Information processing, neuropsychological, and neurobiological processes in pediatric obsessive-compulsive disorder
ISRCTN | ISRCTN07851536 |
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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
Scientific
Academic Medical Center (AMC)
Department of Child and Adolescent Psychiatry
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands
Phone | +31 (0)20 5662242 |
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L.h.wolters@amc.uva.nl |
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Treatment |
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 | 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 measures | 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 |
Overall study start date | 01/09/2006 |
Completion date | 01/01/2009 |
Eligibility
Participant type(s) | Patient |
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Age group | Child |
Lower age limit | 8 Years |
Upper age limit | 18 Years |
Sex | Both |
Target number of participants | 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
1105 AZ
Netherlands
Sponsor information
Academic Medical Center (AMC) (The Netherlands)
Hospital/treatment centre
Hospital/treatment centre
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
https://ror.org/03t4gr691 |
Funders
Funder type
Hospital/treatment centre
Academic Medical Center (AMC) (The Netherlands)
Private sector organisation / Universities (academic only)
Private sector organisation / Universities (academic only)
- Alternative name(s)
- Academic Medical Center, AMC
- Location
- Netherlands
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |