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| CRIMSON Study: Randomised controlled trial (RCT) of Joint Crisis Plans to reduce compulsory treatment of people with psychosis |
| Source of record | UK Trials |
| ISRCTN | ISRCTN11501328 |
| Date ISRCTN assigned | 13/03/2008 |
| Local reference number(s) | G0601660 |
| Public title | CRIMSON Study: Randomised controlled trial (RCT) of Joint Crisis Plans to reduce compulsory treatment of people with psychosis |
| Scientific title | |
| Acronym | CRIMSON |
| Disease/condition/study domain | Psychosis |
| 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. |
| Design/methodology | An individual-level single-blind randomised controlled trial. |
| Research ethics review | This study has been reviewed and approved by King's College Hospital Research Ethics Committee (ref: 07/h0808/174) |
| Countries of trial | United Kingdom |
| 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. |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Anticipated start date | 01/04/2008 |
| Anticipated end date | 30/11/2011 |
| Status of trial | Ongoing |
| 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) |
| Sponsor name | 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 United Kingdom SE5 8AF |
| Sponsor email | Gill.Lambert@iop.kcl.ac.uk |
| Sponsor website | http://www.kcl.ac.uk |
| Contact name | Prof Graham Thornicroft |
| 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 United Kingdom SE5 8AF |
| Contact email | Graham.Thornicroft@iop.kcl.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN11501328 |
| Date last extracted from ISRCTN register | 17/04/2008 |
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