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

Zainab Samaan, Kathryn Litke, Kathleen McCabe, Brittany Dennis, Jeff Whattam, Laura Garrick, Laura O'Neill, Terri Ann Tabak, Scott Simons, Sandra Chalmers, Brenda Key, Meredith Vanstone, Feng Xie, Gordon Guyatt, Lehana Thabane, Zainab Samaan, Kathryn Litke, Kathleen McCabe, Brittany Dennis, Jeff Whattam, Laura Garrick, Laura O'Neill, Terri Ann Tabak, Scott Simons, Sandra Chalmers, Brenda Key, Meredith Vanstone, Feng Xie, Gordon Guyatt, Lehana Thabane

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/design: 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.

Discussion: The pilot study will help to inform a larger trial and assist in modifying the intervention based on patients' feedback.

Trial registration: Clinicaltrials.gov Identifier NCT02045771. Hamilton Integrated Research Ethics Board (HiREB) number: 14-042.

Keywords: Activation; Adult; Behavioural; Depression; Group; Pilot; Pragmatic; Protocol; Randomized; Trial.

Figures

Fig. 1
Fig. 1
BRAVE pilot pragmatic trial design. The PrECIs tool shows the current pilot study design to be closer to a pragmatic than explanatory trial (http://www.cmaj.ca/content/180/10/E47.full). The red line represents the score for each domain “spoke” of the proposed BRAVE trial
Fig. 2
Fig. 2
Pilot study components. a-eligibility and consent, b-baseline interview, diagnosis and demographics, c-physical measurements (height, weight, body fat percent), d-blood draw, e-Beck Depression Inventory (BDI II), f-Behavioural Activation for Depression Scale (BADS), g-Quality of life scales (SF-12, WSAS, and Q-LES-Q-SF), h-Leisure Motivation Scale (LMS), i-assumptions of risks, j-Physical Activity Readiness Questionnaire (PAR-Q), k- Activity tracking form, l- EQ-5D-5L a standardized instrument to measure health outcomes, m-qualitative individual interviews, n-focus group. S1-behavioural activation for depression, S2-values assessment, S3-goal setting, S4-Breaking it down, S5-avoidance and depression, S6- rumination, S7-ruminations II, S8-relationships, S9-involving others and social skills, S10-asseriveness and communication skills, S11-assetiveness and relaxation strategies, S12-leisure education, S13-problem solving, S14-team building and cooperative games, S15-nutrition and laughter yoga, S16- mindfullness and planning of group outing, S17-understanding sleep, S18-group outing, S19-getting back to work and volunteering, S20-S23 and S25-27 relapse prevention and troubleshooting, S24-booster group/adventure based day trip, S28-booster session and end of study. The qualitative components (l and m) are delivered in the pilot phase only. Adapted from Perera et al. [31]

