|
ISRCTN
|
ISRCTN58681229
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
Cluster Randomised Trial comparing outcomes of early psychosis care by a specialist team and augmented community mental health teams (CMHTs)
|
|
Scientific title
|
|
|
Acronym
|
SATS
|
|
Serial number at source
|
03/38
|
|
Study hypothesis
|
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
|
|
Lay summary
|
|
|
Ethics approval
|
Not provided at time of registration
|
|
Study design
|
Randomised controlled trial
|
|
Countries of recruitment
|
United Kingdom
|
|
Disease/condition/study domain
|
First Episode Psychosis
|
|
Participants - 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
|
|
Participants - 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
|
|
Anticipated start date
|
31/01/2005
|
|
Anticipated end date
|
31/01/2008
|
|
Status of trial
|
Completed |
|
Patient information material
|
|
|
Target number of participants
|
250
|
|
Interventions
|
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.
|
|
Primary outcome measure(s)
|
Proportion relapsing within 2 years of entry into the trial
|
|
Secondary outcome measure(s)
|
1. Time to relapse
2. Whether engaged in paid employment or education for at leeast 15 hours per week
3. Quality of Life (MECCA)
|
|
Sources of funding
|
The British Psychological Society (UK) - Programme Grant
|
|
Trial website
|
|
|
Publications
|
|
|
Contact name
|
Dr
Sonia
Johnson
|
|
Address
|
Department of Mental Health Sciences
Riding House Street
|
|
City/town
|
London
|
|
Zip/Postcode
|
W1W 7EY
|
|
Country
|
United Kingdom
|
|
Email
|
s.johnson@ucl.ac.uk
|
|
Sponsor
|
Camden and Islington Mental Health and Social Care Trust (UK)
|
|
Address
|
St Pancras Hospital
4 St Pancras Way
|
|
City/town
|
London
|
|
Zip/Postcode
|
NW1 0PE
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 (0)20 7530 3000
|
|
Email
|
candi@nhs.uk
|
|
Sponsor website:
|
http://www.candi.nhs.uk
|
|
Date applied
|
02/08/2005
|
|
Last edited
|
15/07/2010
|
|
Date ISRCTN assigned
|
11/11/2005
|
