Study of Virtual Reality Therapy and Cognitive Behavior Therapy in Panic Disorder With Agoraphobia - Full Text View

Purpose

The study aims at comparing virtual reality therapy (VRT) with a usual cognitive behavior therapy (CBT) program for agoraphobia. A waiting list represents the control condition. The investigators' purpose is to test a pure VRT compared with a pure CBT, as previous works suggest that the combination of the two methods are clinically effective. Patients receive a two-page information leaflet about the trial and sign an informed consent. After the first evaluation, they are randomized, in three centers (Lyon, Paris, Luxemburg), either to VRT (12 sessions) or CBT (12 sessions), or a waiting-list control condition for three months. After three months the waiting list is randomized to VRT or CBT. The follow-up is one year from entry into the active part of the trial.

Condition	Intervention
Panic Disorder Agoraphobia	Behavioral: Virtual Reality Therapy Behavioral: Cognitive Behavior Therapy

MedlinePlus related topics:

Anxiety Panic Disorder

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Educational/Counseling/Training, Randomized, Open Label, Active Control, Parallel Assignment

Official Title:	A Comparative Controlled Study of Virtual Reality Therapy and Cognitive Behavior Therapy in Panic Disorder With Agoraphobia

Further study details as provided by Hospices Civils de Lyon:

Primary Outcome Measures:

The response criterion is a decrease of 50% of the agoraphobia subscore on the Fear Questionnaire

Secondary Outcome Measures:

Pre-test, post-test, 6 months and one year
Panic Disorder Severity Scale
Agoraphobic cognitions
Panic, phobia, generalized anxiety
Trait State Anxiety Inventory (STAI)
Hamilton Anxiety Scale
Dissociative experiences
Beck Depression Inventory
Quality of Life, handicap
Spatial cognition: Rey’s Figure and Rod and Frame test
Therapeutic expectations (pre-test)
Therapeutic relationship (post-test)

Estimated Enrollment:	90
Study Start Date:	January 2004

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

The study includes 90 patients, aged from 18 to 60, with DSM-4 panic disorder with agoraphobia.
Patients should not be clinically depressed and present a Hamilton Scale of Depression score of less than 18.

Exclusion Criteria:

Patients with active medication (antidepressants, neuroleptics, mood stabilizers, benzodiazepines, Kava Kava, or hypericum) or street drugs. Minor herbal medicine is tolerated.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00129610

Locations


France
	Hôpital Pierre Wertheimer
	BRON, France, 69677

Sponsors and Collaborators

Hospices Civils de Lyon

Investigators


Principal Investigator:	Jean COTTRAUX, MD	Hospices Civils de Lyon

More Information

Study ID Numbers:	2002.307
First Received:	August 11, 2005
Last Updated:	April 26, 2007
ClinicalTrials.gov Identifier:	NCT00129610
Health Authority:	France: Ministry of Health

Keywords provided by Hospices Civils de Lyon:

Agoraphobia

panic disorder

Virtual Reality Therapy

Cognitive Behavior Therapy

cognition

spatial cognition

PANIC DISORDER WITH AGORAPHOBIA

Study placed in the following topic categories:

Panic Disorder

Anxiety Disorders

Mental Disorders

Agoraphobia

Additional relevant MeSH terms:

Pathologic Processes

Disease

ClinicalTrials.gov processed this record on September 23, 2008

Sponsored by:	Hospices Civils de Lyon
Information provided by:	Hospices Civils de Lyon
ClinicalTrials.gov Identifier:	NCT00129610