A randomised controlled trial of the clinical and cost-effectiveness of a contingency management intervention for reduction of cannabis use and of relapse in early psychosis (CIRCLE): a study protocol for a randomised controlled trial

Article

Johnson, S., Rains, L., Marwaha, S., Strang, J., Craig, T., Weaver, T., McCrone, P., King, M., Fowler, D., Pilling, S., Marston, L., Omar, R., Craig, M. and Hinton, M. 2016. A randomised controlled trial of the clinical and cost-effectiveness of a contingency management intervention for reduction of cannabis use and of relapse in early psychosis (CIRCLE): a study protocol for a randomised controlled trial. Trials. 17 (1). https://doi.org/10.1186/s13063-016-1620-x
TypeArticle
TitleA randomised controlled trial of the clinical and cost-effectiveness of a contingency management intervention for reduction of cannabis use and of relapse in early psychosis (CIRCLE): a study protocol for a randomised controlled trial
AuthorsJohnson, S., Rains, L., Marwaha, S., Strang, J., Craig, T., Weaver, T., McCrone, P., King, M., Fowler, D., Pilling, S., Marston, L., Omar, R., Craig, M. and Hinton, M.
Abstract

Background:
Around 35–45 % of people in contact with services for a first episode of psychosis are using cannabis. Cannabis use is associated with delays in remission, poorer clinical outcomes, significant increases in the risk of relapse, and lower engagement in work or education. While there is a clear need for effective interventions, so far only very limited benefits have been achieved from psychological interventions. Contingency management (CM) is a behavioural intervention in which specified desired behavioural change is reinforced through financial rewards. CM is now recognised to have a substantial evidence base in some contexts and its adoption in the UK is advocated by the National Institute for Health and Care Excellence (NICE) guidance as a treatment for substance or alcohol misuse. However, there is currently little published data testing its effectiveness for reducing cannabis use in early psychosis.
Methods:
CIRCLE is a two-arm, rater-blinded randomised controlled trial (RCT) investigating the clinical and cost-effectiveness of a CM intervention for reducing cannabis use among young people receiving treatment from UK Early Intervention in Psychosis (EIP) services. EIP service users (n = 544) with a recent history of cannabis use will be recruited. The experimental group will receive 12 once-weekly CM sessions, and a voucher reward if urinalysis shows that they have not used cannabis in the previous week. Both the experimental and the control groups will be offered an Optimised Treatment as Usual (OTAU) psychoeducational package targeting cannabis use. Assessment interviews will be performed at consent, at 3 months, and at 18 months. The primary outcome is time to relapse, defined as admission to an acute mental health service. Secondary outcomes include proportion of cannabis-free urine samples during the intervention period, severity of positive psychotic symptoms, quality-adjusted life years, and engagement in work or education.
Discussion:
CIRCLE is a RCT of CM for cannabis use in young people with a recent history of psychosis (EIP service users) and recent cannabis use. It is designed to investigate whether the intervention is a clinically and cost-effective treatment for cannabis use. It is intended to inform future treatment delivery, particularly in EIP settings.

KeywordsFinancial incentives; Contingency management; Cannabis; Psychosis; Early intervention; Substance misuse
PublisherBMC
JournalTrials
ISSN
Electronic1745-6215
Publication dates
Online22 Oct 2016
Print31 Dec 2016
Publication process dates
Deposited29 Nov 2019
Accepted24 Sep 2016
Output statusPublished
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Copyright Statement

© The Author(s). 2016 Open Access
This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.
The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

