Cluster randomised trial comparing outcomes of early psychosis care by a specialist team and augmented community mental health teams (CMHTs)

ISRCTN ISRCTN58681229
DOI https://doi.org/10.1186/ISRCTN58681229
Protocol serial number 03/38
Sponsor Camden and Islington Mental Health and Social Care Trust (UK)
Funder British Psychological Society
Submission date
02/08/2005
Registration date
11/11/2005
Last edited
19/09/2016
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
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Sonia Johnson
Scientific

Department of Mental Health Sciences
Riding House Street
London
W1W 7EY
United Kingdom

Email s.johnson@ucl.ac.uk

Study information

Primary study designInterventional
Study designRandomised controlled trial
Secondary study designRandomised controlled trial
Study type Participant information sheet
Scientific titleCluster randomised trial comparing outcomes of early psychosis care by a specialist team and augmented community mental health teams (CMHTs)
Study acronymSATS
Study objectivesThat the provision of services by specialist teams for people experiencing a first psychotic episode confers no advantage over the provision of services for first episode psychosis provided by augmented non-specialist teams
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedFirst episode psychosis
Intervention1. Specialist Early Intervention Service - a dedicated team specialising solely in the care of first episode psychosis. The team is multiprofessional and community based, has appropriate inpatient services and would be expected to maintain contact with all first episode patients for a period of 3 years.
2. Augmented community mental health teams. These community based multiprofessional teams provide general mental health services to defined geographical catchment areas. For the purpose of the trial the service will be augmented by two whole time equivalent staff who will focus solely on the care of first episode psychosis and will be expected to maintain contact with patients for a three year period.
Intervention typeOther
Primary outcome measure(s)

Proportion relapsing within 2 years of entry into the trial

Key secondary outcome measure(s)

1. Time to relapse
2. Whether engaged in paid employment or education for at least 15 hours per week
3. Quality of Life (MECCA)

Completion date31/01/2008

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
Upper age limit34 Years
SexAll
Target sample size at registration250
Key inclusion criteriaAll patients with a first psychotic episode aged between 18 and 34 referred to augmented and specialist services who are resident in the catchment area of the services
Key exclusion criteriaPeople will not be accepted for assessment if:
1. Their symptoms appear secondary to a primary diagnosis of emotionally unstable personality disorder or post-traumatic stress disorder
2. Their symptoms appear to be the clear result of drug induced psychosis, narrowly defined. Psychosis will only be viewed as drug induced if symptoms have emerged suddenly in the context of intoxication without any previous decline in functioning and if they subside within a few days
3. They have elevated mood but no psychotic symptoms
4. Their psychotic symptoms are not associated with any decline in functioning, disruption of development, distress or risk
5. They are thought to have taken antipsychotic medication for at least 6 weeks
6. They were first diagnosed as having a psychotic illness by a specialist mental health service more than 1 year ago
Date of first enrolment31/01/2005
Date of final enrolment31/01/2008

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

Department of Mental Health Sciences
London
W1W 7EY
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summary
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Participant information sheet Participant information sheet 11/11/2025 11/11/2025 No Yes

Editorial Notes

19/09/2016: No publications found, verifying study status with principal investigator.