ISRCTN ISRCTN73110773
DOI https://doi.org/10.1186/ISRCTN73110773
Secondary identifying numbers NIHR: RP-PG-0606-1006
Submission date
11/12/2009
Registration date
20/01/2010
Last edited
14/09/2015
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 Tom Burns
Scientific

University Department of Psychiatry
Warneford Hospital
Oxford
OX3 7JX
United Kingdom

Phone +44 (0)1865 226 474
Email tom.burns@psych.ox.ac.uk

Study information

Study designSingle-centre randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Can be found at http://www.psychiatry.ox.ac.uk/research/researchunits/socpsych/research/octetinfo/participantinfo
Scientific titleA single centre randomised controlled trial of Community Treatment Order versus treatment on leave in patients with psychosis
Study acronymOCTET
Study objectivesThe 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(s)North and South Staffordshire Research Ethics Committee, 30/10/2008, ref: 08/H1204/131
Health condition(s) or problem(s) studiedPsychosis
InterventionEligible 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 typeOther
Primary outcome measureRate of readmission to hospital in a 12-month follow-up period
Secondary outcome measuresMeasured 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 study start date03/11/2008
Completion date31/10/2010

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants300
Key inclusion criteria1. 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
Key exclusion criteriaSubject to additional legal restrictions on treatment
Date of first enrolment03/11/2008
Date of final enrolment31/10/2010

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Warneford Hospital
Oxford
OX3 7JX
United Kingdom

Sponsor information

Oxfordshire and Buckinghamshire Mental Health NHS Foundation Trust (UK)
Hospital/treatment centre

Littlemore Mental Health Centre
Sandford Road
Littlemore
Oxford
OX4 4XN
England
United Kingdom

Website http://www.obmh.nhs.uk/
ROR logo "ROR" https://ror.org/04c8bjx39

Funders

Funder type

Government

National Institute of Health Research (NIHR) (UK) - Programme Grant for Applied Research (PGfAR) (ref: RP-PG-0606-1006)

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 11/05/2013 Yes No
Results article results 01/10/2015 Yes No