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Virtual Reality Exposure Versus In Vivo Exposure for Fear of Heights

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ClinicalTrials.gov Identifier: NCT04737915
Recruitment Status : Completed
First Posted : February 4, 2021
Last Update Posted : February 8, 2021
Sponsor:
Information provided by (Responsible Party):
Jennifer Hames, University of Notre Dame

Study Description
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Brief Summary:
This study randomly assigned 114 participants with significant fear of heights to one of three conditions: a) a single session of virtual reality exposure; b) a single session of in vivo exposure; or c) a control condition. The aim of this study was to compare the efficacy of virtual reality exposure to the efficacy of in vivo exposure or no exposure for participants with significant fear of heights.

Condition or disease Intervention/treatment Phase
Fear of Heights Acrophobia Specific Phobia Anxiety Disorder Behavioral: Exposure Therapy (In Vivo) Behavioral: Exposure Therapy (Virtual Reality) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 114 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Eligible participants were randomly assigned to one of three conditions: a) single session virtual reality exposure; b) single session in vivo exposure; c) waitlist control
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparing the Efficacy of a Single-Session Virtual Reality Treatment for Fear of Heights to In Vivo Exposure and No Treatment
Actual Study Start Date : June 11, 2018
Actual Primary Completion Date : March 6, 2019
Actual Study Completion Date : March 6, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arms and Interventions
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Arm Intervention/treatment
Experimental: Virtual Reality Exposure
Participants completed a single session of exposure administered via a virtual reality headset. The exposure exercise involved looking over virtual railings into an atrium at various floor levels (the virtual environment was designed to look like the atrium in the in vivo exposure condition). Exposure was conducted in six 6-minute trials for a total of 36 minutes of exposure.
 Behavioral: Exposure Therapy (Virtual Reality)
Participant completes a single session of exposure therapy for fear of heights by looking over railings into an atrium at various floor levels in a real environment.
Experimental: In Vivo Exposure
Participants completed a single session of exposure administered in vivo. The exposure exercise involved looking over actual railings into an atrium at various floor levels. Exposure was conducted in six 6-minute trials for a total of 36 minutes of exposure.
 Behavioral: Exposure Therapy (In Vivo)
Participant completes a single session of exposure therapy for fear of heights by looking over railings into an atrium at various floor levels in a virtual environment.
No Intervention: Waitlist Control
Participants watched a neutral video during the time participants in other conditions were completing the exposure exercise. Participants received no exposure-based intervention.


Outcome Measures
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Primary Outcome Measures :
  1. Acrophobia Questionnaire (AQ) [ Time Frame: Immediately Post-Treatment (Controlling for Baseline Scores) ]
    Participants completed the anxiety subscale of the AQ, a 20-item questionnaire that assesses self-reported anxiety related to acrophobia. Scores for the subscale are summed, and totals range from 0 to 120, with higher scores indicating greater anxiety.

  2. Behavioral Approach Task (BAT) [ Time Frame: Immediately Post-Treatment (Controlling for Baseline Scores) ]
    Participants walked up a staircase until they reach the highest level they can complete, while stopping to look over the ledge toward the floor at each landing. During each BAT, fear response was assessed behaviorally (highest step reached) and subjectively (self reported levels of fear).

  3. Heights Interpretation Questionnaire (HIQ) [ Time Frame: Immediately Post-Treatment (Controlling for Baseline Scores) ]
    Participants completed the HIQ, a 16-item questionnaire that assesses self-reported interpretations of an imagined experience of heights. Items are summed scored, and totals ranged from 16 to 80, with higher scores indicating greater height fear-relevant interpretation bias.

  4. Acrophobia Questionnaire (AQ) [ Time Frame: 1-Week Post-Treatment (Controlling for Immediate Post-Treatment Scores) ]
    Participants completed the anxiety subscale of the AQ, a 20-item questionnaire that assesses self-reported anxiety related to acrophobia. Scores for the subscale are summed, and totals range from 0 to 120, with higher scores indicating greater anxiety.

  5. Behavioral Approach Task (BAT) [ Time Frame: 1-Week Post-Treatment (Controlling for Immediate Post-Treatment Scores) ]
    Participants walked up a staircase until they reach the highest level they can complete, while stopping to look over the ledge toward the floor at each landing. During each BAT, fear response was assessed behaviorally (highest step reached) and subjectively (self reported levels of fear).

  6. Heights Interpretation Questionnaire (HIQ) [ Time Frame: 1-Week Post-Treatment (Controlling for Immediate Post-Treatment Scores) ]
    Participants completed the HIQ, a 16-item questionnaire that assesses self-reported interpretations of an imagined experience of heights. Items are summed scored, and totals ranged from 16 to 80, with higher scores indicating greater height fear-relevant interpretation bias.


Other Outcome Measures:
  1. Anxiety Sensitivity Index (ASI) [ Time Frame: Baseline, Immediately Post-Treatment; 1 Week Post-Treatment ]
    The ASI is a 16 item measure assessing participants' fear of and sensitivity to physiological symptoms of anxiety. Scores range from 0-64, with higher scores indicating higher levels of anxiety sensitivity.

  2. Affective Control Scale (ACS) - Anxiety Subscale [ Time Frame: Baseline, Immediately Post-Treatment; 1 Week Post-Treatment ]
    The 13-item anxiety subscale of the ACS measures participants' fear tolerance. Scores range from 13-91, with higher scores indicating lower levels of anxiety fear tolerance.

  3. High Place Phenomenon Index (HPPI) [ Time Frame: Baseline, Immediately Post-Treatment; 1 Week Post-Treatment ]
    The HPPI is a 3-item measure that assesses participants' self-reported experience of the high place phenomenon. Scores range from 3-21, with higher scores indicating more frequent experience of the high place phenomenon.

  4. Patient Health Questionnaire (PHQ) - 8 item version [ Time Frame: Baseline, Immediately Post-Treatment; 1 Week Post-Treatment ]
    The PHQ is traditionally a 9 item measure, but this study used an 8 item version that did not include item 9 (assessing suicidality). Scores on this version range from 0 to 24, with higher scores indicating higher levels of depressive symptoms.

  5. DSM-5 (Diagnostic and Statistical Manual of Mental Disorders - 5) Severity Measure for Specific Phobia (Adapted for Acrophobia) [ Time Frame: Baseline, Immediately Post-Treatment; 1 Week Post-Treatment ]
    Participants completed the DSM-5 Severity Measure, a 10-item questionnaire that assesses the severity of DSM-5 symptoms of specific phobias. Total scores range from 0 to 40, with higher scores indicating higher levels of specific phobia symptomology.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Score >= 45 on the Acrophobia Questionnaire (AQ)

Exclusion Criteria:

  • Already receiving therapy specifically for fear of heights.
  • Has any contraindications to using a virtual reality headset.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04737915


Locations
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United States, Indiana
University of Notre Dame
Notre Dame, Indiana, United States, 46556
Sponsors and Collaborators
University of Notre Dame
Investigators
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Principal Investigator: Jennifer L Hames, Ph.D. University of Notre Dame
More Information
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Responsible Party: Jennifer Hames, Assistant Clinical Professor & Clinic Director, University of Notre Dame
ClinicalTrials.gov Identifier: NCT04737915    
Other Study ID Numbers: Interventional
First Posted: February 4, 2021    Key Record Dates
Last Update Posted: February 8, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Study protocols and de-identified data will be shared at the request of other researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Anxiety Disorders
Mental Disorders