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

NCT02297282 | Completed

• 1 other identifier: BRAVE_Main Study
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression

Keywords

Depression; Behavioural Activation

Outcome Measures

Primary Outcomes (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.

  The Beck Depression Inventory (BDI-II) is administered to measure the effectiveness of BA on depressive symptoms.

  end of the study period (18 weeks)

Secondary Outcomes (2)

• Test the effects of Behavioural Activation on changes in physical health parameters.

  at end of the study period (18 weeks)

• Economic evaluation of the behavioural activation program in the study population.

  at the study end point (18 weeks).

Other Outcomes (1)

• A change in the mean weekly number of steps taken by participants.

  up to 18 weeks

Study Arms (2)

Behavioural Activation

EXPERIMENTAL

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)

Wait List (Control Group)

NO INTERVENTION

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.

Interventions

Behavioural Activation (BA) BEHAVIORAL

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.

Behavioural Activation

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Clinical diagnosis of Major Depressive Disorder
• Must be able to provide written informed consent
• Must be able to attend program sessions

You may not qualify if:

• Inability to understand written and spoken English
• Primary diagnosis other than Major Depressive Disorder

Sponsors & Collaborators

• St. Joseph's Healthcare Hamilton: lead

Study Sites (1)

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N 3K7, Canada

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Zainab Samaan

  St. Joseph's Healthcare Hamilton

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor and Psychiatrist

Study Record Dates

• First Submitted: September 5, 2014
• First Posted: November 21, 2014
• Study Start: October 1, 2014
• Primary Completion: September 1, 2019
• Study Completion: September 1, 2019
• Last Updated: February 21, 2020

Record last verified: 2020-02

Locations

CA (1)