Controlled randomised evaluation of group art therapy

ISRCTN	ISRCTN74217860
DOI	https://doi.org/10.1186/ISRCTN74217860
Secondary identifying numbers	Version 3.0 27/01/2009

Submission date: 20/03/2009
Registration date: 31/03/2009
Last edited: 23/03/2018

Recruitment status: Stopped
Overall study status: Stopped
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Mike Crawford
Scientific

Department of Psychological Medicine
Imperial College London
Claybrook Centre
37 Claybrook Road
London
W6 8LN
United Kingdom

ORCID ID	0000-0003-3137-5772
Phone	+44 (0)20 7386 1231
Email	m.crawford@imperial.ac.uk

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	Not available in web format, please use the contact details to request a patient information sheet
Scientific title	Controlled Randomised Evaluation of group Art Therapy for people with personality disorder
Study acronym	CREATe
Study objectives	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(s)	Ealing and West London Research Ethics Committee, 02/03/2009, ref: 08/H0710/86
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/04/2009
Completion date	30/09/2013
Reason abandoned (if study stopped)	Participant recruitment issue

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	50
Key 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)
Key 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
Date of first enrolment	01/04/2009
Date of final enrolment	30/09/2013

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Imperial College London

London
W6 8LN
United Kingdom

Sponsor information

Imperial College London
University/education

Faculty of Medicine
G02 Sir Alexander Fleming Building
South Kensington Campus
London
SW7 2AZ
England
United Kingdom

Phone	+44 (0)20 7594 1872
Email	gary.roper@imperial.ac.uk
Website	http://www3.imperial.ac.uk/
"ROR"	https://ror.org/041kmwe10

Funders

Funder type

Hospital/treatment centre

Central and North West London NHS Foundation Trust

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

Editorial Notes

23/03/2018: The trial was stopped (abandoned) due to poor recruitment.
08/02/2016: No publications found, verifying study status with principal investigator.