Information processing, neuropsychological, and neurobiological processes in pediatric obsessive-compulsive disorder

• Register: ISRCTN
• Last refreshed on: 13 January 2015
• Main ID: ISRCTN07851536
• Date of registration: 26/09/2006
• Prospective Registration: No
• Primary sponsor: Academic Medical Center (AMC) (The Netherlands)
• Public title: Information processing, neuropsychological, and neurobiological processes in pediatric obsessive-compulsive disorder
• Date of first enrolment: 01/09/2006
• Target sample size: 45
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN07851536
• Study type: Interventional
• Study design: Randomised controlled trial (Treatment)

Countries of recruitment

Netherlands

Contacts

• Name: L H Wolters

Key inclusion & exclusion criteria

Inclusion criteria: 1. Children and adolescents eight to 18 years
2. Primary diagnosis: Obsessive Compulsive Disorder (OCD)
3. OCD symptoms for more than six months
4. Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) total score more than 16
5. IQ (Intelligence Quotient) more than 80
6. Informed consent of parents and child
Exclusion criteria: Use of the following medication:
1. Selective Serotonin Reuptake Inhibitor (SSRI)
2. Tricyclic Antidepressant (TCA)
3. Anti-psychotic medication

For neurobiological measures (functional Magnetic Resonance Imaging [fMRI]):
1. Claustrophobia
2. Metal on body

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Obsessive-Compulsive Disorder (OCD)
Mental and Behavioural Disorders
Obsessive Compulsive Disorder (OCD)

Intervention(s)

1. 16 weekly sessions Cognitive Behavioral Therapy (CBT)
2. Waitlist (eight weeks) followed by 16 weekly sessions CBT

Primary Outcome(s)

1. Severity of OCD (CY-BOCS, measured at the start of the waitlist condition, directly before start of the CBT, session eight, 16 and follow up after 16 weeks)
2. Anxiety/Depression (Revised Child and Anxiety Depression Scale [RCADS]) measured at the start of the waitlist, directly before start of the CBT, at the end of the therapy (session 16) and follow up after 16 weeks)

Secondary Outcome(s)

1. Information-processing (explicit: Revised 44 item version of the Obsessive-Beliefs Questionnaire scale [OBQ-44 R], Meta-Cognitions Questionnaire for Adolescents [MCQ-A], Implicit: Implicit Association Procedure [IAP]) (measured at the start of the waitlist, directly before start of the CBT, session eight and 16 and follow up after 16 weeks)
2. Inhibition/selective attention (dot-probe, measured at the start of the waitlist, directly before start of the CBT, session eight and 16 and follow up after 16 weeks)
3. Neuroimaging data: volumes grey and white matter, activity on planning (tower of London), selective attention (Flanker) and inhibition (dot-probe) task in fMRI

Secondary ID(s)

N/A

Source(s) of Monetary Support

Academic Medical Center (AMC) (The Netherlands)