A randomised controlled trial of the clinical and cost-effectiveness of a contingency management intervention compared to treatment as usual 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.Z., Craig, M. and Hinton, M. 2016. A randomised controlled trial of the clinical and cost-effectiveness of a contingency management intervention compared to treatment as usual 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 compared to treatment as usual 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.Z., 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
PublisherBioMed Central
JournalTrials
ISSN
Electronic1745-6215
Publication dates
Online22 Oct 2016
Print31 Dec 2016
Publication process dates
Submitted28 Apr 2016
Accepted24 Sep 2016
Deposited29 Nov 2019
Output statusPublished
Publisher's version
License
File Access Level
Open
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
PubMed ID27770820
PubMed Central ID5075422
Web of Science identifierWOS:000385892000003
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Has versionhttp://europepmc.org/abstract/med/27770820
LanguageEnglish
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‘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.P. 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
Selecting outcome measures in mental health: the views of service users
Crawford, M.J., Robotham, D., Thana, L., Patterson, S., Weaver, T., Barber, R., Wykes, T. and Rose, D. 2011. Selecting outcome measures in mental health: the views of service users. Journal of Mental Health. 20 (4), pp. 336-346. https://doi.org/10.3109/09638237.2011.577114
Siblings of young people with Duchenne muscular dystrophy -- a qualitative study of impact and coping
Read, J., Kinali, M., Muntoni, F., Weaver, T. and Garralda, M.E. 2011. Siblings of young people with Duchenne muscular dystrophy -- a qualitative study of impact and coping. European Journal of Paediatric Neurology. 15 (1), pp. 21-28. https://doi.org/10.1016/j.ejpn.2010.07.006
Process, outcome and experience of transition from child to adult mental healthcare: multiperspective study
Singh, S.P., 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
Drug service user groups: only a partial solution to the problem of developing user involvement
Patterson, S., Weaver, T. and Crawford, M. 2010. Drug service user groups: only a partial solution to the problem of developing user involvement. Drugs: Education, Prevention, and Policy. 17 (1), pp. 84-97. https://doi.org/10.3109/09687630802225495
The prevalence of personality disorder, its comorbidity with mental state disorders, and its clinical significance in community mental health teams
Newton-Howes, G., Tyrer, P., Anagnostakis, K., Cooper, S., Bowden-Jones, O. and Weaver, T. 2010. The prevalence of personality disorder, its comorbidity with mental state disorders, and its clinical significance in community mental health teams. Social Psychiatry and Psychiatric Epidemiology. 45 (4), pp. 453-460. https://doi.org/10.1007/s00127-009-0084-7
A qualitative study of illicit and non-prescribed drug use amongst people with psychotic disorders
Charles, V. and Weaver, T. 2010. A qualitative study of illicit and non-prescribed drug use amongst people with psychotic disorders. Journal of Mental Health. 19 (1), pp. 99-106. https://doi.org/10.3109/09638230802523039
Child involvement in the paediatric consultation: a qualitative study of children and carers' views
Taylor, S., Haase-Casanovas, S., Weaver, T., Kidd, J. and Garralda, E.M. 2010. Child involvement in the paediatric consultation: a qualitative study of children and carers' views. Child: Care, Health and Development. 36 (5), pp. 678-685. https://doi.org/10.1111/j.1365-2214.2010.01076.x
Delusions and qualitative confusions: a dialogic collaborative exploration
Patterson, S., Hart, J. and Weaver, T. 2010. Delusions and qualitative confusions: a dialogic collaborative exploration. Qualitative Health Research. 20 (7), pp. 1008-1018. https://doi.org/10.1177/1049732310363805
Assessment of adverse effects in clinical studies of antipsychotic medication: survey of methods used
Pope, A., Adams, C., Paton, C., Weaver, T. and Barnes, T.R.E. 2010. Assessment of adverse effects in clinical studies of antipsychotic medication: survey of methods used. The British Journal of Psychiatry. 197 (1), pp. 67-72. https://doi.org/10.1192/bjp.bp.109.070961
User involvement in efforts to improve the quality of drug misuse services in England: a national survey
Patterson, S., Weaver, T., Agath, K., Rutter, D., Albert, E. and Crawford, M.J. 2009. User involvement in efforts to improve the quality of drug misuse services in England: a national survey. Drugs: Education, Prevention, and Policy. 16 (4), pp. 364-377. https://doi.org/10.1080/09687630802061544
Dedicated personality disorder services: a qualitative analysis of service structure and treatment process
Price, K., Gillespie, S., Rutter, D., Dhillon, K., Gibson, S., Faulkner, A., Weaver, T. and Crawford, M.J. 2009. Dedicated personality disorder services: a qualitative analysis of service structure and treatment process. Journal of Mental Health. 18 (6), pp. 467-475. https://doi.org/10.3109/09638230902968191
