Condition category
Mental and Behavioural Disorders
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
06/04/2011
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 Adelinde J.M. van der Leeden

ORCID ID

Contact details

Academisch Centrum Kinder - en Jeugdpsychiatrie Curium
Endegeesterstraatweg 27
Oegstgeest
2342 AK
Netherlands
+31 (0)71 515 9600
A.J.M.van.der.Leeden@umail.leidenuniv.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

5484 (NFGV); NTR347

Study information

Scientific title

Acronym

Study hypothesis

1. Group cognitive behavioural treatment is as effective as individual cognitive behavioural treatment
2. Treatment outcome is predicted by severity of the psychopathology, cognitive variables, social variables, biological variables and environmental variables
3. Children diagnosed with an anxiety disorder after the first phase of treatment will respond to prolongation of the treatment with active participation of parents

Ethics approval

Received from the local medical ethics committee

Study design

Randomised, active controlled, parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Anxiety disorders

Intervention

1. Individual cognitive behavioural treatment
2. Group cognitive behavioural treatment

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Diagnostic status
2. Anxiety symptoms

Secondary outcome measures

1. Depressive symptoms
2. Other symptoms of psychopathology
3. Global level of functioning

Overall trial start date

01/09/2002

Overall trial end date

01/12/2006

Reason abandoned

Eligibility

Participant inclusion criteria

1. Children and adolescents between 8 and 16 years old
2. Primary diagnosed with at least one of following Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM IV) anxiety disorders: separation anxiety disorder, social phobia, generalised anxiety disorder or specific phobia

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

180

Participant exclusion criteria

1. Intelligence Quotient (IQ) less than 85
2. Children who are not proficient in the Dutch language
3. Somatic disease
4. Drug related disorder
5. Pervasive developmental disorder
6. Selective mutism
7. Psycho-somatic disease
8. Schizophrenia or other psychotic disorder
9. Obsessive compulsive disorder
10. Post-traumatic stress disorder
11. Acute stress disorder
12. Use of medication for anxiety
13. Concurrent psychotherapy

Recruitment start date

01/09/2002

Recruitment end date

01/12/2006

Locations

Countries of recruitment

Netherlands

Trial participating centre

Academisch Centrum Kinder - en Jeugdpsychiatrie Curium
Oegstgeest
2342 AK
Netherlands

Sponsor information

Organisation

Leiden University Medical Centre (LUMC) (Netherlands)

Sponsor details

Albinusdreef 2
P.O. Box 9600
Leiden
2300 RC
Netherlands

Sponsor type

University/education

Website

http://www.lumc.nl/

Funders

Funder type

Hospital/treatment centre

Funder name

Leiden University Medical Centre (LUMC) (The Netherlands) - Revolving Fund

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

National Fund for Public Mental Health (Nationaal Fonds Geestelijke Volksgezondheid [NFGV]) (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Sophia Foundation for Scientific Research (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/20932360

Publication citations

  1. Results

    van der Leeden AJ, van Widenfelt BM, van der Leeden R, Liber JM, Utens EM, Treffers PD, Stepped care cognitive behavioural therapy for children with anxiety disorders: a new treatment approach., Behav Cogn Psychother, 2011, 39, 1, 55-75, doi: 10.1017/S1352465810000500.

Additional files

Editorial Notes