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
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