Condition category
Mental and Behavioural Disorders
Date applied
20/03/2009
Date assigned
31/03/2009
Last edited
08/02/2016
Prospective/Retrospective
Prospectively 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 Mike Crawford

ORCID ID

Contact details

Department of Psychological Medicine
Imperial College London
Claybrook Centre
37 Claybrook Road
London
W6 8LN
United Kingdom
+44 (0)20 7386 1231
m.crawford@imperial.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Version 3.0 27th January 2009

Study information

Scientific title

Controlled Randomised Evaluation of group Art Therapy for people with personality disorder

Acronym

CREATe

Study hypothesis

Among people with personality disorder, those randomised to referral for arts therapies plus treatment as usual will have improved mental health, as measured by the Clinical Outcome in Routine Evaluation (CORE) at 30 months, compared to those receiving treatment as usual alone.

Ethics approval

Ealing and West London Research Ethics Committee, 02/03/2009, ref: 08/H0710/86

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Personality disorder

Intervention

Weekly group art psychotherapy for up to 24 months versus treatment as usual.

Treatment as usual will conform to standards laid down in draft national guidance on the management of people with borderline personality disorder (National Institute for Clinical Excellence 2008) and be based on regular out-patient review. This will take place at least once every three months. Other elements of treatment as usual will vary depending on patient needs but in all cases it will include; consideration of psychotropic medication, and the option of referral to crisis team and inpatient psychiatric treatment.

The total duration of follow-up is 30 months.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Clinical Outcomes Routine Evaluation at 30 months

Secondary outcome measures

1. Mental health measured using the CORE at 6 and 18 months
2. Social functioning measures using the Social Functioning Questionnaire at 6, 18 and 30 months
3. Satisfaction with care using the 8-item Client Satisfaction Questionnaire at 6, 18 and 30 months
4. Quality of life using Euro-Qol at 6, 18 and 30 months
5. Frequency of suicidal acts and acts of deliberate self harm collected via a self-report questionnaire developed specifically for the study and measured at at 6, 18 and 30 months
6. Direct costs (healthcare and non-health care) and productivity costs will be calculated for at 18 and 30 months. Service utilisation data will be collected via a self-report questionnaire developed specifically for the study
7. Global Assessment of Functioning a 100-point single item, observer-rated scale that rates functioning on a continuum from health to illness rated at 6, 18 and 30 months

Overall trial start date

01/04/2009

Overall trial end date

30/09/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. Either sex, aged 18 to 70 years
2. Living in the London Boroughs of Kensington and Chelsea or Westminster
3. Have a primary diagnosis of personality disorder (PD)
4. Referred to the Waterview Centre
5. Have a diagnosis of PD confirmed using the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders (SCID-II)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

50

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. Already in receipt of art, music or another arts therapy
3. Currently being treated on a compulsory basis (under the Mental Health Act)
4. Unwilling to provide written informed consent to participate in the trial

Recruitment start date

01/04/2009

Recruitment end date

30/09/2013

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Psychological Medicine
London
W6 8LN
United Kingdom

Sponsor information

Organisation

Imperial College London

Sponsor details

Faculty of Medicine
G02 Sir Alexander Fleming Building
South Kensington Campus
London
SW7 2AZ
United Kingdom
+44 (0)20 7594 1872
gary.roper@imperial.ac.uk

Sponsor type

University/education

Website

http://www3.imperial.ac.uk/

Funders

Funder type

Hospital/treatment centre

Funder name

Central and North West London NHS Foundation Trust

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

08/02/2016: No publications found, verifying study status with principal investigator