Brixton Early Psychosis Project
| ISRCTN | ISRCTN73679874 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN73679874 |
| Protocol serial number | RDC01657 |
| Sponsor | NHS R&D Regional Programme Register - Department of Health (UK) |
| Funder | NHS Executive London (UK) |
- Submission date
- 23/01/2004
- Registration date
- 23/01/2004
- Last edited
- 04/05/2010
- 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 Thomas Craig
Scientific
Scientific
Kings College London
4th Floor
North Wing
St Thomas Hospital
Lambeth Palace Road
London
SE1 7EH
United Kingdom
| Phone | +44 (0)20 7928 9292/3771 |
|---|---|
| t.craig@iop.kcl.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | 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. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Schizophrenia and other psychoses |
| Intervention | 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 |
| Intervention type | Other |
| 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. |
| Key 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 |
| Completion date | 01/07/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 144 |
| Key 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.. |
| Key exclusion criteria | Patients with primary substance use disorder will not be eligible for the study. |
| Date of first enrolment | 01/01/2000 |
| Date of final enrolment | 01/07/2003 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Kings College London
London
SE1 7EH
United Kingdom
SE1 7EH
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 06/11/2004 | Yes | No | |
| Results article | results | 01/05/2010 | Yes | No |
