- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02297282
A Study to Assess the Effectiveness of Behavioural Activation Group Therapy in Individuals With Depression (BRAVE)
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 Overview
Status
Conditions
Intervention / Treatment
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:
- No restrictive inclusion criteria will be used. Adults with major depressive disorder will be asked to participate in this study
- Clinicians will deliver the BA program to participants randomized to receive the intervention
- The intervention will be an add-on to treatment as usual
- The comparison group will receive treatment as usual that may include medications, CBT and other therapies as required and decided by their clinical care
- The primary outcome is clinically relevant (improvement in depressive symptoms and quality of life)
- 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ontario
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Hamilton, Ontario, Canada, L8N 3K7
- St. Joseph's Healthcare Hamilton
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
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The Beck Depression Inventory (BDI-II) is administered to measure the effectiveness of BA on depressive symptoms.
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end of the study period (18 weeks)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Test the effects of Behavioural Activation on changes in physical health parameters.
Time Frame: at end of the study period (18 weeks)
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Quality of life
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at end of the study period (18 weeks)
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Economic evaluation of the behavioural activation program in the study population.
Time Frame: at the study end point (18 weeks).
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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.
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at the study end point (18 weeks).
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
A change in the mean weekly number of steps taken by participants.
Time Frame: up to 18 weeks
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Study participants within the BA arm will be provided with "Fitbit" activity tracking monitors for use during the duration of the study.
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up to 18 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Zainab Samaan, St. Joseph's Healthcare Hamilton
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BRAVE_Main Study
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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