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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 because the information has not been verified recently.
Verified April 2007 by Hospices Civils de Lyon.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT00129610
First received: August 11, 2005
Last updated: April 26, 2007
Last verified: April 2007
History of Changes
  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: 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:

U.S. FDA Resources

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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00129610     History of Changes
Other Study ID Numbers: 2002.307
Study First Received: August 11, 2005
Last Updated: April 26, 2007
Health Authority: France: Ministry of Health

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:
Agoraphobia
Panic Disorder
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 23, 2013