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
Secondary identifying numbers 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

Edenfield Centre
Bolton Salford & Trafford Mental Health NHS Trust
Prestwich
Manchester
M25 3BL
United Kingdom

Phone +44 (0)161 772 3855

Study information

Study designIndependent phase II Medical Research Council (MRC) framework exploratory trial using a randomised controlled trial methodology
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study acronymSchema Modal Therapy Trial
Study objectives1. 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) studiedPersonality Disorder
InterventionSubjects 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 typeOther
Primary outcome measurePersonal schemata
Secondary outcome measures1. Personality traits
2. Risk to others
3. Interpersonal style
4. Emotional regulation
5. Impulsiveness
Overall study start date01/11/2004
Completion date01/10/2009

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
Upper age limit70 Years
SexMale
Target number of participants60
Key inclusion criteria1. 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 criteria1. Current psychotic symptoms
2. Organic brain syndromes
3. Intelligence Quotient (IQ) less than 70
Date of first enrolment01/11/2004
Date of final enrolment01/10/2009

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Edenfield Centre
Manchester
M25 3BL
United Kingdom

Sponsor information

University of Manchester (UK)
University/education

Research Contracts Office
Oxford Road
Manchester
M13 9PL
England
United Kingdom

Email jane.wells@manchester.ac.uk
Website http://www.manchester.ac.uk/
ROR logo "ROR" https://ror.org/027m9bs27

Funders

Funder type

Government

Dangerous & Severe Personality Disorder (DSPD) Programme, Home Office (UK) (ref: RDS/03/152)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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