CRIMSON Study: Randomised controlled trial (RCT) of Joint Crisis Plans to reduce compulsory treatment of people with psychosis

ISRCTN	ISRCTN11501328
DOI	https://doi.org/10.1186/ISRCTN11501328
Secondary identifying numbers	G0601660

Submission date: 15/02/2008
Registration date: 13/03/2008
Last edited: 28/11/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Graham Thornicroft
Scientific

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
London
SE5 8AF
United Kingdom

Email	Graham.Thornicroft@iop.kcl.ac.uk

Study information

Study design	Individual-level single-blind randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	CRIMSON Study: Randomised controlled trial (RCT) of Joint Crisis Plans to reduce compulsory treatment of people with psychosis
Study acronym	CRIMSON
Study objectives	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
Ethics approval(s)	This study has been reviewed and approved by King's College Hospital Research Ethics Committee (ref: 07/h0808/174)
Health condition(s) or problem(s) studied	Psychosis
Intervention	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.
Intervention type	Other
Primary outcome measure	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 measures	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
Overall study start date	01/04/2008
Completion date	30/11/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	540 (180 per site)
Key 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.
Key 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.
Date of first enrolment	01/04/2008
Date of final enrolment	30/11/2011

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Head of Health Service and Population Research Department

London
SE5 8AF
United Kingdom

Sponsor information

King's College London (UK)
University/education

c/o Dr Gill Lambert
Slam/IOP R&D Office
Institute of Psychiatry
De Crespigny Park
Denmark Hill
London
SE5 8AF
England
United Kingdom

Email	Gill.Lambert@iop.kcl.ac.uk
Website	http://www.kcl.ac.uk
"ROR"	https://ror.org/0220mzb33

Funders

Funder type

Research council

Medical Research Council (UK)
Government organisation / National government

Alternative name(s): Medical Research Council (United Kingdom), UK Medical Research Council, MRC
Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Peer reviewed?	Patient-facing?
Protocol article	protocol	05/11/2010	Yes	No
Results article	results	11/05/2013	Yes	No
Results article	economic results	25/11/2013	Yes	No
Results article	results	24/11/2017	Yes	No

Editorial Notes

28/11/2017: Publication reference added