References

    1. Wild B, Herzog W, Schellberg D, Lechner S, Niehoff D, Brenner H, Rothenbacher D, Stegmaier C, Raum E. Association between the prevalence of depression and age in a large representative German sample of people aged 53 to 80 years. Int J Geriatr Psychiatry. 2012;27(4):375–381.
    1. Martin-Merino E, Ruigomez A, Johansson S, Wallander MA, Garcia-Rodriguez LA. Study of a cohort of patients newly diagnosed with depression in general practice: prevalence, incidence, comorbidity, and treatment patterns. Prim Care Companion J Clin Psychiatry. 2010;12(1):PCC 08m00764.
    1. Wedegaertner F, Arnhold-Kerri S, Sittaro NA, Bleich S, Geyer S, Lee WE. Depression- and anxiety-related sick leave and the risk of permanent disability and mortality in the working population in Germany: a cohort study. BMC Public Health. 2013;13:145.
    1. Pigott HE, Leventhal AM, Alter GS, Boren JJ. Efficacy and effectiveness of antidepressants: current status of research. Psychother Psychosom. 2010;79(5):267–279.
    1. Sicras-Mainar A, Maurino J, Cordero L, Blanca-Tamayo M, Navarro-Artieda R. Assessment of pharmacological strategies for management of major depressive disorder and their costs after an inadequate response to first-line antidepressant treatment in primary care. Ann Gen Psychiatry. 2012;11(1):22.
    1. Colman I, Naicker K, Zeng Y, Ataullahjan A, Senthilselvan A, Patten SB. Predictors of long-term prognosis of depression. Can Med Assoc J. 2011;183(17):1969–1976.
    1. Huhn M, Tardy M, Spineli L, Kissling W, Förstl H, Pitschel-Walz G, et al. Efficacy of pharmacotherapy and psychotherapy for adult psychiatric disorders: a systematic overview of meta-analyses. JAMA Psychiatry. 2014;71(6):706–715.
    1. Sudak DM. Cognitive behavioral therapy for depression. Psychiatr Clin North Am. 2012;35(1):99–110.
    1. Martell CR, Dimidjian S, Herman‐Dunn R. Behavioral activation for depression: a clinician’s guide. Guilford: New York, NY; 2010.
    1. Lynch D, Laws KR, McKenna PJ. Cognitive behavioural therapy for major psychiatric disorder: does it really work? A meta-analytical review of well-controlled trials. Psychol Med. 2010;40(1):9–24.
    1. Høifødt RS, Strøm C, Kolstrup N, Eisemann M, Waterloo K. Effectiveness of cognitive behavioural therapy in primary health care: a review. Fam Pract. 2011;28(5):489–504.
    1. Mazzucchelli T, Kane R, Rees C. Behavioral activation treatments for depression in adults: a meta-analysis and review. Clin Psychol Sci Pract. 2009;16(4):383–411.
    1. Blenkiron P. Who is suitable for cognitive behavioural therapy? J R Soc Med. 1999;92(5):222–229.
    1. Morrison N. Group cognitive therapy: treatment of choice or sub-optimal option? Behav Cogn Psychother. 2001;29(03):311–332.
    1. Trivedi MH, Rush AJ, Wisniewski SR, Warden D, McKinney W, Downing M, Berman SR, Farabaugh A, Luther JF, Nierenberg AA, et al. Factors associated with health-related quality of life among outpatients with major depressive disorder: a STAR*D report. J Clin Psychiatry. 2006;67(2):185–195.
    1. Thabane L, Ma J, Chu R, Cheng J, Ismaila A, Rios LP, Robson R, Thabane M, Giangregorio L, Goldsmith CH. A tutorial on pilot studies: the what, why and how. BMC Med Res Methodol. 2010;10:1.
    1. Veale D. Behavioural activation for depression. Adv Psychiatr Treat. 2008;14:29–36.
    1. Kanter JW, Manos RC, Bowe WM, Baruch DE, Busch AM, Rusch LC. What is behavioral activation? A review of the empirical literature. Clin Psychol Rev. 2010;30(6):608–620.
    1. Jacobson NS, Dobson KS, Truax PA, Addis ME, Koerner K, Gollan JK, Gortner E, Prince SE. A component analysis of cognitive-behavioral treatment for depression. J Consult Clin Psychol. 1996;64(2):295–304.
    1. Kanter JW, Bush AM, Rusch LC. Behavioural activation: the CBT distinctive feature series. New York: Routledge; 2009.
    1. Cuijpers P, van Straten A, Warmerdam L. Behavioral activation treatments of depression: a meta-analysis. Clin Psychol Rev. 2007;27(3):318–326.
