Effectiveness of CBT for Anxiety Disorders in Western Norway - Tabular View

Tracking Information

First Received Date ^ICMJE

December 21, 2007

Last Updated Date

December 15, 2008

Start Date ^ICMJE

January 2008

Estimated Primary Completion Date

December 2015 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Clinical Severity Rating for main inclusion anxiety disorders according to the ADIS interview with parents and youths. [ Time Frame: Post-treatment and 1 and 5 year follow-up ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00586586 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Symptom score on the Spence Children Anxiety Scale [ Time Frame: Post-treatment, 1 and 5 year follow-up ] [ Designated as safety issue: No ]
Diagnostic status according to ADIS interview for inclusion anxiety disorder [ Time Frame: Post-treatment, 1 and 5 year follow-up ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Effectiveness of CBT for Anxiety Disorders in Western Norway

Official Title ^ICMJE

An Effectiveness Study of the FRIENDS Program for Anxiety Disorders in Western Norway Child and Adolescent Mental Health Services

Brief Summary

The study aims to evaluate the effectiveness of a cognitive behaviour therapy program (FRIENDS) for anxiety disorders in children aged 8-15 years who have been referred to child and adolescent mental health clinics in Western Norway.

Detailed Description

Cognitive behaviour therapy (CBT) has been shown to be an effective treatment of anxiety in youths whne delivered in university settings. However, there is a lack of studies evaluating the effctiveness of CBT in regular clinical settings.

The current study will compare a CBT program especially developed for youths (the FRIENDS program by Paula Barrett, Australia), with a waiting-list control condition. Group and individual treatment will also be compared in the study. Groups will be divided by age, with younger including 8-12-year-olds, and older 12-15-year-olds. Parents are also involved at the end of therapy sessions, as well as in separate parent sessions. Therapists are recruited from the clinics.

There are 10 therapy sessions, with booster sessions 4 and 12 weeks later. Treatment effect will be evaluated at post-treatment, and at 1 and 5 years follow-up. The study will have a randomized design. Children randomized to waiting-list will be offered treatment if still meeting criteria for diagnoses when evaluated following the waiting period.

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Efficacy Study

Condition ^ICMJE

Separation Anxiety Disorder
Social Anxiety Disorder
Generalized Anxiety Disorder

Intervention ^ICMJE

Behavioral: Cognitive behavioural therapy

Study Arms / Comparison Groups

Experimental: Group CBT
Experimental: Individual CBT
No Intervention: Waiting-list control

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

200

Estimated Completion Date

December 2017

Estimated Primary Completion Date

December 2015 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Meeting DSM-IV criteria for separation anxiety, social anxiety or generalized anxiety disorder based on the ADIS interview schedule

Exclusion Criteria:

Pervasive developmental disorders, Selective mutism, Mental retardation
Having severe obsessional/compulsive, conduct or language problems.

Gender

Both

Ages

8 Years to 15 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Einar Heiervang, MD

+4799568583

einar.heiervang@rbup.uib.no

Location Countries ^ICMJE

Norway

Administrative Information

NCT ID ^ICMJE

NCT00586586

Responsible Party

Einar Heiervang MD, Haukeland University Hospital

Study ID Numbers ^ICMJE

17563

Study Sponsor ^ICMJE

Haukeland University Hospital

Collaborators ^ICMJE

University of Bergen

Investigators ^ICMJE

Principal Investigator:

Einar Heiervang, MD

Haukeland University Hospital

Information Provided By

Haukeland University Hospital

Verification Date

December 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP