Contact information
Type
Scientific
Primary contact
Prof Tom Burns
ORCID ID
Contact details
University Department of Psychiatry
Warneford Hospital
Oxford
OX3 7JX
United Kingdom
+44 (0)1865 226 474
tom.burns@psych.ox.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NIHR: RP-PG-0606-1006
Study information
Scientific title
A single centre randomised controlled trial of Community Treatment Order versus treatment on leave in patients with psychosis
Acronym
OCTET
Study hypothesis
The overall hypothesis is that the use of Community Treatment Orders (CTOs) in patients with psychosis and a history of compulsory admissions will result in a reduction in readmissions to hospital compared to treatment on leave. To test the hypothesis, the primary outcome measure is psychiatric hospitalisation in the 12-month follow-up period.
Ethics approval
North and South Staffordshire Research Ethics Committee awarded full ethical approval on 30th October 2008 (ref: 08/H1204/131)
Study design
Single centre randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Can be found at http://www.psychiatry.ox.ac.uk/research/researchunits/socpsych/research/octetinfo/participantinfo
Condition
Psychosis
Intervention
Eligible patients will be identified from current involuntary inpatients under the care of Community Mental Health Teams (CMHTs) and Assertive Outreach Teams (AOTs) who have agreed to collaborate. Teams must be able, and agree, to offer contact with the patient approximately weekly in either arm.
Access to patients is through a member of the care team. An independent researcher will assess and record the patient's capacity before seeking written informed consent. Participants will be interviewed at baseline and at 6 and 12 months, using appropriate validated and standardised questionnaires. Data related to the primary outcome measure (plus several secondary measures) will be collected from patients' medical records. After 12 months in the trial, care returns to normal.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Rate of readmission to hospital in a 12-month follow-up period
Secondary outcome measures
Measured at baseline, 6 and 12 months:
1. Number of days in psychiatric hospital
2. Time to readmissions
3. Engagement with clinical services and loss to care
4. Adherence to prescribed medication
5. Satisfaction with services
6. Clinical and social outcomes
Overall trial start date
03/11/2008
Overall trial end date
31/10/2010
Reason abandoned
Eligibility
Participant inclusion criteria
1. Aged 18 - 65 years (reflecting national service configurations), either sex
2. Diagnosed with psychosis
3. Currently admitted under a treatment section (section 3 or 37) of the Mental Health Act
4. Judged by their clinicians (psychiatrist and Approved Mental Health Professional) to need ongoing community treatment under compulsion
5. Able give written and informed consent
6. Not already participating in the study
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
300
Participant exclusion criteria
Subject to additional legal restrictions on treatment
Recruitment start date
03/11/2008
Recruitment end date
31/10/2010
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University Department of Psychiatry
Oxford
OX3 7JX
United Kingdom
Sponsor information
Organisation
Oxfordshire and Buckinghamshire Mental Health NHS Foundation Trust (UK)
Sponsor details
Littlemore Mental Health Centre
Sandford Road
Littlemore
Oxford
OX4 4XN
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
National Institute of Health Research (NIHR) (UK) - Programme Grant for Applied Research (PGfAR) (ref: RP-PG-0606-1006)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23537605
Publication citations
-
Results
Burns T, Rugkåsa J, Molodynski A, Dawson J, Yeeles K, Vazquez-Montes M, Voysey M, Sinclair J, Priebe S, Community treatment orders for patients with psychosis (OCTET): a randomised controlled trial., Lancet, 2013, 381, 9878, 1627-1633, doi: 10.1016/S0140-6736(13)60107-5.