Clinical trial NCT02045771: A Pilot Study to Assess the Effectiveness of BehaviouRal ActiVation Group Program in Patients With dEpression: BRAVE
Official title: A Pragmatic Randomized Trial to Investigate the Effectiveness of BehaviouRal ActiVation Group Therapy in Reducing dEpressive Symptoms and Improving Quality of Life in Patients With Depression: BRAVE Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: Depression
Behavioral Activation
Lead sponsor: St. Joseph's Healthcare Hamilton
Sponsor class: OTHER
First posted: 2014-01-27
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study's primary goal is to assess the effectiveness of behavioural activation in reducing depressive symptoms and re-integrate patients with depression into their personal and professional lives thus improving quality of life and helping in attaining and maintaining remission of depression. It is aimed at helping patients re-engage with several life areas that they may have lost in the course of depressive illness. The intervention is centred on behavioural activation (BA) with complementary interventions including recreation activities, and behavioural modifications. The study question is: in patients with depressive disorder attending a specialized hospital based mood disorders clinic, does the addition of behavioural activation program delivered in a group format improve depressive symptoms and quality of life compared to treatment as usual after 18 weeks of treatment? Study investigators hypothesize that behavioural activation is an effective treatment for depressive disorder in patients with depression.

Detailed description: This is a pilot study, a mixed-methods design including an open label pragmatic randomized trial and a qualitative grounded theory approach. Participants will be randomized to Behavioural Activation (BA) (intervention) or support group (control) in addition to treatment as usual. The qualitative component will be used to gather participant's experiences, beliefs and opinions about two topics: 1) the experience of participating in the behavioural activation program and 2) their evolving perceptions of their individual depressive illness and quality of life. Based on the analysis of qualitative data pertaining to the first topic, the behavioural activation program may be modified for the main trial, to respond to patient needs and feedback, in the spirit of delivering truly patient centered care. The qualitative study will involve multiple interviews and focus groups which will take place before, during, and after the pilot intervention period.

Eligibility criteria: 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 Depressive Disorder

Primary outcomes:
measure: Recruitment and retention rates, data completion, and resource utilization.
timeFrame: Baseline, Week 18
Secondary outcomes:
measure: Qualitative study feedback.
timeFrame: At weeks 2 and 10 of the 18 week program.
measure: Feasibility of economic evaluation using the EuroQol economic evaluation tool; EQ-5D-5L.
timeFrame: Baseline, Week 18
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: St. Joseph's Healthcare Hamilton
state: Ontario
Study officials:
affiliation: McMaster University and St. Joseph's Healthcare Hamilton
name: Zainab Samaan, MBChB PhD MRCPsych
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Wampold BE, Minami T, Tierney SC, Baskin TW, Bhati KS. The placebo is powerful: estimating placebo effects in medicine and psychotherapy from randomized clinical trials. J Clin Psychol. 2005 Jul;61(7):835-54. doi: 10.1002/jclp.20129.
citation: D'Elia A, Bawor M, Dennis BB, Bhatt M, Litke K, McCabe K, Whattam J, Garrick L, O'Neill L, Simons S, Chalmers S, Key B, Goyert S, Laplante P, Vanstone M, Xie F, Guyatt G, Thabane L, Samaan Z. Feasibility of behavioral activation group therapy in reducing depressive symptoms and improving quality of life in patients with depression: the BRAVE pilot trial. Pilot Feasibility Stud. 2020 May 7;6:61. doi: 10.1186/s40814-020-00596-z. eCollection 2020.
citation: Chum J, Kim MS, Zielinski L, Bhatt M, Chung D, Yeung S, Litke K, McCabe K, Whattam J, Garrick L, O'Neill L, Goyert S, Merrifield C, Patel Y, Samaan Z. Acceptability of the Fitbit in behavioural activation therapy for depression: a qualitative study. Evid Based Ment Health. 2017 Nov;20(4):128-133. doi: 10.1136/eb-2017-102763. Epub 2017 Oct 22.
citation: Samaan Z, Dennis BB, Kalbfleisch L, Bami H, Zielinski L, Bawor M, Litke K, McCabe K, Whattam J, Garrick L, O'Neill L, Tabak TA, Simons S, Chalmers S, Key B, Vanstone M, Xie F, Guyatt G, Thabane L. Behavioral activation group therapy for reducing depressive symptoms and improving quality of life: a feasibility study. Pilot Feasibility Stud. 2016 Apr 29;2:22. doi: 10.1186/s40814-016-0064-0. eCollection 2016.
citation: Samaan Z, Litke K, McCabe K, Dennis B, Whattam J, Garrick L, O'Neill L, Tabak TA, Simons S, Chalmers S, Key B, Vanstone M, Xie F, Guyatt G, Thabane L. A pragmatic pilot randomized trial to investigate the effectiveness of behavioural activation group therapy in reducing depressive symptoms and improving quality of life in patients with depression: the BRAVE pilot trial protocol. Pilot Feasibility Stud. 2015 Nov 10;1:39. doi: 10.1186/s40814-015-0034-y. eCollection 2015.