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
Secondary identifying numbers	03/38

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

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Treatment
Participant information sheet	Not available in web format, please use contact details to request a participant information sheet
Scientific title	Cluster randomised trial comparing outcomes of early psychosis care by a specialist team and augmented community mental health teams (CMHTs)
Study acronym	SATS
Study objectives	That 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) studied	First episode psychosis
Intervention	1. 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 type	Other
Primary outcome measure	Proportion relapsing within 2 years of entry into the trial
Secondary outcome measures	1. Time to relapse 2. Whether engaged in paid employment or education for at least 15 hours per week 3. Quality of Life (MECCA)
Overall study start date	31/01/2005
Completion date	31/01/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	34 Years
Sex	Both
Target number of participants	250
Key inclusion criteria	All 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 criteria	People 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 enrolment	31/01/2005
Date of final enrolment	31/01/2008

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Department of Mental Health Sciences

London
W1W 7EY
United Kingdom

Sponsor information

Camden and Islington Mental Health and Social Care Trust (UK)
Hospital/treatment centre

St Pancras Hospital
4 St Pancras Way
London
NW1 0PE
England
United Kingdom

Phone	+44 (0)20 7530 3000
Email	candi@nhs.uk
Website	http://www.candi.nhs.uk
"ROR"	https://ror.org/03ekq2173

Funders

Funder type

Other

British Psychological Society
Private sector organisation / Associations and societies (private and public)

Alternative name(s): BPS
Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

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