Treatment of Social Phobia and Panic Disorder in Adults - Full Text View

Sponsored by:	Haukeland University Hospital
Information provided by:	Haukeland University Hospital
ClinicalTrials.gov Identifier:	NCT00619138

Purpose

The purpose of this study is to compare a stepped care model for the treatment of social phobia and panic disorder with standard psychological treatment.

The stepped care model comprises three steps: short psycho-education, a 10 weeks Internet-based self-help program, 12 weeks individual cognitive-behavioural therapy. Patients are assessed at each step and taken out of the study if they show significant clinical improvement and follow for 12 months. Patients are randomized to either the stepped care model or standard psychological treatment, i.e. individual cognitive-behavioural therapy.

All treatment components are manualized.

Condition	Intervention	Phase
Social Phobia Panic Disorder	Behavioral: individual cognitive-behavioural therapy Behavioral: stepped care model	Phase III

MedlinePlus related topics: Anxiety Panic Disorder Phobias

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment
Official Title:	A Randomized, Controlled Study of a Stepped-Care Model for the Treatment of Social Phobia and Panic Disorder in Adults

Further study details as provided by Haukeland University Hospital:

Primary Outcome Measures:

Clinical Severity Ratings [ Time Frame: End of treatment and 12 months follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Questionnaires: The Panic Attack Scale The Body Sensations Questionnaire The Agoraphobic Cognitions Questionnaire The Mobility Inventory for Agoraphobia Social Phobia Scale The Social Interaction Anxiety Scale [ Time Frame: End of treatment and 12 months follow-up ] [ Designated as safety issue: No ]

Estimated Enrollment:	250
Study Start Date:	March 2008
Estimated Study Completion Date:	March 2011
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator	Behavioral: individual cognitive-behavioural therapy 1 session per week for 12 weeks
2: Active Comparator	Behavioral: stepped care model three steps: short psycho-education, a 10 weeks Internet-based self-help program, 12 weeks individual cognitive-behavioural therapy

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Clinical diagnoses of panic disorder or social phobia
Informed consent

Exclusion Criteria:

Alcohol/drug dependency
Major depressive disorder
Psychosis
Unstable medication

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00619138

Contacts

Contact: odd e havik, PhD

+47 55589179

odd.havik@psykp.uib.no

Locations

Norway
haukelandUH	Recruiting
Bergen, Norway
Principal Investigator: odd e havik, PhD

Sponsors and Collaborators

Haukeland University Hospital

Investigators

Principal Investigator:

odd e havik, PhD

University of Bergen

More Information

No publications provided

Responsible Party:	Haukeland University Hospital ( odd e havik professor )
Study ID Numbers:	17650
Study First Received:	January 16, 2008
Last Updated:	January 30, 2009
ClinicalTrials.gov Identifier:	NCT00619138 History of Changes
Health Authority:	Norway: Norwegian Social Science Data Services

Keywords provided by Haukeland University Hospital:

Cognitive therapy
Stepped care
Self-help
Internet
Anxiety

Study placed in the following topic categories:

Panic Disorder
Anxiety Disorders
Mental Disorders
Phobic Disorders

Additional relevant MeSH terms:

Panic Disorder
Pathologic Processes
Disease

Anxiety Disorders
Mental Disorders
Phobic Disorders

ClinicalTrials.gov processed this record on May 07, 2009