'They can't solve the problem without us': a qualitative study of stakeholder perspectives on user involvement in drug treatment services in England
Patterson, S., Weaver, T., Agath, K., Albert, E., Rhodes, T., Rutter, D. and Crawford, M. 2009. 'They can't solve the problem without us': a qualitative study of stakeholder perspectives on user involvement in drug treatment services in England. Health and Social Care in the Community. 17 (1), pp. 54-62. https://doi.org/10.1111/j.1365-2524.2008.00797.x
Use and perceived utility of structured violence risk assessments in English medium secure forensic units
Khiroya, R., Weaver, T. and Maden, A. 2009. Use and perceived utility of structured violence risk assessments in English medium secure forensic units. Psychiatric Bulletin. 33 (4), pp. 129-132. https://doi.org/10.1192/pb.bp.108.019810
Transitions of care from child and adolescent mental health services to adult mental health services (TRACK study): a study of protocols in Greater London
Singh, S.P., Paul, M., Ford, T., Kramer, T. and Weaver, T. 2008. Transitions of care from child and adolescent mental health services to adult mental health services (TRACK study): a study of protocols in Greater London. BMC Health Services Research. 8 (1), pp. 1-7. https://doi.org/10.1186/1472-6963-8-135
Attitudes of staff towards patients with personality disorder in community mental health teams
Newton-Howes, G., Weaver, T. and Tyrer, P. 2008. Attitudes of staff towards patients with personality disorder in community mental health teams. Australian & New Zealand Journal of Psychiatry. 42 (7), pp. 572-577. https://doi.org/10.1080/00048670802119739
Social functioning of patients with personality disorder in secondary care
Newton-Howes, G., Tyrer, P. and Weaver, T. 2008. Social functioning of patients with personality disorder in secondary care. Psychiatric Services. 59 (9), pp. 1033-1037. https://doi.org/10.1176/ps.2008.59.9.1033
Dedicated community-based services for adults with personality disorder: Delphi study
Crawford, M.J., Price, K., Rutter, D., Moran, P., Tyrer, P., Bateman, A., Fonagy, P. and Weaver, T. 2008. Dedicated community-based services for adults with personality disorder: Delphi study. The British Journal of Psychiatry. 193 (4), pp. 342-343. https://doi.org/10.1192/bjp.bp.107.043042
Role of qualitative research to inform design of epidemiological studies: a cohort study of mental health of migrants from the former Yugoslavia
Djuretic, T., Crawford, M.J. and Weaver, T. 2007. Role of qualitative research to inform design of epidemiological studies: a cohort study of mental health of migrants from the former Yugoslavia. Journal of Mental Health. 16 (6), pp. 743-755. https://doi.org/10.1080/09638230701496394
Prevalence of personality disorder in alcohol and drug services and associated comorbidity
Bowden-Jones, O., Iqbal, M., Tyrer, P., Seivewright, N., Cooper, S., Judd, A., Weaver, T. and the COSMIC study team 2004. Prevalence of personality disorder in alcohol and drug services and associated comorbidity. Addiction. 99 (10), pp. 1306-1314. https://doi.org/10.1111/j.1360-0443.2004.00813.x
User involvement in the planning and delivery of mental health services: a cross-sectional survey of service users and providers
Crawford, M.J., Aldridge, T., Bhui, K., Rutter, D., Manley, C., Weaver, T., Tyrer, P. and Fulop, N. 2003. User involvement in the planning and delivery of mental health services: a cross-sectional survey of service users and providers. Acta Psychiatrica Scandinavica. 107 (6), pp. 410-414. https://doi.org/10.1034/j.1600-0447.2003.00049.x
Assessing the value of assertive outreach: Qualitative study of process and outcome generation in the UK700 trial
Weaver, T., Tyrer, P., Ritchie, J. and Renton, A. 2003. Assessing the value of assertive outreach: Qualitative study of process and outcome generation in the UK700 trial. The British Journal of Psychiatry. 183 (5), pp. 437-435. https://doi.org/10.1192/bjp.183.5.437
Results of a screening survey for co-morbid substance misuse amongst patients in treatment for psychotic disorders: prevalence and service needs in an inner London borough
Weaver, T., Rutter, D., Madden, P., Ward, J., Stimson, G. and Renton, A. 2001. Results of a screening survey for co-morbid substance misuse amongst patients in treatment for psychotic disorders: prevalence and service needs in an inner London borough. Social Psychiatry and Psychiatric Epidemiology. 36 (8), pp. 399-406. https://doi.org/10.1007/s001270170030
The prevalence and management of co-morbid substance misuse and mental illness: results of a screening survey in substance misuse and mental health treatment populations
Weaver, T., Hickman, M., Rutter, D., Ward, J., Stimson, G. and Renton, A. 2001. The prevalence and management of co-morbid substance misuse and mental illness: results of a screening survey in substance misuse and mental health treatment populations. Drug and Alcohol Review. 20 (4), pp. 407-416. https://doi.org/10.1080/09595230120092724
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
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