Back to resultsStudy of Virtual Reality Therapy and Cognitive Behavior Therapy in Panic Disorder With Agoraphobia
Primary Purpose
Panic Disorder, Agoraphobia
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Virtual Reality Therapy
Cognitive Behavior Therapy
Sponsored by
About this trial
This is an interventional educational/counseling/training trial for Panic Disorder focused on measuring Agoraphobia, panic disorder, Virtual Reality Therapy, Cognitive Behavior Therapy, cognition, spatial cognition, PANIC DISORDER WITH AGORAPHOBIA
Eligibility Criteria
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.
Sites / Locations
- Hôpital Pierre Wertheimer
Outcomes
Primary Outcome Measures
The response criterion is a decrease of 50% of the agoraphobia subscore on the Fear Questionnaire
Secondary Outcome Measures
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)
Full Information
NCT ID
NCT00129610
First Posted
August 11, 2005
Last Updated
April 26, 2007
Sponsor
Hospices Civils de Lyon
1. Study Identification
Unique Protocol Identification Number
NCT00129610
Brief Title
Study of Virtual Reality Therapy and Cognitive Behavior Therapy in Panic Disorder With Agoraphobia
Official Title
A Comparative Controlled Study of Virtual Reality Therapy and Cognitive Behavior Therapy in Panic Disorder With Agoraphobia
Study Type
Interventional
2. Study Status
Record Verification Date
April 2007
Overall Recruitment Status
Unknown status
Study Start Date
January 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Hospices Civils de Lyon
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Panic Disorder, Agoraphobia
Keywords
Agoraphobia, panic disorder, Virtual Reality Therapy, Cognitive Behavior Therapy, cognition, spatial cognition, PANIC DISORDER WITH AGORAPHOBIA
7. Study Design
Primary Purpose
Educational/Counseling/Training
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (false)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Virtual Reality Therapy
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavior Therapy
Primary Outcome Measure Information:
Title
The response criterion is a decrease of 50% of the agoraphobia subscore on the Fear Questionnaire
Secondary Outcome Measure Information:
Title
Pre-test, post-test, 6 months and one year
Title
Panic Disorder Severity Scale
Title
Agoraphobic cognitions
Title
Panic, phobia, generalized anxiety
Title
Trait State Anxiety Inventory (STAI)
Title
Hamilton Anxiety Scale
Title
Dissociative experiences
Title
Beck Depression Inventory
Title
Quality of Life, handicap
Title
Spatial cognition: Rey's Figure and Rod and Frame test
Title
Therapeutic expectations (pre-test)
Title
Therapeutic relationship (post-test)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean COTTRAUX, MD
Organizational Affiliation
Hospices Civils de Lyon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Pierre Wertheimer
City
Bron
ZIP/Postal Code
69677
Country
France
12. IPD Sharing Statement
Learn more about this trial
Study of Virtual Reality Therapy and Cognitive Behavior Therapy in Panic Disorder With Agoraphobia
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