Cognitive behaviour therapy for co-morbid obsessive compulsive disorder in autism spectrum disorder

ISRCTN	ISRCTN87114880
DOI	https://doi.org/10.1186/ISRCTN87114880
Protocol serial number	N/A
Sponsor	Kings College London, Institute of Psychiatry (UK)
Funders	Kings College London, Institute of Psychiatry (UK), South London and Maudsley NHS Trust (UK)

Submission date: 06/01/2008
Registration date: 21/04/2008
Last edited: 18/11/2013

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Miss Ailsa Russell
Scientific

Po 77 Institute of Psychiatry
Kings College London
Denmark Hill
London
SE5 4AF
United Kingdom

Phone	+44 (0)20 7848 0655
Email	a.russell@iop.kcl.ac.uk

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Is cognitive behaviour therapy an effective treatment for obsessive compulsive disorder in people with high functioning autism spectrum disorders?
Study objectives	That cognitive behaviour therapy (CBT) will prove more effective in ameliorating obsessive compulsive disorder (OCD) symptoms in people with autism spectrum disorder (ASD) than an alternative treatment - stress management.
Ethics approval(s)	Ethics approval received from the Joint South London and Maudsley and the Institute of Psychiatry NHS Research Ethics Committee on the 10/08/2006 (ref: 06/Q0706/22)
Health condition(s) or problem(s) studied	Disabling obsessions and compulsions in autism spectrum disorders
Intervention	Intervention treatment: CBT for obsessive compulsive disorder (OCD) Control treatment: Stress management Both treatments contain a significant psycho-educational component about anxiety. The CBT for OCD treatment comprises cognitive and behavioural treatments for OCD including exposure and response prevention. Those participants allocated to the 'control' treatment will be permitted to crossover. Average duration of each session is 1 hour. Both treatments comprise up to 20 sessions of individual therapy. There is no minimum number of sessions as participants are free to leave the study at any time they wish. In general, the participants receive 1 session per week of treatment, although some participants have more intensive treatment (2 - 3 sessions per week). Therefore, the total duration of intervention depends on each participant.
Intervention type	Other
Primary outcome measure(s)	The following will be assessed at baseline (pre-treatment), end of treatment, 1, 3 and 6 months follow-up: 1. The Dimensional Yale Brown Obsessive Compulsive Scale (D-YBOCS) 2. The Obsessive Compulsive Inventory Revised (OCI-R) or Childrens Obsessive Compulsive Inventory (CH-OCI) 3. Beck Depression and Anxiety Scales or Spence Children's Anxiety Scale 4. Clinical Global Impressions Scale
Key secondary outcome measure(s)	The following will be assessed at baseline (pre-treatment), end of treatment, 1, 3 and 6 months follow-up: 1. Liebowitz Social Anxiety Scale 2. Family Accommodation Scale 3. Work/School and Social adjustment scale 4. Parental CH-OCI
Completion date	01/03/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	40
Key inclusion criteria	1. Male and female, aged 14 years or older to a maximum of 65 years old 2. Verbal intelligence quotient (IQ) greater than 70 3. Diagnoses of ASD and co-morbid OCD
Key exclusion criteria	1. Current acute symptoms of psychosis 2. Uncontrolled seizure disorder or substance misuse disorder
Date of first enrolment	01/03/2007
Date of final enrolment	01/03/2009

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Po 77 Institute of Psychiatry

London
SE5 4AF
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/08/2013		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes