title: 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: BACKGROUND
  Depression 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
  Using 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.
  
  
  CONCLUSIONS
  The pilot study will help to inform a larger trial and assist in modifying the intervention based on patients' feedback.
  
  
  BACKGROUND
  Clinicaltrials.gov Identifier NCT02045771. Hamilton Integrated Research Ethics Board (HiREB) number: 14-042.
authors.affiliation: Department of Psychiatry and Behavioural Neuroscience, McMaster University, Hamilton, ON Canada ; Mood Disorders Research Unit, St. Joseph's Healthcare Hamilton, Hamilton, ON Canada ; Department of Clinical Epidemiology & Biostatistics, McMaster University, Hamilton, ON Canada ; Population Genomics Program, Chanchlani Research Centre, McMaster University, Hamilton, ON Canada.
authors.forename: Zainab
authors.initials: Z
authors.lastname: Samaan
authors.affiliation: Mood Disorders Research Unit, St. Joseph's Healthcare Hamilton, Hamilton, ON Canada.
authors.forename: Kathryn
authors.initials: K
authors.lastname: Litke
authors.affiliation: Department of Psychiatry and Behavioural Neuroscience, McMaster University, Hamilton, ON Canada ; Mood Disorders Research Unit, St. Joseph's Healthcare Hamilton, Hamilton, ON Canada.
authors.forename: Kathleen
authors.initials: K
authors.lastname: McCabe
authors.affiliation: Department of Clinical Epidemiology & Biostatistics, McMaster University, Hamilton, ON Canada.
authors.forename: Brittany
authors.initials: B
authors.lastname: Dennis
authors.affiliation: Mood Disorders Research Unit, St. Joseph's Healthcare Hamilton, Hamilton, ON Canada.
authors.forename: Jeff
authors.initials: J
authors.lastname: Whattam
authors.affiliation: Mood Disorders Research Unit, St. Joseph's Healthcare Hamilton, Hamilton, ON Canada.
authors.forename: Laura
authors.initials: L
authors.lastname: Garrick
authors.affiliation: Department of Psychiatry and Behavioural Neuroscience, McMaster University, Hamilton, ON Canada ; Mood Disorders Research Unit, St. Joseph's Healthcare Hamilton, Hamilton, ON Canada.
authors.forename: Laura
authors.initials: L
authors.lastname: O'Neill
authors.affiliation: Department of Psychiatry and Behavioural Neuroscience, McMaster University, Hamilton, ON Canada ; Mood Disorders Research Unit, St. Joseph's Healthcare Hamilton, Hamilton, ON Canada.
authors.forename: Terri Ann
authors.initials: TA
authors.lastname: Tabak
authors.affiliation: Mood Disorders Research Unit, St. Joseph's Healthcare Hamilton, Hamilton, ON Canada.
authors.forename: Scott
authors.initials: S
authors.lastname: Simons
authors.affiliation: Mood Disorders Research Unit, St. Joseph's Healthcare Hamilton, Hamilton, ON Canada.
authors.forename: Sandra
authors.initials: S
authors.lastname: Chalmers
authors.affiliation: Department of Psychiatry and Behavioural Neuroscience, McMaster University, Hamilton, ON Canada ; Mood Disorders Research Unit, St. Joseph's Healthcare Hamilton, Hamilton, ON Canada.
authors.forename: Brenda
authors.initials: B
authors.lastname: Key
authors.affiliation: Department of Clinical Epidemiology & Biostatistics, McMaster University, Hamilton, ON Canada.
authors.forename: Meredith
authors.initials: M
authors.lastname: Vanstone
authors.affiliation: Department of Clinical Epidemiology & Biostatistics, McMaster University, Hamilton, ON Canada.
authors.forename: Feng
authors.initials: F
authors.lastname: Xie
authors.affiliation: Department of Clinical Epidemiology & Biostatistics, McMaster University, Hamilton, ON Canada ; Department of Medicine, McMaster University, Hamilton, ON Canada.
authors.forename: Gordon
authors.initials: G
authors.lastname: Guyatt
authors.affiliation: Department of Clinical Epidemiology & Biostatistics, McMaster University, Hamilton, ON Canada ; Centre for Evaluation of Medicine, Hamilton, ON Canada ; System-Linked Research Unit, Hamilton, ON Canada ; Department of Anaesthesia, McMaster University, Hamilton, ON Canada ; Department of Paediatrics, McMaster University, Hamilton, ON Canada.
authors.forename: Lehana
authors.initials: L
authors.lastname: Thabane
keywords: Activation; Adult; Behavioural; Depression; Group; Pilot; Pragmatic; Protocol; Randomized; Trial