Contact information
Type
Scientific
Primary contact
Prof Graham Thornicroft
ORCID ID
Contact details
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
-
Graham.Thornicroft@iop.kcl.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
G0601660
Study information
Scientific title
CRIMSON Study: Randomised controlled trial (RCT) of Joint Crisis Plans to reduce compulsory treatment of people with psychosis
Acronym
CRIMSON
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
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
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Specified
Drug names
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 trial start date
01/04/2008
Overall trial end date
30/11/2011
Reason abandoned (if study stopped)
Eligibility
Participant 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.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
540 (180 per site)
Participant 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.
Recruitment start date
01/04/2008
Recruitment end date
30/11/2011
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Head of Health Service and Population Research Department
London
SE5 8AF
United Kingdom
Sponsor information
Organisation
King's College London (UK)
Sponsor details
c/o Dr Gill Lambert
Slam/IOP R&D Office
Institute of Psychiatry
De Crespigny Park
Denmark Hill
London
SE5 8AF
United Kingdom
-
Gill.Lambert@iop.kcl.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Research council
Funder name
Medical Research Council (UK)
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
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
4. 2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/29178895
Publication citations
-
Protocol
Thornicroft G, Farrelly S, Birchwood M, Marshall M, Szmukler G, Waheed W, Byford S, Dunn G, Henderson C, Lester H, Leese M, Rose D, Sutherby K, CRIMSON [CRisis plan IMpact: Subjective and Objective coercion and eNgagement] protocol: a randomised controlled trial of joint crisis plans to reduce compulsory treatment of people with psychosis., Trials, 2010, 11, 102, doi: 10.1186/1745-6215-11-102.
-
Results
Thornicroft G, Farrelly S, Szmukler G, Birchwood M, Waheed W, Flach C, Barrett B, Byford S, Henderson C, Sutherby K, Lester H, Rose D, Dunn G, Leese M, Marshall M, Clinical outcomes of Joint Crisis Plans to reduce compulsory treatment for people with psychosis: a randomised controlled trial., Lancet, 2013, 381, 9878, 1634-1641, doi: 10.1016/S0140-6736(13)60105-1.
-
Economic results
Barrett B, Waheed W, Farrelly S, Birchwood M, Dunn G, Flach C, Henderson C, Leese M, Lester H, Marshall M, Rose D, Sutherby K, Szmukler G, Thornicroft G, Byford S, Randomised controlled trial of joint crisis plans to reduce compulsory treatment for people with psychosis: economic outcomes., PLoS ONE, 2013, 8, 11, e74210, doi: 10.1371/journal.pone.0074210.