ISRCTN ISRCTN73679874
DOI https://doi.org/10.1186/ISRCTN73679874
Secondary identifying numbers RDC01657
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

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
Email t.craig@iop.kcl.ac.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Scientific title
Study objectivesThe 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) studiedSchizophrenia and other psychoses
Intervention1. 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 typeOther
Primary outcome measureRelapse, 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 measuresSecondary 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
Overall study start date01/01/2000
Completion date01/07/2003

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants144
Key inclusion criteria1. 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 criteriaPatients with primary substance use disorder will not be eligible for the study.
Date of first enrolment01/01/2000
Date of final enrolment01/07/2003

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Kings College London
London
SE1 7EH
United Kingdom

Sponsor information

NHS R&D Regional Programme Register - Department of Health (UK)
Government

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone +44 (0)20 7307 2622
Email dhmail@doh.gsi.org.uk
Website http://www.doh.gov.uk

Funders

Funder type

Government

NHS Executive London (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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