Condition category
Mental and Behavioural Disorders
Date applied
26/09/2006
Date assigned
26/09/2006
Last edited
10/03/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Ms L H Wolters

ORCID ID

Contact details

Academic Medical Center (AMC)
Department of Child and Adolescent Psychiatry
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands
+31 (0)20 5662242
L.h.wolters@amc.uva.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

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

Ethics approval

Ethics approval received from the local medical ethics committee

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

01/09/2006

Overall trial end date

01/01/2009

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

45

Participant 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

Recruitment start date

01/09/2006

Recruitment end date

01/01/2009

Locations

Countries of recruitment

Netherlands

Trial participating centre

Academic Medical Center (AMC)
Amsterdam
1105 AZ
Netherlands

Sponsor information

Organisation

Academic Medical Center (AMC) (The Netherlands)

Sponsor details

P.O. Box 22660
Amsterdam
1100 DD
Netherlands

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Academic Medical Center (AMC) (The Netherlands)

Alternative name(s)

Academic Medical Center, AMC

Funding Body Type

private sector organisation

Funding Body Subtype

academic

Location

Netherlands

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes