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

ISRCTN ISRCTN07851536
DOI https://doi.org/10.1186/ISRCTN07851536
Secondary identifying numbers N/A
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

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study objectivesInformation-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) studiedObsessive-Compulsive Disorder (OCD)
Intervention1. 16 weekly sessions Cognitive Behavioral Therapy (CBT)
2. Waitlist (eight weeks) followed by 16 weekly sessions CBT
Intervention typeOther
Primary outcome measure1. 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 measures1. 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
Overall study start date01/09/2006
Completion date01/01/2009

Eligibility

Participant type(s)Patient
Age groupChild
Lower age limit8 Years
Upper age limit18 Years
SexBoth
Target number of participants45
Key inclusion criteria1. 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 criteriaUse 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 enrolment01/09/2006
Date of final enrolment01/01/2009

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Academic Medical Center (AMC)
Amsterdam
1105 AZ
Netherlands

Sponsor information

Academic Medical Center (AMC) (The Netherlands)
Hospital/treatment centre

P.O. Box 22660
Amsterdam
1100 DD
Netherlands

ROR logo "ROR" https://ror.org/03t4gr691

Funders

Funder type

Hospital/treatment centre

Academic Medical Center (AMC) (The Netherlands)
Private sector organisation / Universities (academic only)
Alternative name(s)
Academic Medical Center, AMC
Location
Netherlands

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan