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ISRCTN
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ISRCTN87114880
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ClinicalTrials.gov identifier
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Public title
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Cognitive behaviour therapy for co-morbid obsessive compulsive disorder in autism spectrum disorder
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Scientific title
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Is cognitive behaviour therapy an effective treatment for obsessive compulsive disorder in people with high functioning autism spectrum disorders?
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Acronym
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N/A
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Serial number at source
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N/A
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Study hypothesis
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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.
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Ethics approval
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Joint South London and Maudsley and the Institute of Psychiatry NHS Research Ethics Committee. Date of approval: 10/08/2006 (ref: 06/Q0706/22)
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Study design
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Randomised controlled trial.
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Countries of recruitment
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United Kindgom
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Disease/condition/study domain
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Disabling obsessions and compulsions in autism spectrum disorders
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Participants - inclusion criteria
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1. Male and female, aged 14 years or older to a maximum of 65 years old
2. Verbal IQ >70
3. Diagnoses of ASD and co-morbid OCD
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Participants - exclusion criteria
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1. Current acute symptoms of psychosis
2. Uncontrolled seizure disorder or substance misuse disorder
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Anticipated start date
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01/03/2007
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Anticipated end date
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01/03/2009
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Status of trial
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Ongoing
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Patient information material
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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.
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Target number of participants
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40
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Interventions
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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.
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Primary outcome measure(s)
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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
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Secondary outcome measure(s)
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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
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Sources of funding
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1. Kings College London, Institute of Psychiatry (UK)
2. South London and Maudsley NHS Trust (UK)
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Trial website
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http://www.nas.org.uk/nas/jsp/polopoly.jsp?d=567&a=13311
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Publications
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Contact name
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Miss
Ailsa
Russell
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Address
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Po 77 Institute of Psychiatry
Kings College London
Denmark Hill
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City/town
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London
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Zip/Postcode
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Se5 4Af
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Country
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United Kingdom
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Tel
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+44 (0)207 848 0655
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Email
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a.russell@iop.kcl.ac.uk
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Sponsor
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Kings College London, Institute of Psychiatry (UK)
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Address
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PO 77
Denmark Hill
London
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City/town
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London
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Zip/Postcode
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SE24 9BA
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Country
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United Kingdom
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Date applied
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06/01/2008
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Last edited
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22/04/2008
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Date ISRCTN assigned
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21/04/2008
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