Condition category
Mental and Behavioural Disorders
Date applied
24/08/2009
Date assigned
18/02/2010
Last edited
03/02/2016
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

Dr Steve Pearce

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

2.0

Study information

Scientific title

An exploratory randomised trial of day-therapeutic community treatment for people with personality disorder

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

Oxford Ethics Committee (REC B), 15/01/2009, ref: 08/H0605/87

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Patient information can be found at http://www.psox.org/ocns/Information%20sheet.pdf

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

Phase

Drug names

Primary outcome measures

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 trial start date

01/07/2009

Overall trial end date

30/06/2013

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Both

Target number of participants

85

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

United Kingdom

Trial participating centre

Oxfordshire Complex Needs Service
Oxford
OX4 1XE
United Kingdom

Sponsor information

Organisation

Oxfordshire and Buckinghamshire Mental Health NHS Foundation Trust (UK)

Sponsor details

Trust Headquarters
4000 John Smith Drive
Oxford Business Park South
Oxford
OX4 2GX
United Kingdom
+44 (0)1865 741717
Steve.Pearce@obmh.nhs.uk

Sponsor type

Government

Website

Funders

Funder type

Government

Funder name

Oxfordshire and Buckinghamshire Mental Health NHS Foundation Trust (UK)

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

Publication citations

Additional files

Editorial Notes

03/02/2016: No publications found, verifying study status with principal investigator