NCT00129610

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.

Trial Health

55
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

August 11, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 12, 2005

Completed
Last Updated

April 27, 2007

Status Verified

April 1, 2007

First QC Date

August 11, 2005

Last Update Submit

April 26, 2007

Conditions

Panic DisorderAgoraphobia

Keywords

Agoraphobiapanic disorderVirtual Reality TherapyCognitive Behavior Therapycognitionspatial cognitionPANIC DISORDER WITH AGORAPHOBIA

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (12)

  • Pre-test, post-test, 6 months and one year

  • Panic Disorder Severity Scale

  • Agoraphobic cognitions

  • Panic, phobia, generalized anxiety

  • Trait State Anxiety Inventory (STAI)

  • +7 more secondary outcomes

Interventions

Virtual Reality TherapyBEHAVIORAL
Cognitive Behavior TherapyBEHAVIORAL

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Pierre Wertheimer

Bron, 69677, France

Location

MeSH Terms

Conditions

Panic DisorderAgoraphobia

Interventions

Virtual Reality Exposure TherapyCognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Anxiety DisordersMental DisordersPhobic Disorders

Intervention Hierarchy (Ancestors)

Desensitization, PsychologicBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Jean COTTRAUX, MD

    Hospices Civils de Lyon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
ECT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 11, 2005

First Posted

August 12, 2005

Study Start

January 1, 2004

Last Updated

April 27, 2007

Record last verified: 2007-04

Locations

FR(1)