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

Hospices Civils de Lyon90 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

ECT

Masking

NONE

Enrollment

Conditions

Panic Disorder Agoraphobia

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

Secondary Outcomes

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)