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Cognitive behavioral treatment of children and adolescents with anxiety disorders: optimizing treatment based on patient characteristics.


- candidate number1608
- NTR NumberNTR347
- ISRCTNISRCTN48511871
- Date ISRCTN created20-dec-2005
- date ISRCTN requested18-okt-2005
- Date Registered NTR13-sep-2005
- Secondary IDs5484 (NFGV) 
- Public TitleCognitive behavioral treatment of children and adolescents with anxiety disorders: optimizing treatment based on patient characteristics.
- Scientific TitleCognitive behavioral treatment of children and adolescents with anxiety disorders.
- ACRONYMN/A
- hypothesis1. Group cognitive behavioral treatment is as effective as individual cognitive behavioral 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.
- Healt Condition(s) or Problem(s) studiedAnxiety disorders
- Inclusion criteriaChildren and adolescents between 8 and 16 years old, primary diagnosed with at least one of following DSM IV anxiety disorders: separation anxiety disorder, social phobia, generalized anxiety disorder or specific phobia.
- Exclusion criteria1. 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. Schizofrenia 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.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-sep-2002
- planned closingdate1-dec-2006
- Target number of participants180
- InterventionsIndividual cognitive behavioral treatment or Group cognitive behavioral treatment.
- Primary outcome1. Diagnostic status;
2. Anxiety symptoms.
- Secondary outcome1. Depressive symptoms;
2. Other symptoms of psychopathology;
3. Global level of functioning.
- TimepointsN/A
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIES Adelinde J.M. Leeden, van der
- CONTACT for SCIENTIFIC QUERIESMD. PhD. P.D.A. Treffers
- Sponsor/Initiator Leiden University Medical Center (LUMC), Erasmus Medical Center
- Funding
(Source(s) of Monetary or Material Support)
NFGV National Fund public mental health (Nationaal Fonds Geestelijke Volksgezondheid), Revolving Fund Leiden University Medical Center , Sophia Foundation for Scientific Research
- PublicationsN/A
- Brief summaryAnxiety disorders in children and adolescents are common. Cognitive behavioral treatment is effective for most children with anxiety disorders, but some children do not benefit enough and remain anxious. The present study examined the efficacy of individual versus group cognitive behavioral therapy. The present study also examines which factors predict treatment outcome. Participants are children and adolescents from 8 to 16 years old diagnosed with anxiety disorder(s), assessed by the Anxiety Disorders Interview Schedule (ADIS). Children and parents completed self-report measures assessing overall functioning, presence of psychiatric symptoms, anxiety symptoms, depression symptoms, social skills, negative affectivity, anxiety sensitivity and parental rearing practices. Physiological measures are conducted measuring heart rate, breathing, skin conduction, blood pressure and Cortisol concentration in saliva. Genetic factors are also examined, as is attention bias using a probe detection task.
- Main changes (audit trail)
- RECORD13-sep-2005 - 14-sep-2009


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