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

ISRCTN	ISRCTN87114880
DOI	https://doi.org/10.1186/ISRCTN87114880
Secondary identifying numbers	N/A

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

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Participant information sheet	Information sheet for young people age 14-16 years, for their parents, and for adult participants all available on request at the contact details below.
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	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
Secondary outcome measures	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
Overall study start date	01/03/2007
Completion date	01/03/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	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

England
United Kingdom

Study participating centre

Po 77 Institute of Psychiatry

London
SE5 4AF
United Kingdom

Sponsor information

Kings College London, Institute of Psychiatry (UK)
University/education

PO 77
Denmark Hill
London
London
SE5 4AF
England
United Kingdom

Website	http://www.iop.kcl.ac.uk/
"ROR"	https://ror.org/0220mzb33

Funders

Funder type

Research organisation

Kings College London, Institute of Psychiatry (UK)

No information available

South London and Maudsley NHS Trust (UK)

No information available

Results and Publications

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

Study outputs

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