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
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
-
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.