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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 : Active, not recruiting
First Posted : November 21, 2014
Last Update Posted : September 23, 2019
Sponsor:
Information provided by (Responsible Party):
Zainab Samaan (Zena), St. Joseph's Healthcare Hamilton

Tracking Information
First Submitted Date  ICMJE September 5, 2014
First Posted Date  ICMJE November 21, 2014
Last Update Posted Date September 23, 2019
Study Start Date  ICMJE October 2014
Actual Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 20, 2014)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02297282 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 20, 2014)
  • 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
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: November 20, 2014)
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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE A Study to Assess the Effectiveness of Behavioural Activation Group Therapy in Individuals With Depression
Official Title  ICMJE 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.
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Depression
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Behavioural Activation (BA)
  • 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: September 19, 2019)
164
Original Estimated Enrollment  ICMJE
 (submitted: November 20, 2014)
160
Estimated Study Completion Date  ICMJE December 2019
Actual Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02297282
Other Study ID Numbers  ICMJE BRAVE_Main Study
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Zainab Samaan (Zena), St. Joseph's Healthcare Hamilton
Study Sponsor  ICMJE St. Joseph's Healthcare Hamilton
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Zainab Samaan St. Joseph's Healthcare Hamilton
PRS Account St. Joseph's Healthcare Hamilton
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP