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

Abstract

BackgroundDepression is a common disorder with a lifetime prevalence of 16 %. Despite the availability of several treatment options for depression, many patients do not respond to treatment and develop chronic illness associated with several secondary comorbidities. Behavioural activation (BA) is a simple therapy that has the potential for improving symptoms of depression and quality of life in patients with depression. The effectiveness of BA has not, however, been tested in a group format for patients with moderate to severe depression attending a specialized mood disorders tertiary care setting. Group format has the advantage of treating more patients at the same time especially in resource-limited settings. The primary objective of this pilot study is to test the feasibility of a main trial by assessing the recruitment and retention rates, average group size, completion of data and resources needed and receive the participants’ feedback on the intervention. The secondary objective is to explore the change in mood and quality of life measures in adults with depression receiving BA.Methods/DesignUsing a pragmatic pilot randomized controlled trial design, we will test the feasibility of a large trial to assess the effectiveness of BA added to usual care compared to a depression support group with usual care. Participants will be randomized after obtaining informed written consent to one of two study arms. Face-to-face group therapy will be provided in a hospital setting by trained therapists. Intervention and control groups will be seen twice weekly for 10 weeks and then once weekly for further 8 weeks. Participants will be completing mood symptom scales, quality of life questionnaires and anthropometric measures and provide blood samples for future analysis of biomarkers of response to treatment. During the pilot study we will also solicit participants’ feedback and experience regarding the number, frequency and contents of the sessions as well as to explore participant perceptions of barriers or benefits associated with the BA program.DiscussionThe pilot study will help to inform a larger trial and assist in modifying the intervention based on patients’ feedback.Trial registrationClinicaltrials.gov Identifier NCT02045771.Hamilton Integrated Research Ethics Board (HiREB) number: 14–042.

Feasibility of behavioral activation group therapy in reducing depressive symptoms and improving quality of life in patients with depression: the BRAVE pilot trial

“…This trial has been registered with ClinicalTrials.gov (identifier #NCT02045771) and was approved by the Hamilton Integrated Research Ethics Board (HIREB: 14-042). The protocol for this trial is published in Pilot and Feasibility Studies [20]. The reporting of this pilot trial is in accordance with the CONSORT extension for randomized pilot and feasibility trials [21,22].…”

“…A block randomization system with block sizes of 2, 4, and 6 randomly assigned allocations; the randomization schedule was computergenerated. Full details of the randomization assignment, concealment, and other trial-related methods are described in the protocol [20]. Ten participants were recruited to each arm of the study, which was decided based on the recommended therapy group size of 6-12 [20].…”

“…The detailed methods of BA administration are described elsewhere [20]. Briefly, the intervention consisted of 28 visits across 18 weeks: twice weekly until week 10 and once weekly thereafter.…”

Feasibility and implementation of a healthy lifestyles program in a community setting in Ontario, Canada: protocol for a pragmatic mixed methods pilot study

“…This study will combine multiple designs (pilot study, pragmatic trial, mixed methods study), as previously reported by Samaan et al 33. This will allow for the flexibility needed to study multiple dimensions of a new programme, especially one designed for creating healthy lifestyles through the development of participant-directed goals and individualised action plans 43–46.…”

“…This person-centred approach is not mainstream in the clinical setting and few individuals have access to behavioural therapists. Furthermore, many current available services and research studies address only one condition or patient population, exclude those who cannot participate in pre-set physical activity or exercise programmes, focus only on secondary or tertiary prevention, or neglect the role of mental health or the determinants of health in lifestyle changes 33–35. A new, multidisciplinary, person-centred, and evidence-based and practice-based healthy lifestyles programme has been created to address these needs 36.…”