Therapeutic community intervention trial

ISRCTN	ISRCTN57363317
DOI	https://doi.org/10.1186/ISRCTN57363317
Secondary identifying numbers	2.0

Submission date: 24/08/2009
Registration date: 18/02/2010
Last edited: 02/11/2022

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

Not provided at time of registration

Contact information

Dr Steve Pearce
Scientific

Oxfordshire Complex Needs Service
Manzil Way
Oxford
OX4 1XE
United Kingdom

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	Patient information can be found at http://www.psox.org/ocns/Information%20sheet.pdf
Scientific title	An exploratory randomised trial of day-therapeutic community treatment for people with personality disorder
Study acronym	TACIT
Study hypothesis	Among people with personality disorder, those randomised to referral for treatment from a day-based Democratic Therapeutic Community will have fewer days of psychiatric inpatient treatment at one year, compared to those receiving treatment as usual supplemented by the construction of a Crisis Plan.
Ethics approval(s)	Oxford Ethics Committee (REC B), 15/01/2009, ref: 08/H0605/87
Condition	Personality disorder
Intervention	Democratic Therapeutic Communities (DTC) is a form of psychosocial treatment based on a collaborative and deinstitutionalised approach to staff-patient interaction; particular emphasis is placed on personal responsibility, sharing and participation in communal activity. The four day Democratic Therapeutic Communities taking part in this study are all members of the Association of Therapeutic Communities and are all well established. They all offer day-patient and outreach services. The control condition will be delivered by members of a local Complex Needs team, and will consist of the construction of a crisis plan identifying triggers for deterioration in mental state, and practical steps that can be taken to get support or to maintain stability. This plan will be reviewed at 6, 12 and 24 months. Other elements of control treatment vary depending on patient needs and local service organisation but in all cases it includes outpatient monitoring, consideration of psychotropic medication and the option of referral to outpatient psychotherapy treatment and inpatient psychiatric treatment at times of crisis; these elements will be delivered by local general practitioners or Community Mental Health Teams.
Intervention type	Behavioural
Primary outcome measure	Number of days of inpatient psychiatric treatment in the year following randomisation.
Secondary outcome measures	1. Mental health - assessed using the General Health Questionnaire 2. Social Functioning - assessed using the Social Function Questionnaire 3. Extent of any aggressive behaviour towards others using the Modified Overt Aggression Scale 4. Satisfaction with care using the 8-item Client Satisfaction Questionnaire 5. Quality of life using Euro-Qol 6. Frequency of suicidal acts and acts of deliberate self harm collected via a self-report questionnaire developed specifically for the study 7. Direct costs (healthcare and non-health care) and productivity costs using a self-report questionnaire developed specifically for the study 8. Symptoms of personality disorder, and whether participants continue to fulfil criteria, will be assessed by repeat administration of the Structured Clinical Interview for DSM IV Axis II Personality Disorders.
Overall study start date	01/07/2009
Overall study end date	30/06/2013

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	85
Total final enrolment	70
Participant inclusion criteria	The study sample will be recruited from people in contact with primary care or mental health services and living in Oxfordshire. Day-Therapeutic Community services in this area are provided at four communities (in Oxford, Banbury, Wallingford and Witney). The study sample will be: 1. Resident in the community 2. Aged between 16 and 65 3. Have a diagnosis of personality disorder (assessed using the Structured Clinical Interview (II) for Axis 2 disorder)
Participant exclusion criteria	1. A primary diagnosis of a psychotic disorder, alcohol or drug dependence (those with a history of transient psychotic symptoms and non-dependent substance misuse will be included) 2. A degree of learning disability, or intellectual impairment which prevents engagement in Therapeutic Community services 3. Unwilling to provide written informed consent to participate in the trial
Recruitment start date	01/07/2009
Recruitment end date	30/06/2013

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Oxfordshire Complex Needs Service

Oxford
OX4 1XE
United Kingdom

Sponsor information

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

Trust Headquarters
4000 John Smith Drive
Oxford Business Park South
Oxford
OX4 2GX
England
United Kingdom

Phone	+44 (0)1865 741717
Email	Steve.Pearce@obmh.nhs.uk
"ROR"	https://ror.org/04c8bjx39

Funders

Funder type

Government

Oxfordshire and Buckinghamshire Mental Health NHS Foundation Trust (UK)

No information available

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	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		01/02/2017		Yes	No

Editorial Notes

02/11/2022: Total final enrolment added.
29/03/2018: Publication reference added.
03/02/2016: No publications found, verifying study status with principal investigator