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

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

Sponsor information

Organisation

Academic Medical Center (AMC) (The Netherlands)

Sponsor details

P.O. Box 22660
Amsterdam
1100 DD
Netherlands

Sponsor type

University/education

Website

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

Publication citations

Additional files

Editorial Notes