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Published in: Trials 1/2017

Open Access 01-12-2017 | Commentary

Benefits and challenges of using the cohort multiple randomised controlled trial design for testing an intervention for depression

Authors: Petter Viksveen, Clare Relton, Jon Nicholl

Published in: Trials | Issue 1/2017

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Abstract

Background

Trials which test the effectiveness of interventions compared with the status quo frequently encounter challenges. The cohort multiple randomised controlled trial (cmRCT) design is an innovative approach to the design and conduct of pragmatic trials which seeks to address some of these challenges.

Main text

In this article, we report our experiences with the first completed randomised controlled trial (RCT) using the cmRCT design. This trial—the Depression in South Yorkshire (DEPSY) trial—involved comparison of treatment as usual (TAU) with TAU plus the offer of an intervention for people with self-reported long-term moderate to severe depression. In the trial, we used an existing large population-based cohort: the Yorkshire Health Study. We discuss our experiences with recruitment, attrition, crossover, data analysis, generalisability of results, and cost. The main challenges in using the cmRCT design were the high crossover to the control group and the lower questionnaire response rate among patients who refused the offer of treatment. However, the design did help facilitate efficient and complete recruitment of the trial population as well as analysable data that were generalisable to the population of interest. Attrition rates were also smaller than those reported in other depression trials.

Conclusion

This first completed full trial using the cmRCT design testing an intervention for self-reported depression was associated with a number of important benefits. Further research is required to compare the acceptability and cost effectiveness of standard pragmatic RCT design with the cmRCT design.

