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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2007 by Hospices Civils de Lyon.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00129610
First Posted: August 12, 2005
Last Update Posted: April 27, 2007
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.
Information provided by:
Hospices Civils de Lyon
  Purpose
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 Intervention
Panic Disorder Agoraphobia Behavioral: Virtual Reality Therapy Behavioral: Cognitive Behavior Therapy

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Hospices Civils de Lyon:

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)

Estimated Enrollment: 90
Study Start Date: January 2004
  Eligibility

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.


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.
  Contacts and Locations
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
France
Hôpital Pierre Wertheimer
Bron, France, 69677
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
Principal Investigator: Jean COTTRAUX, MD Hospices Civils de Lyon
  More Information

ClinicalTrials.gov Identifier: NCT00129610     History of Changes
Other Study ID Numbers: 2002.307
First Submitted: August 11, 2005
First Posted: August 12, 2005
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:
Disease
Panic Disorder
Agoraphobia
Pathologic Processes
Anxiety Disorders
Mental Disorders