Virtual Reality Exposure Therapy in Agoraphobic Participants

September 11, 2018 updated by: Paul M.G.Emmelkamp, VU University of Amsterdam

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

55

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Amsterdam, Netherlands
        • University of Amsterdam

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Assessed at pre- and post-treatment and 6-12 months follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VU University of Amsterdam

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

August 11, 2008

First Submitted That Met QC Criteria

August 13, 2008

First Posted (Estimate)

August 14, 2008

Study Record Updates

Last Update Posted (Actual)

September 13, 2018

Last Update Submitted That Met QC Criteria

September 11, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KP-2008-518

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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