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11 February 2012
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| [ Print-friendly version ] |
| Brixton Early Psychosis Project |
| ISRCTN | ISRCTN73679874 |
| ClinicalTrials.gov identifier | |
| Public title | Brixton Early Psychosis Project |
| Scientific title | |
| Acronym | N/A |
| Serial number at source | RDC01657 |
| Study hypothesis | The objective is to investigate whether patients randomly allocated to the Early Psychosis Service have better social and clinical outcomes than those managed by standard community teams. The primary outcomes are relapse, readmission and detention. Secondary outcomes of interest will include clinical and social functioning, user and carer satisfaction and burden. The research will also assess fidelity to the ACT model and describe team and services processes, training and any adaptations of the model needed to target early psychosis. |
| Lay summary | |
| Ethics approval | Not provided at time of registration |
| Study design | Randomised controlled trial |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Schizophrenia and other psychoses |
| Participants - inclusion criteria |
1. Aged 16 - 35 years
2. Living in the catchment areas served by the team (pop. approx 150,000) 3. Presenting with a first or second episode of a psychotic disorder (International Statistical Classification of Diseases and Related Health Problems, tenth edition [ICD-10] schizophrenia spectrum disorder including unspecified non-organic psychosis) Every effort will be made to include as many eligible patients as possible. For example, assistance of interpreters associated with the clinical service will be enlisted in order to include patients whose first language is not English.. |
| Participants - exclusion criteria | Patients with primary substance use disorder will not be eligible for the study. |
| Anticipated start date | 01/01/2000 |
| Anticipated end date | 01/07/2003 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 144 |
| Interventions |
1. Experimental group: will receive care from the Early Psychosis Service (a multi professional Assertive Community Treatment team targeted at people suffering their first or second episode of psychotic illness
2. Control group: will receive standard care as currently delivered though existing Sector Teams for the catchment areas |
| Primary outcome measure(s) | Relapse, readmission and detention at 18 months. We define relapse as any case noted record of a change in clinical state that has resulted in an increase in psychotrophic medication and/or an admission to hospital. |
| Secondary outcome measure(s) |
Secondary outcome measures will include a range of clinical social and service use outcomes:
1. Clinical measures at all three time points: 1.1. Brief psychiatric rating scale (BPRS) 1.2. Positive and negative syndrome scale (PANSS) 1.3. Global Assessment of Functioning (GAF) scale 1.4. Calgary Depression Scale 1.5. Insight Scale 1.6. Treatment compliance at 6 and 18 months 2. Social functioning at all three time points: 2.1. Employment status 2.2. Housing status 2.3. Benefit uptake 2.4. Social network scale 2.5. Life Skills Profile (LSP) 3. Patient and carer satisfaction/burden: 3.1. Verona satisfaction scale 3.2. Family burden at 18 months 4. Service use and costs: assessed retrospectively at 18 months based on a combination of service records and a standard instrument - the Client Service Receipt Inventory. Resource use will be identified for both treatment and control group and will include: 4.1. Medication costs 4.2. NHS services 4.3. Local authority services accommodation 4.4. Contact with criminal justice and all other services 4.5. Indirect economic impacts (particularly lost employment and caregiver burden) will also be included. 5. Team process measures and fidelity - team activity logs e.g.: 5.1. Contacts per client 5.2. Out of hours contacts 5.3. Interventions offered 5.4. Adherence to ACT model |
| Sources of funding | NHS Executive London (UK) |
| Trial website | |
| Publications |
1. 2004 results in http://www.ncbi.nlm.nih.gov/pubmed/15485934
2. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20435962 |
| Contact name | Prof Thomas Craig |
| Address |
Kings College London
4th Floor North Wing St Thomas Hospital Lambeth Palace Road |
| City/town | London |
| Zip/Postcode | SE1 7EH |
| Country | United Kingdom |
| Tel | +44 (0)20 7928 9292/3771 |
| t.craig@iop.kcl.ac.uk | |
| Sponsor | NHS R&D Regional Programme Register - Department of Health (UK) |
| Address |
The Department of Health
Richmond House 79 Whitehall |
| City/town | London |
| Zip/Postcode | SW1A 2NL |
| Country | United Kingdom |
| Tel | +44 (0)20 7307 2622 |
| Fax | +44 (0)20 7307 2623 |
| dhmail@doh.gsi.org.uk | |
| Sponsor website: | http://www.doh.gov.uk |
| Date applied | 23/01/2004 |
| Last edited | 04/05/2010 |
| Date ISRCTN assigned | 23/01/2004 |
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| © 2012 ISRCTN unless otherwise stated. | |
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