Effectiveness of CBT for Anxiety Disorders in Western Norway - Full Text View

Sponsor:	Haukeland University Hospital
Collaborator:	University of Bergen
Information provided by:	Haukeland University Hospital
ClinicalTrials.gov Identifier:	NCT00586586

Purpose

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.

Condition	Intervention	Phase
Separation Anxiety Disorder Social Anxiety Disorder Generalized Anxiety Disorder	Behavioral: Cognitive behavioural therapy	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Efficacy Study
Official Title:	An Effectiveness Study of the FRIENDS Program for Anxiety Disorders in Western Norway Child and Adolescent Mental Health Services

Resource links provided by NLM:

MedlinePlus related topics: Anxiety Child Mental Health Mental Health

U.S. FDA Resources

Further study details as provided by Haukeland University Hospital:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	200
Study Start Date:	January 2008
Estimated Study Completion Date:	December 2017
Estimated Primary Completion Date:	December 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental Group CBT	Behavioral: Cognitive behavioural therapy The FRIENDS program developed by Paula Barrett, 10 weekly sessions of 60-90 minutes, with two additional parent meetings, and booster sessions 4 and 12 weeks after treatment.
B: Experimental Individual CBT	Behavioral: Cognitive behavioural therapy The FRIENDS program developed by Paula Barrett, 10 weekly sessions of 60-90 minutes, with two additional parent meetings, and booster sessions 4 and 12 weeks after treatment.
C: No Intervention Waiting-list control	Behavioral: Cognitive behavioural therapy The FRIENDS program developed by Paula Barrett, 10 weekly sessions of 60-90 minutes, with two additional parent meetings, and booster sessions 4 and 12 weeks after treatment.

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.

Eligibility

Ages Eligible for Study:	8 Years to 15 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00586586

Contacts

Contact: Einar Heiervang, MD

+4799568583

einar.heiervang@rbup.uib.no

Locations

Norway
Haukeland University Hospital	Recruiting
Bergen, Norway, 5021

Sponsors and Collaborators

Haukeland University Hospital

University of Bergen

Investigators

Principal Investigator:

Einar Heiervang, MD

Haukeland University Hospital

More Information

No publications provided

Responsible Party:	Haukeland University Hospital ( Einar Heiervang MD )
Study ID Numbers:	17563
Study First Received:	December 21, 2007
Last Updated:	December 15, 2008
ClinicalTrials.gov Identifier:	NCT00586586 History of Changes
Health Authority:	Norway: Norwegian Social Science Data Services

Additional relevant MeSH terms:

Pathologic Processes
Disease
Anxiety Disorders
Mental Disorders

Mental Disorders Diagnosed in Childhood
Anxiety, Separation
Phobic Disorders

ClinicalTrials.gov processed this record on November 09, 2009