Condition category
Mental and Behavioural Disorders
Date applied
21/02/2006
Date assigned
05/05/2006
Last edited
22/05/2012
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

Prof Thomas Fahy

ORCID ID

Contact details

Forensic Mental Health Science
P O Box 23
Institute of Psychiatry
De Crespigny Park
London
SE5 8AF
United Kingdom
+44 (0)207 848 0151
t.fahy@iop.kcl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

03/0367

Study information

Scientific title

Acronym

Study hypothesis

To evaluate the effectiveness of the reasoning and rehabilitation (R & R) programme in reducing antisocial behaviour among mentally disordered offenders.

Ethics approval

Approved by Joint South London and Maudsley - Institute of Psychiatry Research Ethics Committee on 23/09/2004, reference number 111/04

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Schizophrenia or schizoaffective disorder

Intervention

Reasoning and rehabilitation programme versus treatment as usual

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Measures of antisocial and problematic behaviour

Secondary outcome measures

1. Crime pics II - measures change in attitude to offending
2. Rosezweig picture-frustration study - measures response to frustration and aggressive response to everyday stress
3. Gudjonsson blame attribution inventory - measures how offenders attribute blame for their criminal acts
4. Social problem solving inventory revised - self report measure of problem solving style
5. Historical, clinical and risk management-20 (HCR-20) - measures change in risk of violence to others
5. Davies reactivity scale - measures change in emotional responses
6. Novaco anger - measures change in irritability and anger to everyday stresses
7. Jumping to conclusions task - measures change in probabilistic reasoning

Overall trial start date

01/06/2004

Overall trial end date

31/05/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Male
2. Clinical diagnosis of schizophrenia or schizoaffective disorder
3. Inpatient of adult forensic mental health service
4. A history of violent behaviour leading to current treatment episode

Participant type

Patient

Age group

Adult

Gender

Male

Target number of participants

160

Participant exclusion criteria

1. Intelligence quotient (IQ) less than 70
2. Score of greater than 4 on one of the P scales of positive and negative syndrome scale (PANSS)
4. Previously undergone R & R or similar programme

Recruitment start date

01/06/2004

Recruitment end date

31/05/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Forensic Mental Health Science
London
SE5 8AF
United Kingdom

Sponsor information

Organisation

The Institute of Psychiatry (UK)

Sponsor details

Forensic Mental Health Science
P O Box 23
Institute of Psychiatry
De Crespigny Park
London
SE5 8AF
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

Forensic Mental Health Research and Development Programme (Department of Health)

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. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/21846425

Publication citations

  1. Results

    Cullen AE, Clarke AY, Kuipers E, Hodgins S, Dean K, Fahy T, A multi-site randomized controlled trial of a cognitive skills programme for male mentally disordered offenders: social-cognitive outcomes., Psychol Med, 2012, 42, 3, 557-569, doi: 10.1017/S0033291711001553.

Additional files

Editorial Notes