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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00071630
Registration number
NCT00071630
Ethics application status
Date submitted
29/10/2003
Date registered
30/10/2003
Date last updated
7/11/2013
Titles & IDs
Public title
Therapeutic Processes and Treatment Outcome in Adolescents With Anxiety Disorders
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Scientific title
Process as a Predictor of Outcomes in CBT for Youth
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Secondary ID [1]
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R01MH064484
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Secondary ID [2]
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R01MH064484
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Anxiety Disorders
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Condition category
Condition code
Mental Health
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Anxiety
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
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Comparator / control treatment
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Control group
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Outcomes
Eligibility
Key inclusion criteria
Inclusion criteria:
* Diagnosis of separation anxiety disorder, generalized anxiety disorder, or social phobia
* At least one English-speaking parent
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Minimum age
8
Years
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Maximum age
13
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Exclusion criteria:
* IQ < 80
* Psychotic symptoms
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 4
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/09/2002
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Macquarie University - Sydney
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Recruitment postcode(s) [1]
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2109 - Sydney
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Pennsylvania
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Funding & Sponsors
Primary sponsor type
Other
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Name
Temple University
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Address
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Country
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Other collaborator category [1]
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Government body
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Name [1]
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National Institute of Mental Health (NIMH)
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to examine the relationship between different aspects of cognitive behavior therapy (CBT) and treatment outcome.
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Trial website
https://clinicaltrials.gov/study/NCT00071630
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT00071630
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