Pilot study of Cognitive Behaviour Therapy (CBT) versus usual treatment in those with Antisocial Personality Disorder (ASPD) with aggressive behaviour

ISRCTN	ISRCTN89922377
DOI	https://doi.org/10.1186/ISRCTN89922377
Secondary identifying numbers	G0400922 ID: 71697

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Prof Kate Davidson
Scientific

Psychological Medicine
Gartnavel Royal Hospital
1055 Great Western Road
Glasgow
G12 0XH
United Kingdom

Phone	+44 (0)141 211 3908/3900
Email	k.davidson@clinmed.gla.ac.uk

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title
Study acronym	ASCOT
Study objectives	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(s)	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
Health condition(s) or problem(s) studied	Antisocial Personality Disorder
Intervention	Cognitive behaviour therapy versus usual treatment
Intervention type	Other
Primary outcome measure	Aggression & offending behaviour
Secondary outcome measures	1. Social functioning 2. Anxiety and depression 3. Anger 4. Cost effectiveness
Overall study start date	13/09/2005
Completion date	12/09/2007

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	56 - closed to recruitment - in follow-up
Key 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)
Key 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
Date of first enrolment	13/09/2005
Date of final enrolment	12/09/2007

Psychological Medicine

Glasgow
G12 0XH
United Kingdom

Greater Glasgow NHS (UK)
Government

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

"ROR"	https://ror.org/05kdz4d87

Research council

Medical Research Council (MRC) (UK) (G0400922)
Government organisation / National government

Alternative name(s): Medical Research Council (United Kingdom), UK Medical Research Council, MRC
Location: United Kingdom

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/04/2009		Yes	No