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

NCT ID: NCT00129610

Last Updated: 2007-04-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-01-31

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.

Detailed Description

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Conditions

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Panic Disorder Agoraphobia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

ECT

Blinding Strategy

NONE

Interventions

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Virtual Reality Therapy

Intervention Type BEHAVIORAL

Cognitive Behavior Therapy

Intervention Type BEHAVIORAL

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Principal Investigators

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Jean COTTRAUX, MD

Role: PRINCIPAL_INVESTIGATOR

Hospices Civils de Lyon

Locations

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Hôpital Pierre Wertheimer

Bron, , France

Site Status

Countries

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France

Other Identifiers

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2002.307

Identifier Type: -

Identifier Source: org_study_id