    1. Nierenberg AA, Ostacher MJ, Huffman JC, Ametrano RM, Fava M, Perlis RH. A brief review of antidepressant efficacy, effectiveness, indications, and usage for major depressive disorder. J Occup Environ Med. 2008;50(4):428–436.
    1. Mitchell J, Greenberg J, Finch K, Kovach J, Kipp L, Shainline M, Jordan N, Anderson C. Effectiveness and economic impact of antidepressant medications: a review. Am J Manag Care. 1997;3(2):323–330.
    1. Strauss DC, Thomas JM. What does the medical profession mean by “standard of care?”. J Clin Oncol. 2009;27(32):e192–193.
    1. Samaan Z, Dennis BB, Kalbfleisch L, Bami L, Zielinski L, Bawor M, et al. Behavioral activation for reducing depressive symptoms and improving quality of life: a feasibility study part one: a focus group study examining clinician and patient opinions on components of “Behavioural Activation Plus” Program. Under Review. 2015.
    1. Pfeiffer PN, Heisler M, Piette JD, Rogers MA, Valenstein M. Efficacy of peer support interventions for depression: a meta-analysis. Gen Hosp Psychiatry. 2011;33(1):29–36.
    1. 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;61(7):835–854.
    1. Patsopoulos NA. A pragmatic view on pragmatic trials. Dialogues Clin Neurosci. 2011;13(2):217–224.
    1. Zwarenstein M, Treweek S, Gagnier JJ, Altman DG, Tunis S, Haynes B, Oxman AD, Moher D. Improving the reporting of pragmatic trials: an extension of the CONSORT statement. BMJ. 2008;337:a2390.
    1. Thorpe KE, Zwarenstein M, Oxman AD, Treweek S, Furberg CD, Altman DG, Tunis S, Bergel E, Harvey I, Magid DJ, et al. A pragmatic-explanatory continuum indicator summary (PRECIS): a tool to help trial designers. CMAJ. 2009;180(10):E47–57.
    1. Perera R, Heneghan C, Yudkin P. Graphical method for depicting randomised trials of complex interventions. BMJ. 2007;334(7585):127–129.
    1. Wang YP, Gorenstein C. Psychometric properties of the Beck Depression Inventory-II: a comprehensive review. Rev Bras Psiquiatr. 2013;35(4):416–431.
    1. Krefetz DG, Steer RA, Gulab NA, Beck AT. Convergent validity of the Beck depression inventory-II with the reynolds adolescent depression scale in psychiatric inpatients. J Pers Assess. 2002;78(3):451–460.
    1. Edwards BC, Lambert MJ, Moran PW, McCully T, Smith KC, Ellingson AG. A meta-analytic comparison of the Beck Depression Inventory and the Hamilton Rating Scale for Depression as measures of treatment outcome. Br J Clin Psychol. 1984;23(Pt 2):93–99.
    1. Charmaz K. Constructing grounded theory: a practical guide through qualitative analysis. Pine Forge Press; 2006.
    1. Charmaz K. Constructionism and the grounded theory method. In: Holstein JA, Gubrium JF, editors. Handbook of constructionist research. edn. New York: Guilford Press; 2008. p. 822.
    1. Kitzinger J. Qualitative Research: Introducing focus groups BMJ 1995; 311:299.
    1. Sim J. Collecting and analysing qualitative data: issues raised by the focus group. J Adv Nurs. 1998;28(2):345–352.
    1. Poland B. Transcription quality as an aspect of rigor in qualitative research. Qual Inq. 1995;1(3):290–310.
    1. Charmaz K. Grounded theory: objectivist and constructivist methods. In: Denzin NK, Lincoln YS, editors. Handbook of qualitative research. Volume 2, edn. Thousand Oaks: Sage Publications; 2000. p. 1065.
    1. Boeije H. A purposeful approach to the constant comparative method in the analysis of qualitative interviews. Qual Quant. 2002;36(4):391–409.
    1. Corbin J, Strauss A. Basics of qualitative research: techniques and procedures for developing grounded theory. Sage; 2008.
    1. Chan AW, Tetzlaff JM, Gotzsche PC, Altman DG, Mann H, Berlin JA, Dickersin K, Hrobjartsson A, Schulz KF, Parulekar WR, et al. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013;346:e7586.

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