This trial is active, not recruiting.

Conditions panic disorder, agoraphobia
Treatments virtual reality therapy, cognitive behavior therapy
Sponsor Hospices Civils de Lyon
Start date January 2004
Trial size 90 participants
Trial identifier NCT00129610, 2002.307


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose educational/counseling/training

Primary Outcomes

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

Secondary Outcomes

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

Eligibility Criteria

Male or female participants from 18 years up to 60 years old.

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.

Additional Information

Official title A Comparative Controlled Study of Virtual Reality Therapy and Cognitive Behavior Therapy in Panic Disorder With Agoraphobia
Principal investigator Jean COTTRAUX, MD
Trial information was received from ClinicalTrials.gov and was last updated in April 2007.
Information provided to ClinicalTrials.gov by Hospices Civils de Lyon.