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Virtual Reality Exposure Therapy in Agoraphobic Participants

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Paul M.G.Emmelkamp, VU University of Amsterdam
ClinicalTrials.gov Identifier:
NCT00734370
First received: August 11, 2008
Last updated: March 20, 2013
Last verified: March 2013

August 11, 2008
March 20, 2013
October 2008
June 2011   (final data collection date for primary outcome measure)
Panic Disorder Severity Scale (PDSS); Mobility Inventory for Agoraphobia (MI); Behavioural Avoidance Test (BAT) [ Time Frame: Assessed at pre- and post-treatment and 6-12 months follow-up ] [ Designated as safety issue: No ]
Panic Disorder Severity Scale (PDSS); Mobility Inventory for Agoraphobia (MI) [ Time Frame: Assessed at pre- and post-treatment and 9-12 months follow-up ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00734370 on ClinicalTrials.gov Archive Site
Beck Anxiety Inventory (BAI); Anxiety Sensitivity Inventory (ASI); Beck Depression Inventory (BDI); Panic Disorder Severity Scale (PDSS); Agoraphobic Cognitions Questionnaire (ACQ); Bodily Sensations Questionnaire (BSQ); Panic Appraisal Inventory (PAI) [ Time Frame: Process measures: are taken prior to treatment, after the fourth treatment session and at post-treatment. The PDSS and PAI will be administered every therapy session ] [ Designated as safety issue: No ]
Process measures are taken prior to treatment, after the fourth treatment session and at post-treatment. The same measures will also be taken at 6 months follow-up.
Beck Anxiety Inventory (BAI); Anxiety Sensitivity Inventory (ASI); Panic Appraisal Inventory (PAI); Beck Depression Inventory (BDI) [ Time Frame: Process measures ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Virtual Reality Exposure Therapy in Agoraphobic Participants
Virtual Reality Exposure Therapy in Agoraphobic Participants

Virtual Reality Exposure Therapy (VRET) is an effective treatment for anxiety disorders, particularly for specific phobias as fear of heights and fear of flying (e.g. Powers & Emmelkamp, 2008). Recent technological advances (e.g. more realistic avatars) make research into the efficacy of VRET for participants with elevated agoraphobic symptoms desirable. Therefore, the aim of the present research proposal is to investigate the comparative efficacy of:

  1. enhanced VRET making use of the latest avatar technology with
  2. exposure in vivo in agoraphobic participants
  3. wait-list control.
Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Panic Disorder
  • Agoraphobia
  • Behavioral: Virtual Reality Exposure Therapy for agoraphobic participants

    This intervention is comprised of 10 sessions of cognitive behavior therapy for panic disorder and agoraphobia with components of

    • Psycho-education, breathing training and cognitive restructuring
    • Virtual reality Exposure to agoraphobic situations and interoceptive exposure
    • Relapse prevention
  • Behavioral: Standard exposure in vivo for agoraphobic participants

    This intervention is comprised of 10 sessions of cognitive behavior therapy for panic disorder and agoraphobia with components of

    • Psycho-education, breathing training and cognitive restructuring
    • Standard exposure in vivo to agoraphobic situations and interoceptive exposure
    • Relapse prevention (according to the protocol of Craske & Barlow)
  • Experimental: VRET
    Virtual Reality Exposure Therapy for agoraphobic participants
    Intervention: Behavioral: Virtual Reality Exposure Therapy for agoraphobic participants
  • Active Comparator: Exposure in vivo
    Standard exposure in vivo for panic disorder
    Intervention: Behavioral: Standard exposure in vivo for agoraphobic participants
  • No Intervention: Wait-list control
    Wait-list control group. Participants from this arm are randomized to the two active conditions after 10 weeks of waiting.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
55
January 2012
June 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • A full diagnosis of panic disorder with agoraphobia according to the DSM-IV
  • Between the ages of 18-65 years
  • Sufficient fluency in Dutch to complete treatment and research protocol

Exclusion Criteria:

  • Presence of medical condition, assessed by self-report questionnaires at the intake (i.e., pregnancy, seizure disorder, pacemaker)
  • Current use of Beta-blockers
  • Current use of tranquilizers (Benzodiazepines)
  • Unstable psychotropic medication
  • Substance dependence
  • Psychosis
  • Depression with suicidal ideation
  • Posttraumatic Stress Disorder
  • Dementia or other severe cognitive impairment
  • Bipolar Disorder
  • Borderline Personality Disorder
  • Anti-social Personality Disorder
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT00734370
KP-2008-518
No
Paul M.G.Emmelkamp, VU University of Amsterdam
VU University of Amsterdam
Not Provided
Principal Investigator: Paul MG Emmelkamp, Professor University of Amsterdam, The Netherlands
VU University of Amsterdam
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP