Condition category
Mental and Behavioural Disorders
Date applied
11/12/2009
Date assigned
20/01/2010
Last edited
21/06/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.obmh.nhs.uk/

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

  1. 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.

Additional files

Editorial Notes