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17 May 2012
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| [ Print-friendly version ] |
| Information processing, neuropsychological, and neurobiological processes in pediatric obsessive-compulsive disorder |
| ISRCTN | ISRCTN07851536 |
| ClinicalTrials.gov identifier | |
| Public title | Information processing, neuropsychological, and neurobiological processes in pediatric obsessive-compulsive disorder |
| Scientific title | |
| Acronym | N/A |
| Serial number at source | N/A |
| Study hypothesis |
Information-processing:
1. Changes in measures of severity of Obsessive-Compulsive Disorder (OCD) are explained (partially) by changes in measures of meta-cognitions (explicit and/or implicit) 2. Changes in measures of meta-cognitions (explicit and implicit) precede changes in measures of severity of OCD Neuropsychological processes: 1. Changes in measures of severity of OCD are explained (partially) by changes in measures of inhibition of attentional processes 2. Changes in measures of inhibition precede changes in measures of severity of OCD Neurobiological processes: 1. Volumes of prefrontal cortex and striatum, activity of anterior cingulate, orbitofrontal region and striatum differ from healthy controls and change during treatment |
| Lay summary | |
| Ethics approval | Ethics approval received from the local medical ethics committee |
| Study design | Randomised controlled trial |
| Countries of recruitment | Netherlands |
| Disease/condition/study domain | Obsessive-Compulsive Disorder (OCD) |
| Participants - 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 |
| Participants - 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 |
| Anticipated start date | 01/09/2006 |
| Anticipated end date | 01/01/2009 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 45 |
| Interventions |
1. 16 weekly sessions Cognitive Behavioral Therapy (CBT)
2. Waitlist (eight weeks) followed by 16 weekly sessions CBT |
| Primary outcome measure(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 measure(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 |
| Sources of funding | Academic Medical Center (AMC) (The Netherlands) |
| Trial website | |
| Publications | |
| Contact name | Ms L H Wolters |
| Address |
Academic Medical Center (AMC)
Department of Child and Adolescent Psychiatry Meibergdreef 9 |
| City/town | Amsterdam |
| Zip/Postcode | 1105 AZ |
| Country | Netherlands |
| Tel | +31 (0)20 5662242 |
| Fax | +31 (0)20 6970091 |
| L.h.wolters@amc.uva.nl | |
| Sponsor | Academic Medical Center (AMC) (The Netherlands) |
| Address | P.O. Box 22660 |
| City/town | Amsterdam |
| Zip/Postcode | 1100 DD |
| Country | Netherlands |
| Date applied | 26/09/2006 |
| Last edited | 10/03/2008 |
| Date ISRCTN assigned | 26/09/2006 |
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