Trial registration

ISRCTN registry: ISRCTN02484593. Registered on 7 Jan 2013.
Literature
1.
Relton C, Torgerson D, O’Cathain A, Nicholl J. Rethinking pragmatic RCTs: introducing the ‘cohort multiple RCT’ design. BMJ. 2010;340:c1066.CrossRefPubMed
2.
Flory JH, Mushlin AI, Goodman ZI. Proposals to conduct randomized controlled trials without informed consent: a narrative review. J Gen Intern Med. 2016;31:1511–8.CrossRefPubMed
3.
4.
Mitchell N, Hewitt C, Adamson J, Parrott S, Torgerson D, Ekers D, et al. A randomised evaluation of CollAborative care and active surveillance for Screen-Positive EldeRs with sub-threshold depression (CASPER): study protocol for a randomized controlled trials. Trials. 2011;12:225. doi:10.​1186/​1745-6215-12-225.CrossRefPubMedPubMedCentral
5.
Overend K, Lewis H, Bailey D, Bosanquet K, Chew-Graham C, Ekers D, et al. CASPER plus (CollAborative care in Screen-Positive EldeRs with major depressive disorder): study protocol for a randomised controlled trial. Trials. 2014;15:451. doi:10.​1186/​1745-6215-15-451.CrossRefPubMed
6.
7.
8.
Hughes-Morley A, Young B, Waheed W, Small N, Bower P. Factors affecting recruitment into depression trials: systematic review, meta-synthesis and conceptual framework. J Affect Disord. 2015;172:274–90.CrossRefPubMed
9.
Fairhurst K, Dowrick C. Problems with recruitment in a randomized controlled trial of counselling in general practice: causes and implications. J Health Serv Res Policy. 1996;1:77–80.PubMed
10.
Hetherton J, Matheson A, Robson M. Recruitment by GPs during consultations in a primary care randomized controlled trial comparing computerized psychological therapy with clinical psychology and routine GP care: problems and possible solutions. Prim Health Care Res Dev. 2004;5:5–10.CrossRef
11.
Woodford J, Farrand P, Bessant M, Williams C. Recruitment into a guided internet based CBT (iCBT) intervention for depression: lesson learnt from the failure of a prevalence recruitment strategy. Contemp Clin Trials. 2011;32:641–8.CrossRefPubMed
12.
Green MA, Li J, Relton C, Strong M, Kearns B, Wu M, et al. Cohort profile: the Yorkshire Health Study. Int J Epidemiol. 2016;45:707–12.CrossRefPubMed
13.
Viksveen P, Relton C. Depression treated by homeopaths: a study protocol for a pragmatic cohort multiple randomised controlled trial. Homeopathy. 2014;103:147–52.CrossRefPubMed
14.
Minas H, Klimidis S, Kokanovic R. Mental health research in general practice. Australas Psychiatry. 2005;13:181–4.CrossRefPubMed
15.
Heaven B, Murtagh M, Rapley T, May C, Graham R, Kaner E, et al. Patients or research subjects? A qualitative study of participation in a randomised controlled trial of a complex intervention. Patient Educ Couns. 2006;62:260–70.CrossRefPubMed
16.
17.
Torgerson DJ, Torgerson CJ. Designing randomised trials in health, education and the social sciences: an introduction. Basingstoke, UK: Palgrave Macmillan; 2008.CrossRef
18.
van der Velden JM, Verkooijen HM, Young-Afat DA, Burbach JPM, van Vulpen M, Relton C, et al. The cohort multiple randomized controlled trial design: a valid and efficient alternative to pragmatic trials? Int J Epidemiol. 2017;46:96–102. doi:10.​1093/​ije/​dyw050.PubMed
19.
20.
Spinelli MG, Endicott J, Goetz RR, Segre LS. Reanalysis of efficacy of interpersonal psychotherapy for antepartum depression versus parenting education program: initial severity of depression as a predictor of treatment outcome. J Clin Psychiatry. 2016;77:535–40. doi:10.​4088/​JCP.​15m09787.CrossRefPubMed
21.
22.
Walters SJ. Quality of life outcomes in clinical trials and health-care evaluation: a practical guide to analysis and interpretation. Chichester, UK: John Wiley & Sons; 2009.CrossRef
23.
Cook TD, Campbell DT. Quasi-experimentation: design & analysis issues for field settings. Chicago: Rand McNally; 1979.
24.
Becque T, White IR. Regaining power lost by non-compliance via full probability modelling. Stat Med. 2008;27:5640–63.CrossRefPubMed
25.
26.
Greenland S. An introduction to instrumental variables for epidemiologists. Int J Epidemiol. 2000;29:722–9.CrossRefPubMed
27.
Jefferis BJ, Nazareth I, Marston L, Moreno-Kustner B, Bellón JÁ, Svab I, et al. Associations between unemployment and major depressive disorder: evidence from an international, prospective study (the predict cohort). Soc Sci Med. 2011;73:1627–34.CrossRefPubMed
28.
Stafford M, Marmot M. Neighbourhood deprivation and health: does it affect us all equally? Int J Epidemiol. 2003;32:357–66.CrossRefPubMed
29.
Smith DJ, Nicholl BI, Cullen B, Martin D, Ul-Haq Z, Evans J, et al. Prevalence and characteristics of probable major depression and bipolar disorder within UK Biobank: cross-sectional study of 172,751 participants. PLoS One. 2014;8, e75362. doi:10.​1371/​journal.​pone.​0075362.CrossRef
30.
Kroenke K, Spitzer RL, Williams JBW, Löwe B. The Patient Health Questionnaire Somatic, Anxiety and Depressive Symptom Scales: a systematic review. Gen Hosp Psychiatry. 2010;32:345–59.CrossRefPubMed
31.
Cuijpers P, Li J, Hofmann SG, Andersson G. Self-reported versus clinician-rated symptoms of depression as outcome measures in psychotherapy research on depression: a meta-analysis. Clin Psychol Rev. 2010;30:768–78.CrossRefPubMed
Metadata
Title
Benefits and challenges of using the cohort multiple randomised controlled trial design for testing an intervention for depression
Authors
Petter Viksveen
Clare Relton
Jon Nicholl
Publication date
01-12-2017
Publisher
BioMed Central
Published in
Trials / Issue 1/2017
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-017-2059-4

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