Plain English Summary
Background and study aims
Cannabis use increases the problems that people with severe mental health problems face. For example, young people with psychosis who use cannabis are more likely than those who do not to have difficulty recovering from their initial symptoms of psychosis, to relapse once they have recovered, to commit crimes, and less likely to work. Their need to rely on welfare benefits and frequent use of expensive services such as hospital has implications for society as a whole. Early intervention services (EISs) are a type of mental health team now available throughout England, They aim to improve prognosis for young people with early psychosis, reducing the likelihood that they will relapse and helping them achieve their goals, which may include getting back to work or education. Almost half the young people on EIS caseloads use cannabis, so that it is an important obstacle to recovery. Many young people who have developed a psychotic illness have some motivation for reducing their cannabis use. However, we do not have a really effective treatment available for helping them to do so. It has proved difficult to design treatments that work for drug use among people who have psychotic illnesses. Our aim is to try out a new approach called Contingency Management that is increasingly used in drug services but has not been studied a lot among people with psychosis.
Who can participate?
The participants in our study will be people aged between 18 and 39 who are currently under the care of an early intervention service for psychosis, and who have used cannabis in the past 6 months. They will be men and women.
What does the study involve?
The study will compare two approaches to helping people reduce their cannabis use. Group A will receive both a new approach called Contingency Management and a short educational package. Contingency Management involves receiving voucher rewards, to be spent in local shops, on condition of attending appointments and providing urine samples free from cannabis. Rewards increase with increasing weeks of abstinence over a 3 month period. The educational package is intended to help people to decide whether or not they wish to carry on using cannabis. Group B will receive the educational package only.
We will then compare Group A and Group B, assessing over an 18 month period which group is more likely to relapse, to use cannabis, to have more severe symptoms of psychosis, and to be in work or education.
What are the possible benefits and risks of participating?
The main benefit to participants will be if the study treatments, especially that received by Group A, turns out to help people to reduce their cannabis use. This may have significant benefits for their health and progress towards their goals in life. The participants in Group A will also benefit from receiving voucher rewards if they can avoid using cannabis. There are few significant risks: the vouchers will not be exchangeable for alcohol, but it is possible that some participants may find ways of informally trading them for money to purchase substances.
Where is the study run from?
The lead centre is the Mental Health Sciences Unit at University College London. There will be n initial study in three London Boroughs Camden, Islington and Hackney and in Coventry and Warwickshire NHS Foundation Trust, linked to the University of Warwick. If this goes well, we will add further teams to a full-scale study, based around UCL, the University of Warwick, the University of East Anglia and Kings College London.
When is the study starting and how long is it expected to run for?
We expect the study to start in January 2012. Over the first 18 months, we will carry out an initial study to test whether we can recruit participants and whether the study treatments are acceptable to patients and staff. If it goes well, more centres will be added to make it a full study. The total study period will be four and a half years, ending in July 2016.
Who is funding the study?
The study is funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme
Who is the main contact?
Prof. Sonia Johnson
s.johnson@ucl.ac.uk
Trial website
Contact information
Type
Scientific
Primary contact
Prof Sonia Johnson
ORCID ID
Contact details
Mental Health Sciences Unit
University College London
Charles Bell House
67-73 Riding House Street
London
W1W 7EY
United Kingdom
-
s.johnson@ucl.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
HTA 09/144/50
Study information
Scientific title
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
Acronym
CIRCLe
Study hypothesis
Time to relapse will be significantly greater in a group of early intervention service users who receive psychoeducation combined with contingency management (voucher rewards for evidence of abstinence) than in a group who receive the psychoeducation only.
More details can be found at: http://www.nets.nihr.ac.uk/projects/hta/0914450
Protocol can be found at: http://www.nets.nihr.ac.uk/__data/assets/pdf_file/0018/55170/PRO-09-144-50.pdf
Ethics approval
Not provided at time of registration
Study design
Feasibility pilot individually randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Quality of life
Patient information sheet
See additional files
Condition
Psychotic illnesses including schizophrenia, schizo-affective disorder and bipolar disorder with psychotic symptoms
Intervention
Experimental group: Contingency management involving voucher rewards for abstinence demonstrated by urinalysis together with psychoeducation delivered by care coordinators.
Control group: Psychoeducation only
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Time to relapse is assessed as admission to acute mental health care over 18 months
Secondary outcome measures
1. Presence of cannabis on urinalysis at 3 months and at 18 months of follow up
2. Positive symptom severity measured by Positive and Negative Syndrome Scale (PANSS) at 3 months and 18 months
3. Engagement in work or study is assessed by participant self report at 3 months and 18 months
Overall trial start date
01/09/2010
Overall trial end date
31/10/2017
Reason abandoned
Eligibility
Participant inclusion criteria
1. Under the care of an early intervention service for psychosis
2. Diagnostic criteria for EIS entry require a first psychotic episode significantly impairing functioning and lasting more than a week
3. Problematic cannabis use is operationalised as having used cannabis at least once in at least 12 of the previous 24 weeks
4. Aged 18-39, male and female participants
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
544 including 68 participants in feasibility pilot study
Participant exclusion criteria
Insufficient English to complete the study assessments
Recruitment start date
01/06/2012
Recruitment end date
31/03/2016
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University College London
London
W1W 7EY
United Kingdom
Sponsor information
Organisation
University College London (UK)
Sponsor details
c/o Dr Nick McNally
Director of Research Support
Joint University College London Hospitals/ University College London/ Royal Free Hospital Biomedical Research Unit
25 Grafton Way
London
WC1E 6DB
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
Health Technology Assessment Programme
Alternative name(s)
NIHR Health Technology Assessment Programme, HTA
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Planned publication of study results in a peer reviewed journal. Submission of a report to funders in November 2017.
IPD Sharing plan:
The current data sharing plans for the current study are unknown and will be made available at a later date.
Intention to publish date
01/05/2018
Participant level data
To be made available at a later date
Results - basic reporting
Publication summary
2016 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/27770820
Publication citations
Additional files
- ISRCTN33576045_PIS_12May14_V4.doc Uploaded 05/01/2017