Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
RDS/03/152
Study information
Scientific title
Acronym
Schema Modal Therapy Trial
Study hypothesis
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
Approval received from the Liverpool (Adult) Local Research Ethics Committee on the 28th April 2004 (ref: 04/02/324/A).
Study design
Independent phase II Medical Research Council (MRC) framework exploratory trial using a randomised controlled trial methodology
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Phase II
Drug names
Primary outcome measure
Personal schemata
Secondary outcome measures
1. Personality traits
2. Risk to others
3. Interpersonal style
4. Emotional regulation
5. Impulsiveness
Overall trial start date
01/11/2004
Overall trial end date
01/10/2009
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Male
Target number of participants
60
Participant exclusion criteria
1. Current psychotic symptoms
2. Organic brain syndromes
3. Intelligence Quotient (IQ) less than 70
Recruitment start date
01/11/2004
Recruitment end date
01/10/2009
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Edenfield Centre
Manchester
M25 3BL
United Kingdom
Sponsor information
Organisation
University of Manchester (UK)
Sponsor details
Research Contracts Office
Oxford Road
Manchester
M13 9PL
United Kingdom
jane.wells@manchester.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
Dangerous & Severe Personality Disorder (DSPD) Programme, Home Office (UK) (ref: RDS/03/152)
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
Basic results (scientific)
Publication list
1. 2010 results in http://www.justice.gov.uk/publications/research-and-analysis/moj/2010/schema-modal-therapy-research