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

ISRCTN	ISRCTN07851536
DOI	https://doi.org/10.1186/ISRCTN07851536
Protocol serial number	N/A
Sponsor	Academic Medical Center (AMC) (The Netherlands)
Funder	Academic Medical Center (AMC) (The Netherlands)

Submission date: 26/09/2006
Registration date: 26/09/2006
Last edited: 10/03/2008

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Ms L H Wolters
Scientific

Academic Medical Center (AMC)
Department of Child and Adolescent Psychiatry
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands

Phone	+31 (0)20 5662242
Email	L.h.wolters@amc.uva.nl

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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
Ethics approval(s)	Ethics approval received from the local medical ethics committee
Health condition(s) or problem(s) studied	Obsessive-Compulsive Disorder (OCD)
Intervention	1. 16 weekly sessions Cognitive Behavioral Therapy (CBT) 2. Waitlist (eight weeks) followed by 16 weekly sessions CBT
Intervention type	Other
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)
Key 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
Completion date	01/01/2009

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	8 Years
Upper age limit	18 Years
Sex	All
Target sample size at registration	45
Key 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
Key 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
Date of first enrolment	01/09/2006
Date of final enrolment	01/01/2009

Locations

Countries of recruitment

Netherlands

Study participating centre

Academic Medical Center (AMC)

Amsterdam
1105 AZ
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan