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

Study Overview
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Brief Summary
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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.

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

Conditions
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Panic Disorder, Agoraphobia

Intervention / Treatment
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* Behavioral: Virtual Reality Therapy
* Behavioral: Cognitive Behavior Therapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Educational/Counseling/Training
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Virtual Reality Therapy|nan|
|Behavioral: Cognitive Behavior Therapy|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The response criterion is a decrease of 50% of the agoraphobia subscore on the Fear Questionnaire |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Agoraphobia, panic disorder, Virtual Reality Therapy, Cognitive Behavior Therapy, cognition, spatial cognition, PANIC DISORDER WITH AGORAPHOBIA