Group Therapy in Individuals With Depression (BRAVE)

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ClinicalTrials.gov Identifier: NCT02297282
Recruitment Status : Recruiting
First Posted : November 21, 2014
Last Update Posted : May 7, 2018
Sponsor:
Information provided by (Responsible Party):
Zainab Samaan (Zena), St. Joseph's Healthcare Hamilton

Brief Summary:
Depression affects 15% of Canadians resulting in serious impact on health, ability to function including social, family and work related activities. Despite the several treatment options available for managing depression including medications, many patients do not respond to treatment and experience troublesome side effects. Psychotherapies are important in the treatment of depression and several options are currently being offered at the Mood Disorders Program (MDP), St. Joseph's Healthcare Hamilton. However a simple and reportedly effective therapy called Behavioural Activation (BA) is not currently available and existing evidence supporting its' effectiveness is limited to individual therapy of community based patients who are unlike the patients seen at the MDP who may have a more severe illness. The investigators are therefore planning to study the effectiveness of BA in patients with depression as an add on therapy to existing usual care compared to wait-list added to usual care. The study outcome is reduction in depressive symptoms and improvement in quality of life. The duration of therapy is 18 weeks and all adults with depression are eligible to participate.

Condition or disease Intervention/treatment Phase
Depression Behavioral: Behavioural Activation (BA) Not Applicable

Detailed Description:

This study is a pragmatic randomized controlled trial to test the effectiveness of behavioural activation in depression. The pragmatic randomized controlled trial study design is a parallel 1:1 allocation comparing behavioural activation plus treatment as usual to waitlist control group plus treatment as usual. For this study the investigators will adopt the following principals simulating naturalistic real life clinical setting to test the study question based on the pragmatic design:

  1. No restrictive inclusion criteria will be used. Adults with major depressive disorder will be asked to participate in this study
  2. Clinicians will deliver the BA program to participants randomized to receive the intervention
  3. The intervention will be an add-on to treatment as usual
  4. The comparison group will receive treatment as usual that may include medications, CBT and other therapies as required and decided by their clinical care
  5. The primary outcome is clinically relevant (improvement in depressive symptoms and quality of life)
  6. Both the intervention and control groups will be assessed as intention to treat analysis with no measures to improve adherence to the study intervention or the comparator.

Patients with a diagnosis of depressive disorders attending the mood disorders clinic, referred for assessment of depression at the clinic or referred from community or other hospital services to the mood disorders clinic will be approached for participation in the study. In addition family practices in the community will be informed of the study and asked to refer directly to the trial. Following initial screening for eligibility, potential participants will be asked to provide written informed consent prior to any study related procedures.

The investigators will employ a parallel group design to evaluate the effects of behavioural activation intervention to improve depression related outcomes. Eligible and consenting patients will be randomly allocated to the intervention or control arms using a 1:1 allocation ratio. Allocations will be generated using the computerized system. The randomization will use a block randomization system of block sizes of 2, 4 and 6. The assignment of participants to the intervention or control arms will be done after the screening visit and enrolment of at least 20 participants to ensure balanced groups. The allocation will be done by a research personnel who is not a clinician and will not know the participant clinical status to maintain allocation concealment.

This trial is an open label trial as blinding is not possible for participants (behavioural activation intervention) or the clinician administering the intervention.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 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 Patient With Depression: BRAVE Study.
Study Start Date : October 2014
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : October 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Behavioural 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. Behavioural Activation involves the use of activities to improve life situations or depressed mood.
Behavioral: Behavioural Activation (BA)
Behavioural activation is a therapy, which has been shown to be quite effective in the treatment of depression. 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.

No Intervention: Wait List (Control Group)
The Control group (waitlist) will receive treatment as usual while they are waiting to start the BA intervention at the end of the Intervention Group Therapy time (28 sessions over an 18 week period). In addition to usual care, the control group will be assessed by clinical staff that offers treatment as usual for mood symptoms and quality of life measures during the waiting time.



Primary Outcome Measures :
  1. Assess the effectiveness of a structured, therapist administered, face to face program of Behavioural Activation (BA) added to treatment as usual on depressive symptoms. [ Time Frame: end of the study period (18 weeks) ]
    The Beck Depression Inventory (BDI-II) is administered to measure the effectiveness of BA on depressive symptoms.


Secondary Outcome Measures :
  1. Test the effects of Behavioural Activation on changes in physical health parameters. [ Time Frame: at end of the study period (18 weeks) ]
    Quality of life

  2. Economic evaluation of the behavioural activation program in the study population. [ Time Frame: at the study end point (18 weeks). ]
    Economic evaluation of the BA program will be assessed using the EuroQol 5-Dimension (EQ-5D-5L), a commonly used standardized generic measure of health status and quality of life in a variety of clinical conditions.


Other Outcome Measures:
  1. A change in the mean weekly number of steps taken by participants. [ Time Frame: up to 18 weeks ]
    Study participants within the BA arm will be provided with "Fitbit" activity tracking monitors for use during the duration of the study.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (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 Major 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): NCT02297282


Contacts
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Contact: Laura Garrick, CCRA 905.522.1155 ext 35128 garrickl@stjoes.ca

Locations
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Canada, Ontario
St. Joseph's Healthcare Hamilton Recruiting
Hamilton, Ontario, Canada, L8N 3K7
Contact: Laura Garrick, CCRA    905.522.1155 ext 35409    lgarrick@stjoes.ca   
Principal Investigator: Zainab Samaan, MBChB, PHD, MRCPsych         
Sponsors and Collaborators
St. Joseph's Healthcare Hamilton
Investigators
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Principal Investigator: Zainab Samaan St. Joseph's Healthcare Hamilton

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Responsible Party: Zainab Samaan (Zena), Associate Professor and Psychiatrist, St. Joseph's Healthcare Hamilton
ClinicalTrials.gov Identifier: NCT02297282     History of Changes
Other Study ID Numbers: BRAVE_Main Study
First Posted: November 21, 2014    Key Record Dates
Last Update Posted: May 7, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Zainab Samaan (Zena), St. Joseph's Healthcare Hamilton:
Depression
Behavioural Activation
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders