|- candidate number||2147|
|- NTR Number||NTR717|
|- Date ISRCTN created||26-sep-2006|
|- date ISRCTN requested||13-sep-2006|
|- Date Registered NTR||27-jun-2006|
|- Secondary IDs||N/A |
|- Public Title||Information processing, neuropsychological, and neurobiological processes in pediatric obsessive-compulsive disorder.|
|- Scientific Title||Information processing, neuropsychological, and neurobiological processes in pediatric obsessive-compulsive disorder and treatment effects of cognitive behavioral therapy.|
1. Changes in measures of severity of 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.
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.
1. Volumes of prefrontal cortex and striatum, activity of anterior cingulate, orbitofrontal region and striatum differ from healthy controls and change during treatment.|
|- Healt Condition(s) or Problem(s) studied||Obsessive-compulsive disorder (OCD)|
|- Inclusion criteria||1. Children and adolescents 8 - 18 years;
2. Primary diagnosis: Obsessive Compulsive Disorder (OCD);
3. OCD symptoms for more than 6 months;
4. CY-BOCS total score > 16;
5. IQ > 80;
6. Informed consent of parents and child.|
|- Exclusion criteria||Use of the following medication:
3. Anti-psychotic medication.
For neurobiological measures (fMRI):
2. Metal on body.|
|- mec approval received||yes|
|- multicenter trial||no|
|- control||Not applicable|
|- planned startdate ||1-sep-2006|
|- planned closingdate||1-jan-2009|
|- Target number of participants||45|
|- Interventions||1. 16 weekly sessions Cognitive Behavioral Therapy (CBT);
2. Waitlist (8 weeks) followed by 16 weekly sessions CBT.
|- Primary outcome||1. Severity of OCD (CY-BOCS; measured at the start of the waitlist condition, directly before start of the CBT, session 4, 8, 12 and 16 and follow up after 16 weeks);
2. Anxiety / Depression (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||1. Information-processing (explicit: OBQ-44 R, MCQ-A; Implicit: EAST) (measured at the start of the waitlist, directly before start of the CBT, session 8 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 8 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.|
|- Trial web site||N/A|
|- status||stopped: trial finished|
|- CONTACT FOR PUBLIC QUERIES|| L.H. Wolters|
|- CONTACT for SCIENTIFIC QUERIES||PhD. Else Haan, de|
|- Sponsor/Initiator ||Academic Medical Center (AMC)|
(Source(s) of Monetary or Material Support)
|Academic Medical Center (AMC)|
|- Brief summary||For Pediatric Obsessive-Compulsive Disorder (OCD) cognitive behavioral therapy (CBT) (with or without SSRI) is the initial treatment of choice. This treatment is found to be moderately effective. However, working mechanisms of CBT are unclear. Models on which CBT is based are hardly studied in children and adolescents. Knowledge about these issues is needed to improve treatment of OCD.
Cognitive theories propose that dysfunctional cognitions play a maintaining or even etiological role in OCD. Other theorists assume that a domain-specific deficit in the ability to inhibit impulses is the core problem of OCD. Furthermore, from a neurobiologically perspective, deviations in the prefrontal-striatal-thalamic circuit are considered to play a centrol role in the development and maintenance of OCD.
The purpose of this study is to determine some information-processing, neuropsychological and neurobiological mechanisms that contribute to the development and maintenance of OCD and/or mediate cognitive-behavioral treatment of OCD. |
|- Main changes (audit trail)|
|- RECORD||27-jun-2006 - 6-nov-2013|