Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress 2023 EHA Congress 2023 ASCO Annual Meeting
Clinical Collections
Advances in Alzheimer’s

At a glance: The ONWARDS insulin icodec trials

A round-up of the ONWARDS phase 3 clinical trials evaluating the novel weekly insulin icodec in people with diabetes.
ADVANCED SEARCH
Log in
Top
Trials
Published in: Trials 1/2016

Open Access 01-12-2016 | Study protocol

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

Authors: Sonia Johnson, Luke Sheridan Rains, Steven Marwaha, John Strang, Thomas Craig, Tim Weaver, Paul McCrone, Michael King, David Fowler, Stephen Pilling, Louise Marston, Rumana Z. Omar, Meghan Craig, Mark Hinton

Published in: Trials | Issue 1/2016

Login to get access

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.

Trial registration

ISRCTN33576045: doi 10.​1186/​ISRCTN33576045, registered on 28 November 2011.
Literature
1.
Lambert M, Conus P, Lubman DI, Wade D, Yuen H, Moritz S, Naber D, McGorry PD, Schimmelmann BG. The impact of substance use disorders on clinical outcome in 643 patients with first-episode psychosis. Acta Psychiatr Scand. 2005;112:141–8.CrossRefPubMed
2.
Barnes TE, Mutsatsa SH, Hutton SB, Watt HC, Joyce EM. Comorbid substance use and age at onset of schizophrenia. Br J Psychiatry. 2006;188:237–42.CrossRefPubMed
3.
Linszen D, Dingemans P, Lenior M. Cannabis abuse and the course of recent-onset schizophrenic disorders. Arch Gen Psychiatry. 1994;51:273–4.CrossRefPubMed
4.
Verdoux H, Liraud F, Gonzales B, Assens F, Abalan F, Van Os J. Predictors and outcome characteristics associated with suicidal behaviour in early psychosis: a two-year follow-up of first-admitted subjects. Acta Psychiatr Scand. 2001;103:347–54.CrossRefPubMed
5.
Wade D, Harrigan S, Edwards J, Burgess PM, Whelan G, McGorry PD. Substance misuse in first-episode psychosis: 15-month prospective follow-up study. Br J Psychiatry. 2006;189:229–34.CrossRefPubMed
6.
Walsh E, Buchanan A, Fahy T. Violence and schizophrenia: examining the evidence. Br J Psychiatry. 2002;180:490–5.CrossRefPubMed
7.
Kooyman I, Dean K, Harvey S, Walsh E. Outcomes of public concern in schizophrenia. Br J Psychiatry. 2007;191:s29–36.CrossRef
8.
Marwaha S, Johnson S, Bebbington P, Stafford M, Angermeyer MC, Brugha T, Azorin J-M, Kilian R, Hansen K, Toumi M. Rates and correlates of employment in people with schizophrenia living in the UK, France and Germany: findings from the EuroSC study. Br J Psychiatry. 2007;191:30–7.CrossRefPubMed
9.
Jeffery D, Ley A, McLaren S, Siegfried N. Psychosocial treatment programmes for people with both severe mental illness and substance misuse. In: The Cochrane Library: Issue 3. Wiley: Chichester; 2004.
10.
11.
Barrowclough C, Haddock G, Tarrier N, Lewis SW, Moring J, O’Brien R, Schofield N, McGovern J. Randomized controlled trial of motivational interviewing, cognitive behavior therapy, and family intervention for patients with comorbid schizophrenia and substance use disorders. Am J Psychiatry. 2001;158:1706–13.CrossRefPubMed
12.
Addington J, Addington D. Patterns, predictors and impact of substance use in early psychosis: a longitudinal study. Acta Psychiatr Scand. 2007;115:304–9.CrossRefPubMed
13.
Archie S, Rush BR, Akhtar-Danesh N, Norman R, Malla A, Roy P, Zipurshy RB. Substance use and abuse in first-episode psychosis: prevalence before and after early intervention. Schizophr Bull. 2007;33(6):1354–63.CrossRefPubMedPubMedCentral
14.
Hides L, Dawe A, Kavanagh DJ, Young RM. Psychotic symptom and cannabis relapse in recent onset psychosis. Br J Psychiatry. 2006;189:137–43.CrossRefPubMed
15.
Mueser K, Drake R. Integrated dual disorder treatment in New Hampshire. In: Graham H, Copello A, Birchwood M, editors. Substance misuse in psychosis: approaches to treatment delivery. London: Wiley; 2003.
