Support Centre
30 October 2014 
ISRCTN Register - International Standard Randomized Controlled Trial Number
Trial registration
Unique identification scheme
International databases
home  |   my details  |   ISRCTN Register  |   mRCT  |   links  |   information  |   news
Find trials
ISRCTN Register
tips on searching

New application
Updating record

governing board
data set
letter of agreement
request information
guidance notes

[ Print-friendly version ]
CRIMSON Study: Randomised controlled trial (RCT) of Joint Crisis Plans to reduce compulsory treatment of people with psychosis
DOI 10.1186/ISRCTN11501328
ClinicalTrials.gov identifier
EudraCT number
Public title CRIMSON Study: Randomised controlled trial (RCT) of Joint Crisis Plans to reduce compulsory treatment of people with psychosis
Scientific title
Serial number at source G0601660
Study hypothesis The hypotheses to be tested are whether, compared with treatment as usual, Joint Crisis Plans improve: the proportion of service users treated under a section of the Mental Health Act, total costs, perceived coercion, service user engagement with mental health services, therapeutic alliance, and use of the Mental Health Act for the Black service users.

More details can be found at: http://www.mrc.ac.uk/ResearchPortfolio/Grant/Record.htm?GrantRef=G0601660&CaseId=9012
Lay summary Not provided at time of registration
Ethics approval This study has been reviewed and approved by King's College Hospital Research Ethics Committee (ref: 07/h0808/174)
Study design Individual-level single-blind randomised controlled trial
Countries of recruitment United Kingdom
Disease/condition/study domain Psychosis
Participants - inclusion criteria Eligible service users will have the following:
1. Contact with a local Community Mental Health Team (CMHT) (will include assertive outreach teams, early intervention teams, and community forensic teams, but not home treatment teams.)
2. Have been admitted to a psychiatric in-patient service at least once in the previous two years
3. Have a diagnosis of psychotic illness, including bipolar affective disorder (using Operational Criteria Checklist OPCRIT 47)
4. Be on the local NHS Trust Enhanced Care Programme Approach (CPA) Register

We shall include service users who do not speak English. For non-English speakers, both written translation and interpreters are needed. and we shall employ interpreters in French, Portuguese and some West African languages as required, and will be examined at the pilot stage.
Participants - exclusion criteria 1. Those unable to give informed consent
2. Current in-patients will not be recruited to avoid any perceived potential coercion to participate, nor any patient subject to a compulsory community treatment order

Note: No other exclusions will be made, to maximise the external validity of the trial.
Anticipated start date 01/04/2008
Anticipated end date 30/11/2011
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 540 (180 per site)
Interventions Service users under the care of community services in each of the participating inner-city sites (Birmingham, London and Manchester/Lancashire) will be identified by CPA and IT record systems and Care Co-ordinator case lists. Participants will be randomised to control or intervention. Those randomised to the intervention group will develop a Joint Crisis Plan. Those randomised to the control group, will continue to receive treatment as usual.

The Joint Crisis Plan (JCP) intervention aims to empower the holder and to facilitate early detection and treatment of relapse. It is developed by a mental health service user in collaboration with staff with the assistance of an independent facilitator. Held by the service user, it contains his or her treatment preferences for any future psychiatric emergency, when he or she may be too unwell to express clear views. The JCP format has developed over the last decade after widespread consultation with national service user groups, interviews with organisations and individuals using JCPs, and after detailed developmental work with service users in South London.
Primary outcome measure(s) Proportion of service users admitted or otherwise subsequently detained under an order of the Mental Health Act during the follow-up period (18 months)
Secondary outcome measure(s) 1. Cost
2. Perceived coercion, assessed at baseline and at follow-up (18 months post baseline) using the Treatment Experience Survey (questionnaire) delivered at interview
3. Engagement with mental health services, assessed at baseline and follow-up (18 months post baseline) using the Engagement and Acceptance Scale (questionnaire) delivered at interview
4. Therapeutic relationship for service users and staff, assessed at baseline and follow-up (18 months post baseline) using the Working Alliance Inventory (questionnaire) delivered at interview
Sources of funding Medical Research Council (UK)
Trial website
Publications 1. 2010 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/21054847
2. 2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23537606
3. 2013 economic results in: http://www.ncbi.nlm.nih.gov/pubmed/24282495
Contact name Prof  Graham  Thornicroft
  Address Head of Health Service and Population Research Department
PO 29 Section of Community Mental Health
King's College London
Institute of Psychiatry
De Crespigny Park
  City/town London
  Zip/Postcode SE5 8AF
  Country United Kingdom
  Email Graham.Thornicroft@iop.kcl.ac.uk
Sponsor King's College London (UK)
  Address c/o Dr Gill Lambert
Slam/IOP R&D Office
Institute of Psychiatry
De Crespigny Park
Denmark Hill
  City/town London
  Zip/Postcode SE5 8AF
  Country United Kingdom
  Email Gill.Lambert@iop.kcl.ac.uk
  Sponsor website: http://www.kcl.ac.uk
Date applied 15/02/2008
Last edited 29/11/2013
Date ISRCTN assigned 13/03/2008
Submit your trial protocol
Submit to Trials journal
Follow us on Twitter
© 2014 ISRCTN unless otherwise stated.