Study of Virtual Reality Therapy and Cognitive Behavior Therapy in Panic Disorder With Agoraphobia

Not Applicable

• Conditions: Panic Disorder; Agoraphobia

• Registration Number: NCT00129610
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-01
• Study First Submitted: 2005-08-11
• Study First Submitted QC: 2005-08-11
• Study First Posted: 2005-08-12
• Status Verified: 2007-04
• Last Update Submitted: 2007-04-26
• Last Update Posted: 2007-04-27

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Hôpital Pierre Wertheimer; 🇫🇷 Bron, France