Digital Object Identifier (DOI)https://doi.org/10.1186/s13063-016-1620-x
Web of Science identifierWOS:000385892000003
LanguageEnglish
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Völlm, B., Edworthy, R., Huband, N., Talbot, E., Majid, S., Holley, J., Furtado, V., Weaver, T., McDonald, R. and Duggan, C. 2018. Characteristics and pathways of long-stay patients in high and medium secure settings in England; a secondary publication from a large mixed-methods study. Frontiers in Psychiatry. 9. https://doi.org/10.3389/fpsyt.2018.00140
Randomised controlled trial of the clinical and cost-effectiveness of a peer-delivered self-management intervention to prevent relapse in crisis resolution team users: study protocol
Johnson, S., Mason, O., Osborn, D., Milton, A., Henderson, C., Marston, L., Ambler, G., Hunter, R., Pilling, S., Morant, N., Gray, R., Weaver, T., Nolan, F. and Lloyd-Evans, B. 2017. Randomised controlled trial of the clinical and cost-effectiveness of a peer-delivered self-management intervention to prevent relapse in crisis resolution team users: study protocol. BMJ Open. 7 (10). https://doi.org/10.1136/bmjopen-2016-015665
Feasibility trial of a psychoeducational intervention for parents with personality difficulties: The Helping Families Programme
Day, C., Briskman, J., Crawford, M., Harris, L., McCrone, P., McMurran, M., Moran, P., Morgan, L., Scott, S., Stahl, D., Ramchandani, P. and Weaver, T. 2017. Feasibility trial of a psychoeducational intervention for parents with personality difficulties: The Helping Families Programme. Contemporary Clinical Trials Communications. 8, pp. 67-74. https://doi.org/10.1016/j.conctc.2017.08.002
Improving GHB withdrawal with baclofen: study protocol for a feasibility study for a randomised controlled trial
Lingford-Hughes, A., Patel, Y., Bowden-Jones, O., Crawford, M., Dargan, P., Gordon, F., Parrott, S., Weaver, T. and Wood, D. 2016. Improving GHB withdrawal with baclofen: study protocol for a feasibility study for a randomised controlled trial. Trials. 17. https://doi.org/10.1186/s13063-016-1593-9
Mind how you cross the gap! Outcomes for young people who failed to make the transition from child to adult services: the TRACK study
Islam, Z., Ford, T., Kramer, T., Paul, M., Parsons, H., Harley, K., Weaver, T., McLaren, S. and Singh, S. 2016. Mind how you cross the gap! Outcomes for young people who failed to make the transition from child to adult services: the TRACK study. BJPsych Bulletin. 40 (3), pp. 142-148. https://doi.org/10.1192/pb.bp.115.050690
An economic evaluation of contingency management for completion of hepatitis B vaccination in those on treatment for opiate dependence
Rafia, R., Dodd, P., Brennan, A., Meier, P., Hope, V., Ncube, F., Byford, S., Tie, H., Metrebian, N., Hellier, J., Weaver, T. and Strang, J. 2016. An economic evaluation of contingency management for completion of hepatitis B vaccination in those on treatment for opiate dependence. Addiction. 111 (9), pp. 1616-1627. https://doi.org/10.1111/add.13385
Hearing voices simulation: Process and outcomes of training
Patterson, S., Goulter, N. and Weaver, T. 2014. Hearing voices simulation: Process and outcomes of training. Journal of Mental Health Training, Education and Practice. 9 (1), pp. 46-58. https://doi.org/10.1108/JMHTEP-01-2013-0003
Use of contingency management incentives to improve completion of hepatitis B vaccination in people undergoing treatment for heroin dependence: a cluster randomised trial
Weaver, T., Metrebian, N., Hellier, J., Pilling, S., Charles, V., Little, N., Poovendran, D., Mitcheson, L., Ryan, F., Bowden-Jones, O., Dunn, J., Glasper, A., Finch, E. and Strang, J. 2014. Use of contingency management incentives to improve completion of hepatitis B vaccination in people undergoing treatment for heroin dependence: a cluster randomised trial. The Lancet. 384 (9938), pp. 153-163. https://doi.org/10.1016/S0140-6736(14)60196-3
Activity and views of service users involved in mental health research: UK survey
Patterson, S., Trite, J. and Weaver, T. 2014. Activity and views of service users involved in mental health research: UK survey. The British Journal of Psychiatry. 205 (1), pp. 68-75. https://doi.org/10.1192/bjp.bp.113.128637
Influences on recruitment to randomised controlled trials in mental health settings in England: a national cross-sectional survey of researchers working for the Mental Health Research Network
Borschmann, R., Patterson, S., Poovendran, D., Wilson, D. and Weaver, T. 2014. Influences on recruitment to randomised controlled trials in mental health settings in England: a national cross-sectional survey of researchers working for the Mental Health Research Network. BMC Medical Research Methodology. 14 (1), p. 23. https://doi.org/10.1186/1471-2288-14-23
