Condition category
Mental and Behavioural Disorders
Date applied
16/08/2005
Date assigned
07/10/2005
Last edited
20/08/2009
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 Kate Davidson

ORCID ID

Contact details

Psychological Medicine
Gartnavel Royal Hospital
1055 Great Western Road
Glasgow
G12 0XH
United Kingdom
+44 (0)141 211 3908/3900
k.davidson@clinmed.gla.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

G0400922 ID: 71697

Study information

Scientific title

Acronym

ASCOT

Study hypothesis

This pilot study has four specific and related aims.
1. Development of treatment
2. Chart treatment as usual
3. Test out standardised measures and different modes of delivery if levels of literacy are found to be poor
4. Determine a preliminary efficacy estimate for CBT in this group

Ethics approval

Added as of 13/08/2007:
1. Ethics Board for lead site: NHS Greater Glasgow Primary Care Trust (Community and Mental Health), approved on 16/05/2005 (ref: 05/S0701/46)

Other sites:
2. St Mary's Research Ethics Committee, approved on 10/06/2005
3. Ealing and West London Mental Health Trust (WLMHT) Local Research Ethics Committee, approved on 17/11/2005

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

Condition

Antisocial Personality Disorder

Intervention

Cognitive behaviour therapy versus usual treatment

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Aggression & offending behaviour

Secondary outcome measures

1. Social functioning
2. Anxiety and depression
3. Anger
4. Cost effectiveness

Overall trial start date

13/09/2005

Overall trial end date

12/09/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. A diagnosis of ASPD with aggressive behaviour
2. Aged 18 or above
3. Affirmation of any item on the Amended MacArthur Community Violence Screening Instrument (MCVSI)* interview (*3 months prior to baseline)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

56 - closed to recruitment - in follow-up

Participant exclusion criteria

1. Those who are currently receiving inpatient treatment for a mental state disorder
2. Those currently receiving a systematic psychological therapy
3. Those who have insufficient knowledge of English to enable them to be assessed adequately and to understand the treatment approach

Recruitment start date

13/09/2005

Recruitment end date

12/09/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Psychological Medicine
Glasgow
G12 0XH
United Kingdom

Sponsor information

Organisation

Greater Glasgow NHS (UK)

Sponsor details

Research and Development
Gartnavel Royal Hospital
1055 Great Western Road
Glasgow
G12 0XH
United Kingdom

Sponsor type

Government

Website

Funders

Funder type

Research council

Funder name

Medical Research Council (MRC) (UK) (G0400922)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

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

2009 results in http://www.ncbi.nlm.nih.gov/pubmed/18667099

Publication citations

  1. Results

    Davidson KM, Tyrer P, Tata P, Cooke D, Gumley A, Ford I, Walker A, Bezlyak V, Seivewright H, Robertson H, Crawford MJ, Cognitive behaviour therapy for violent men with antisocial personality disorder in the community: an exploratory randomized controlled trial., Psychol Med, 2009, 39, 4, 569-577, doi: 10.1017/S0033291708004066.

Additional files

Editorial Notes