Evaluation of a cognitive-behavioural (schema-focused) therapy in the personality disorder service at Ashworth Hospital
| ISRCTN | ISRCTN89423966 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN89423966 |
| Protocol serial number | RDS/03/152 |
| Sponsor | University of Manchester (UK) |
| Funder | Dangerous & Severe Personality Disorder (DSPD) Programme, Home Office (UK) (ref: RDS/03/152) |
- Submission date
- 01/11/2006
- Registration date
- 13/02/2007
- Last edited
- 04/09/2012
- 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 of protocol
Not provided at time of registration
Contact information
Dr Mairead Dolan
Scientific
Scientific
Edenfield Centre
Bolton Salford & Trafford Mental Health NHS Trust
Prestwich
Manchester
M25 3BL
United Kingdom
| Phone | +44 (0)161 772 3855 |
|---|
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Independent phase II Medical Research Council (MRC) framework exploratory trial using a randomised controlled trial methodology |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | Schema Modal Therapy Trial |
| Study objectives | 1. That the enhanced Cognitive-Behavioural Therapy (CBT) intervention with a focus on personal schema will result in a statistically significant improvement in scores on dynamic measures of risk and cognitive, affective and behavioural dispositions of relevance to antisocial behaviour (Antisocial Personality Questionnaire [APQ]) on an individual and group basis compared with 'Treatment As Usual' (TAU) models of care 2. That a Schema-Focused (SF) approach will result in lower rates of attrition from therapy due to the nature of this work, than TAU approaches 3. That observed improvements in levels of functioning will be maintained at six and 12 months follow-up within the institution |
| Ethics approval(s) | Approval received from the Liverpool (Adult) Local Research Ethics Committee on the 28th April 2004 (ref: 04/02/324/A). |
| Health condition(s) or problem(s) studied | Personality Disorder |
| Intervention | Subjects will be randomly assigned to the 'Treatment As Usual' (TAU) group versus the enhanced CBT group (TAU or SF-CBT). Randomisation will take place in such a way that each of the clinical teams managing cases will have an equal number of cases in the TAU and SF-CBT groups. Randomisation will be conducted, independently, by a remote telephone randomisation service. |
| Intervention type | Other |
| Primary outcome measure(s) |
Personal schemata |
| Key secondary outcome measure(s) |
1. Personality traits |
| Completion date | 01/10/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 70 Years |
| Sex | Male |
| Target sample size at registration | 60 |
| Key inclusion criteria | 1. Male personality disorder patients 2. Aged between 18 and 70 years 3. Currently a resident at Ashworth Hospital; new admissions will also be included in the study if they are allocated to stay for the duration of the treatment intervention |
| Key exclusion criteria | 1. Current psychotic symptoms 2. Organic brain syndromes 3. Intelligence Quotient (IQ) less than 70 |
| Date of first enrolment | 01/11/2004 |
| Date of final enrolment | 01/10/2009 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Edenfield Centre
Manchester
M25 3BL
United Kingdom
M25 3BL
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Funder report results | results | 01/03/2010 | No | No |
