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

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

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

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.

Detailed Summary:
Sponsor: Hospices Civils de Lyon

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

Original Primary Outcome: The response criterion is a decrease of 50 % of the agroraphobia subscore on the Fear Questionnaire

Current Secondary Outcome:

  • 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)


Original Secondary Outcome:

  • Pre-test, post-test, 6 months and one year
  • Panic Disorder Severtit Scale, Agoraphobic cognitions, Panic, phobia, generalized anxiety, Trait State Anxiety (STAI), Hamilton-Anxiety, Dissociative experiences, Beck Depression Inventory, Quality of Life, handicap
  • Spatial cognition : Rey’s figure, rod and frame test
  • Therapeutic expectations (pre-test)
  • Therapeutic relationship (post-test)


Information By: Hospices Civils de Lyon

Dates:
Date Received: August 11, 2005
Date Started: January 2004
Date Completion:
Last Updated: April 26, 2007
Last Verified: April 2007