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NCT00129610 Clinical Trial

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

Panic Disorder Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT00129610
Other study ID # 2002.307
Secondary ID
Status Active, not recruiting
Phase N/A
First received August 11, 2005
Last updated April 26, 2007
Start date January 2004

Study information
Verified date April 2007
Source Hospices Civils de Lyon
Contact n/a
Is FDA regulated No
Health authority France: Ministry of Health
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 90
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 60 Years
Eligibility 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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Educational/Counseling/Training

Related Conditions & MeSH terms

Intervention

Behavioral:
• Virtual Reality Therapy

• Cognitive Behavior Therapy

Locations
Country Name City State
France Hôpital Pierre Wertheimer Bron

Sponsors (1)
Lead Sponsor Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary The response criterion is a decrease of 50% of the agoraphobia subscore on the Fear Questionnaire
Secondary Pre-test, post-test, 6 months and one year
Secondary Panic Disorder Severity Scale
Secondary Agoraphobic cognitions
Secondary Panic, phobia, generalized anxiety
Secondary Trait State Anxiety Inventory (STAI)
Secondary Hamilton Anxiety Scale
Secondary Dissociative experiences
Secondary Beck Depression Inventory
Secondary Quality of Life, handicap
Secondary Spatial cognition: Rey’s Figure and Rod and Frame test
Secondary Therapeutic expectations (pre-test)
Secondary Therapeutic relationship (post-test)
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