Condition category
Mental and Behavioural Disorders
Date applied
06/01/2008
Date assigned
21/04/2008
Last edited
18/11/2013
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

Miss Ailsa Russell

ORCID ID

Contact details

Po 77 Institute of Psychiatry
Kings College London
Denmark Hill
London
SE5 4AF
United Kingdom
+44 (0)20 7848 0655
a.russell@iop.kcl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Is cognitive behaviour therapy an effective treatment for obsessive compulsive disorder in people with high functioning autism spectrum disorders?

Acronym

Study hypothesis

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

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)

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

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.

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

01/03/2007

Overall trial end date

01/03/2009

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

40

Participant exclusion criteria

1. Current acute symptoms of psychosis
2. Uncontrolled seizure disorder or substance misuse disorder

Recruitment start date

01/03/2007

Recruitment end date

01/03/2009

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Po 77 Institute of Psychiatry
London
SE5 4AF
United Kingdom

Sponsor information

Organisation

Kings College London, Institute of Psychiatry (UK)

Sponsor details

PO 77
Denmark Hill
London
London
SE5 4AF
United Kingdom

Sponsor type

University/education

Website

http://www.iop.kcl.ac.uk/

Funders

Funder type

Research organisation

Funder name

Kings College London, Institute of Psychiatry (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

South London and Maudsley NHS Trust (UK)

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

2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23389964

Publication citations

  1. Results

    Russell AJ, Jassi A, Fullana MA, Mack H, Johnston K, Heyman I, Murphy DG, Mataix-Cols D, Cognitive behavior therapy for comorbid obsessive-compulsive disorder in high-functioning autism spectrum disorders: a randomized controlled trial., Depress Anxiety, 2013, 30, 8, 697-708, doi: 10.1002/da.22053.

Additional files

Editorial Notes