Monitoring and management of metabolic abnormalities: mixed-method evaluation of a successful intervention
Wilson, E., Randall, C., Patterson, S., Emmerson, B., Moudgil, V. and Weaver, T. 2014. Monitoring and management of metabolic abnormalities: mixed-method evaluation of a successful intervention. Australasian Psychiatry. 22 (3), pp. 248-253. https://doi.org/10.1177/1039856214529000
The effect of organisational resources and eligibility issues on transition from child and adolescent to adult mental health services
Belling, R., McLaren, S., Paul, M., Ford, T., Kramer, T., Weaver, T., Hovish, K., Islam, Z., White, S. and Singh, S. 2014. The effect of organisational resources and eligibility issues on transition from child and adolescent to adult mental health services. Journal of Health Services Research & Policy. 19 (3), pp. 169-176. https://doi.org/10.1177/1355819614527439
Multi-method Evaluation of the Management, Organisation and Staffing (MEMOS) in high security treatment services for people with Dangerous and Severe Personality Disorder (DSPD)
Trebilcock, J. and Weaver, T. 2010. Multi-method Evaluation of the Management, Organisation and Staffing (MEMOS) in high security treatment services for people with Dangerous and Severe Personality Disorder (DSPD). Personality Disorder Team.
Everybody knows that the prisoner is going nowhere: Parole Board members’ views about dangerous and severe personality disorder in England and Wales
Trebilcock, J. and Weaver, T. 2012. Everybody knows that the prisoner is going nowhere: Parole Board members’ views about dangerous and severe personality disorder in England and Wales. International Journal of Criminology and Sociology. 1, pp. 141-150. https://doi.org/10.6000/1929-4409.2012.01.14
‘Talking a different language’: an exploration of the influence of organizational cultures and working practices on transition from child to adult mental health services
McLaren, S., Belling, R., Paul, M., Ford, T., Kramer, T., Weaver, T., Hovish, K., Islam, Z., White, S. and Singh, S. 2013. ‘Talking a different language’: an exploration of the influence of organizational cultures and working practices on transition from child to adult mental health services. BMC Health Services Research. 13. https://doi.org/10.1186/1472-6963-13-254
The commissioning and provision of advocacy for problem drug users in English DATS; a cross sectional survey
Cargill, T., Weaver, T. and Patterson, S. 2012. The commissioning and provision of advocacy for problem drug users in English DATS; a cross sectional survey. Drugs: Education, Prevention, and Policy. 19 (2), pp. 163-170. https://doi.org/10.3109/09687637.2011.609204
Changing legal characteristics of dangerous and severe personality disorder (DSPD) patients and prisoners
Trebilcock, J. and Weaver, T. 2012. Changing legal characteristics of dangerous and severe personality disorder (DSPD) patients and prisoners. The Journal of Forensic Psychiatry & Psychology. 23 (2), pp. 237-243. https://doi.org/10.1080/14789949.2012.668212
‘It doesn't have to be treatable’: Mental Health Review Tribunal (MHRT) members’ views about Dangerous and Severe Personality Disorder (DSPD)
Trebilcock, J. and Weaver, T. 2012. ‘It doesn't have to be treatable’: Mental Health Review Tribunal (MHRT) members’ views about Dangerous and Severe Personality Disorder (DSPD). The Journal of Forensic Psychiatry & Psychology. 23 (2), pp. 244-260. https://doi.org/10.1080/14789949.2012.668208
Residents’ perceptions of water quality improvements following remediation work in the Pymme’s Brook catchment, north London, UK
Faulkner, H., Green, A., Pellaumail, K. and Weaver, T. 2001. Residents’ perceptions of water quality improvements following remediation work in the Pymme’s Brook catchment, north London, UK. Journal of Environmental Management. 62 (3), pp. 239-254. https://doi.org/10.1006/jema.2001.0435
Process, outcome and experience of transition from child to adult mental healthcare: multiperspective study
Singh, S., Paul, M., Ford, T., Kramer, T., Weaver, T., McLaren, S., Hovish, K., Islam, Z., Belling, R. and White, S. 2010. Process, outcome and experience of transition from child to adult mental healthcare: multiperspective study. The British Journal of Psychiatry. 197 (4), pp. 305-312. https://doi.org/10.1192/bjp.bp.109.075135
The Bentham unit: a pilot remand and assessment service for male mentally disordered remand prisoners. II: Report of an independent evaluation
Weaver, T., Taylor, F., Cunningham, B. and Maden, A. 1997. The Bentham unit: a pilot remand and assessment service for male mentally disordered remand prisoners. II: Report of an independent evaluation. The British Journal of Psychiatry. 170 (5), pp. 462-466. https://doi.org/10.1192/bjp.170.5.462