Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00129610
Recruitment Status : Unknown
Verified April 2007 by Hospices Civils de Lyon.
Recruitment status was:  Active, not recruiting
First Posted : August 12, 2005
Last Update Posted : April 27, 2007
Sponsor:
Information provided by:
Hospices Civils de Lyon

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.

Condition or disease Intervention/treatment Phase
Panic Disorder Agoraphobia Behavioral: Virtual Reality Therapy Behavioral: Cognitive Behavior Therapy Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Educational/Counseling/Training
Official Title: A Comparative Controlled Study of Virtual Reality Therapy and Cognitive Behavior Therapy in Panic Disorder With Agoraphobia
Study Start Date : January 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Panic Disorder




Primary Outcome Measures :
  1. The response criterion is a decrease of 50% of the agoraphobia subscore on the Fear Questionnaire

Secondary Outcome Measures :
  1. Pre-test, post-test, 6 months and one year
  2. Panic Disorder Severity Scale
  3. Agoraphobic cognitions
  4. Panic, phobia, generalized anxiety
  5. Trait State Anxiety Inventory (STAI)
  6. Hamilton Anxiety Scale
  7. Dissociative experiences
  8. Beck Depression Inventory
  9. Quality of Life, handicap
  10. Spatial cognition: Rey's Figure and Rod and Frame test
  11. Therapeutic expectations (pre-test)
  12. Therapeutic relationship (post-test)


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00129610


Locations
Layout table for location information
France
Hôpital Pierre Wertheimer
Bron, France, 69677
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
Layout table for investigator information
Principal Investigator: Jean COTTRAUX, MD Hospices Civils de Lyon
Layout table for additonal information
ClinicalTrials.gov Identifier: NCT00129610    
Other Study ID Numbers: 2002.307
First Posted: August 12, 2005    Key Record Dates
Last Update Posted: April 27, 2007
Last Verified: April 2007
Keywords provided by Hospices Civils de Lyon:
Agoraphobia
panic disorder
Virtual Reality Therapy
Cognitive Behavior Therapy
cognition
spatial cognition
PANIC DISORDER WITH AGORAPHOBIA
Additional relevant MeSH terms:
Layout table for MeSH terms
Disease
Panic Disorder
Agoraphobia
Pathologic Processes
Anxiety Disorders
Mental Disorders