Condition category
Mental and Behavioural Disorders
Date applied
15/02/2008
Date assigned
13/03/2008
Last edited
29/11/2013
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

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

Not specified

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 measures

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

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

http://www.kcl.ac.uk

Funders

Funder type

Research council

Funder name

Medical Research Council (UK)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

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

Results - basic reporting

Publication summary

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

Publication citations

  1. 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.

  2. 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.

  3. 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.

Additional files

Editorial Notes