A Study to Assess the Effectiveness of Behavioural Activation Group Therapy in Individuals With Depression
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional

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.
    

Intervention name(s): Behavioural Activation (BA)
Intervention type(s): Behavioral
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Depression; Behavioural Activation