A Study to Assess the Effectiveness of Behavioural Activation Group Therapy in Individuals With Depression
A Study to Assess the Effectiveness of Behavioural Activation Group Therapy in Individuals With Depression
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.
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.
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