Condition category
Mental and Behavioural Disorders
Date applied
01/11/2006
Date assigned
13/02/2007
Last edited
04/09/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Mairead Dolan

ORCID ID

Contact details

Edenfield Centre
Bolton Salford & Trafford Mental Health NHS Trust
Prestwich
Manchester
M25 3BL
United Kingdom
+44 (0)161 772 3855

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 measures

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

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

http://www.manchester.ac.uk/

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

Results - basic reporting

Publication summary

1. 2010 results in http://www.justice.gov.uk/publications/research-and-analysis/moj/2010/schema-modal-therapy-research

Publication citations

Additional files

Editorial Notes