Contact information
Type
Scientific
Primary contact
Professor F Boer
ORCID ID
Contact details
Academic Medical Center (AMC)
Department of Child and Adolescent Psychiatry/de Bascule
PO Box 12474
Amsterdam
1100 AL
Netherlands
+31 (0)20 5663383
f.boer@amc.uva.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
1. Changes in outcome measures of anxiety can be partly explained by changes in:
a. self-reported thoughts
b. selective attention and by changes in fear relevant cognitive schema's
2. Changes in outcome measures of anxiety can be partly explained by changes in:
a. self-reported emotion regulation strategies
b. processes of attention regulation and by changes in underlying schema's of 'perceived control'
3. Effortful control will moderate the treatment effect
4. Executive functions will moderate the relation between mediators and the treatment effect. The treatment effect will be larger when executive functions are more developed
5. Stress-reactivity will moderate the treatment effect
6. Stress-reactivity is a vulnerability factor for developing an anxiety disorder and is an effect of an anxiety disorder
7. Part of the variance in treatment effect can be explained by family characteristics (parents psychopathology and parenting style) and characteristics of the therapist
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
Anxiety disorders
Intervention
Group one: 12 sessions of Cognitive Behavioural Therapy (CBT) according to the Coping Cat manual.
Four measure points: before therapy, after eight sessions, after therapy and after 12 week follow-up period.
Group two: Eight week Waiting List (WL) group. Children will receive the same therapy as group one after the waiting period.
Five measure points: before waiting list, before therapy, after eight sessions of therapy, after therapy and after 12 week follow-up period
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
1. Effect of treatment (diagnosis of anxiety disorder and scores on anxiety questionnaires)
2. Mediating effect of information processing
3. Mediating effect of emotion regulation
4. Moderating effect of effortful control, executive functions and stress-reactivity
Secondary outcome measures
1. Correlation between explicit and implicit measures
2. Development of implicit measures
Overall trial start date
01/09/2006
Overall trial end date
01/09/2008
Reason abandoned
Eligibility
Participant inclusion criteria
1. Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) anxiety disorder as primary diagnosis
2. Age between seven and 18 years
3. Intelligence Quotient (IQ) more than or equal to 80
4. Informed consent from parents and child
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
120
Participant exclusion criteria
1. Psychosis
2. Obsessive compulsive disorder as primary disorder
3. Post-traumatic stress disorder as primary disorder
4. Acute stress disorder
5. Drug and/or alcohol problems
6. Selective mutism
7. Current treatment with Selective Serotonin Reuptake Inhibitor (SSRI) or treatment with SSRI within half a year before inclusion
8. Psychotherapeutic treatment within the last half year
Recruitment start date
01/09/2006
Recruitment end date
01/09/2008
Locations
Countries of recruitment
Netherlands
Trial participating centre
Academic Medical Center (AMC)
Amsterdam
1100 AL
Netherlands
Funders
Funder type
University/education
Funder name
University of Amsterdam (UvA), Department of Clinical Psychology (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Accare (The Netherlands)
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
Netherlands
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