16.
Barrowclough C, Marshall M, Gregg L, Fitzsimmons M, Tomenson B, Warburton J, Lobban F. A phase-specific psychological therapy for people with problematic cannabis use following a first episode of psychosis: a randomized controlled trial. Psychol Med. 2014;44:2749–61.CrossRefPubMed
17.
18.
19.
National Institute for Health and Care Excellence (NICE). Clinical guideline on drug misuse in over 16 s: psychosocial interventions. Clinical Guideline 51. London: NICE; 2007.
20.
Secades-Villa R, García-Rodríguez O, Higgins S, Fernández-Hermida JR, Carballo JL. Community reinforcement approach plus vouchers for cocaine dependence in a community setting in Spain: six-month outcomes. J Subst Abuse Treat. 2008;34:202–7.CrossRefPubMed
21.
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, Strang J. Use of contingency management incentives to improve completion of hepatitis B vaccination in people undergoing treatment for heroin dependence: a cluster randomised trial. Lancet. 2014;384(9938):153–63.CrossRefPubMed
22.
Priebe S, Yeeles K, Bremner S, Lauber C, Eldridge S, Ashby D, David AS, O’Connell N, Forrest A, Burns T. Effectiveness of financial incentives to improve adherence to maintenance treatment with antipsychotics: cluster randomised controlled trial. BMJ. 2013;347:f5847.CrossRefPubMedPubMedCentral
23.
Bellack AS, Bennett ME, Gearon JS, Brown CH, Ye Yang MS. A randomized clinical trial of a new behavioral treatment for drug abuse in people with severe and persistent mental illness. Arch Gen Psychiatry. 2006;63:426–32.CrossRefPubMed
24.
Sigmon SC, Steingard S, Badger GJ, Anthony SL, Higgins ST. Contingent reinforcement of marijuana abstinence among individuals with serious mental illness: a feasibility study. Exp Clin Psychopharmacol. 2000;8:509–17.CrossRefPubMed
25.
Sigmon SC, Higgins ST. Voucher-based contingent reinforcement of marijuana abstinence among individuals with serious mental illness. J Subst Abuse Treat. 2006;30:291–5.CrossRefPubMed
26.
Edwards JE, Cocks J, Bott J. Preventative case management in first-episode psychosis. In: McGorry PD, Jackson HJ, editors. The recognition and management of early psychosis: a preventative approach. Cambridge: Cambridge University Press; 1999.
27.
Edwards J, Elkins K, Hinton M, Harrigan SM, Donovan K, Athanasopoulos O, McGorry PD. Randomized controlled trial of a cannabis-focused intervention for young people with first-episode psychosis. Acta Psychiatr Scand. 2006;114:109–17.CrossRefPubMed
28.
Budney A, Higgins S, Radonovich K, Novy PL. Adding voucher-based incentive to coping skills and motivational enhancement improves outcomes during treatment for marijuana dependence. J Consult Clin Psychol. 2000;68:1051–61.CrossRefPubMed
29.
Budney AJ, Moore BA, Rocha HL, Higgins ST. Clinical trial of abstinence-based vouchers and cognitive-behavioral therapy for cannabis dependence. J Consult Clin Psychol. 2006;74:307–16.CrossRefPubMed
30.
Sharma P, Murthy P, Bharath MMS. Chemistry, metabolism, and toxicology of cannabis: clinical implications. Iranian J Psychiatry. 2012;149–56.
31.
Department of Health. The NHS Plan: a plan for investment, a plan for reform. London: The Stationery Office; 2000.
32.
Robinson D, Woerner MG, Alvir JM, Bilder R, Goldman R, Geisler S, Koreen A, Sheitman B, Chakos M, Mayeroff D, Lieberman JA. Predictors of relapse following response from a first episode of schizophrenia or schizoaffective disorder. Arch Gen Psychiatry. 1999;56:241–6.CrossRefPubMed
33.
Gitlin MJ, Nuechterlein KH, Subotnik KL, Ventura J, Mintz J, Fogelson DL, Bartzokis G, Aravagiri M. Clinical outcome following neuroleptic discontinuation in remitted recent-onset schizophrenia patients. Am J Psychiatry. 2001;158:1835–42.CrossRefPubMed
34.
Sobell L, Sobell M. Timeline Follow-back. In: Allen J, Litten R, editors. Measuring alcohol consumption: psychosocial and biological methods. New Jersey: Humana Press; 1992.
35.
Robinson SM, Sobell LC, Sobell MB, Leo GI. Reliability of the Timeline Follow-back for cocaine, cannabis, and cigarette use. Psychol Addict Behav. 2014;28(1):154–62.CrossRefPubMed
36.
Kay S, Fiszbein R, Opler L. The positive and negative syndrome scale for schizophrenia. Schizophr Bull. 1987;13:261–76.CrossRefPubMed
37.
Leucht S, Kane JM, Kissling W, Hamann J, Etschel E, Engel RR. What does the PANSS mean? Schizophr Res. 2005;79:231–8.CrossRefPubMed
38.
Beecham J, Knapp M. Costing psychiatric interventions. In: Thornicroft G, editor. Measuring mental health needs. London: Gaskell; 2001.
39.
Brazier JE, Roberts JR. The estimation of a preference-based index from the SF-12. Med Care. 2004;42(9):851–9.CrossRefPubMed
40.
McCrone P, Patel A, Knapp M, Schene A, Koeter M, Ammadeo F, Ruggeri M, Giessler A, Puschner B, Thornicroft G. A comparison of SF-6D and EQ-5D utility scores in a study of patients with schizophrenia. J Ment Health Policy Econ. 2009;12(1):27–31.PubMed
41.
Rabin R, de Charro F. EQ-5D: a measure of health status from the EuroQol Group. Ann Med. 2001;33(5):337–43.CrossRefPubMed
42.
Salyers MP, Bosworth HB, Swanson JW, Lamb-Pagone J, Osher FC. Reliability and validity of the SF-12 health survey among people with severe mental illness. Med Care. 2000;38(11):1141–50.CrossRefPubMed
43.
Jenkinson C, Stewart-Brown S, Petersen S, Paice C. Assessment of the SF-36 version 2 in the United Kingdom. J Epidemiol Community Health. 1999;53:46–53.CrossRefPubMedPubMedCentral
44.
StataCorp. Stata Statistical Software: Release 11. College Station: StataCorp LP; 2009.
45.
Curtis L. Unit costs of health and social care. PSSRU: Canterbury; 2015.
46.
National Institute for Health and Care Excellence (NICE). Psychosis with substance misuse in over 14 s: assessment and management. In: Clinical Guideline 120. London: NICE; 2011.
47.
48.
Promberger M, Brown RC, Ashcroft RE, Marteau TM. Acceptability of financial incentives to improve health outcomes in UK and US samples. J Med Ethics. 2011;37:682–7.CrossRefPubMedPubMedCentral
Metadata
Title
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
Authors
Sonia Johnson
Luke Sheridan Rains
Steven Marwaha
John Strang
Thomas Craig
Tim Weaver
Paul McCrone
Michael King
David Fowler
Stephen Pilling
Louise Marston
Rumana Z. Omar
Meghan Craig
Mark Hinton
Publication date
01-12-2016
Publisher
BioMed Central
Published in
Trials / Issue 1/2016
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-016-1620-x

Other articles of this Issue 1/2016

Trials 1/2016 Go to the issue

Study protocol

BReastfeeding Attitude and Volume Optimization (BRAVO) trial: study protocol for a randomized controlled trial

Research

Randomized, controlled, two-arm, interventional, multicenter study on risk-adapted damage control orthopedic surgery of femur shaft fractures in multiple-trauma patients

Study protocol

Transcranial direct current stimulation in post-stroke sub-acute aphasia: study protocol for a randomized controlled trial

Study protocol

Comparing the effectiveness of the BPMAP (Blood Pressure Management Application) and usual care in self-management of primary hypertension and adherence to treatment in patients aged 30–60 years: study protocol for a randomized controlled trial

Research

From protocol to published report: a study of consistency in the reporting of academic drug trials

Study protocol

‘Walk This Way’ – a pilot of a health coaching intervention to reduce sedentary behaviour and increase low intensity exercise in people with serious mental illness: study protocol for a randomised controlled trial