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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
  Purpose

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.

Condition Intervention Phase
Panic Disorder
Agoraphobia
Behavioral: Virtual Reality Exposure Therapy for agoraphobic participants
Behavioral: Standard exposure in vivo for agoraphobic participants
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Virtual Reality Exposure Therapy in Agoraphobic Participants

Resource links provided by NLM:


Further study details as provided by VU University of Amsterdam:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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.


Enrollment: 55
Study Start Date: October 2008
Study Completion Date: January 2012
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: VRET
Virtual Reality Exposure Therapy for agoraphobic participants
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
Active Comparator: Exposure in vivo
Standard exposure in vivo for panic disorder
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)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00734370

Locations
Netherlands
University of Amsterdam
Amsterdam, Netherlands
Sponsors and Collaborators
VU University of Amsterdam
Investigators
Principal Investigator: Paul MG Emmelkamp, Professor University of Amsterdam, The Netherlands
  More Information

No publications provided

Responsible Party: Paul M.G.Emmelkamp, Professor, VU University of Amsterdam
ClinicalTrials.gov Identifier: NCT00734370     History of Changes
Other Study ID Numbers: KP-2008-518
Study First Received: August 11, 2008
Last Updated: March 20, 2013
Health Authority: Netherlands: Independent Ethics Committee

Keywords provided by VU University of Amsterdam:
Panic Disorder and Agoraphobia
Virtual Reality Exposure Therapy

Additional relevant MeSH terms:
Agoraphobia
Panic Disorder
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on November 23, 2014