Virtual Reality Exposure Versus In Vivo Exposure for Fear of Heights

Comparing the Efficacy of a Single-Session Virtual Reality Treatment for Fear of Heights to In Vivo Exposure and No Treatment

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.

Study Overview

• Status: Completed
• Conditions: Specific Phobia; Anxiety Disorder; Fear of Heights; Acrophobia
• Intervention / Treatment: Behavioral: Exposure Therapy (Virtual Reality); Behavioral: Exposure Therapy (In Vivo)

• Study Type: Interventional
• Enrollment (Actual): 114
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Notre Dame, Indiana, United States, 46556
      • University of Notre Dame

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acrophobia Questionnaire (AQ)	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.	Immediately Post-Treatment (Controlling for Baseline Scores)
Behavioral Approach Task (BAT)	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).	Immediately Post-Treatment (Controlling for Baseline Scores)
Heights Interpretation Questionnaire (HIQ)	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.	Immediately Post-Treatment (Controlling for Baseline Scores)
Acrophobia Questionnaire (AQ)	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.	1-Week Post-Treatment (Controlling for Immediate Post-Treatment Scores)
Behavioral Approach Task (BAT)	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).	1-Week Post-Treatment (Controlling for Immediate Post-Treatment Scores)
Heights Interpretation Questionnaire (HIQ)	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.	1-Week Post-Treatment (Controlling for Immediate Post-Treatment Scores)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety Sensitivity Index (ASI)	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.	Baseline, Immediately Post-Treatment; 1 Week Post-Treatment
Affective Control Scale (ACS) - Anxiety Subscale	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.	Baseline, Immediately Post-Treatment; 1 Week Post-Treatment
High Place Phenomenon Index (HPPI)	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.	Baseline, Immediately Post-Treatment; 1 Week Post-Treatment
Patient Health Questionnaire (PHQ) - 8 item version	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.	Baseline, Immediately Post-Treatment; 1 Week Post-Treatment
DSM-5 (Diagnostic and Statistical Manual of Mental Disorders - 5) Severity Measure for Specific Phobia (Adapted for Acrophobia)	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.	Baseline, Immediately Post-Treatment; 1 Week Post-Treatment

Collaborators and Investigators

• Sponsor: University of Notre Dame
• Investigators: Principal Investigator: Jennifer L Hames, Ph.D., University of Notre Dame

Study record dates

Study Major Dates

• Study Start (Actual): June 11, 2018
• Primary Completion (Actual): March 6, 2019
• Study Completion (Actual): March 6, 2019

Study Registration Dates

• First Submitted: January 28, 2021
• First Submitted That Met QC Criteria: February 2, 2021
• First Posted (Actual): February 4, 2021

Study Record Updates

• Last Update Posted (Actual): February 8, 2021
• Last Update Submitted That Met QC Criteria: February 3, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: Interventional (Oncolys BioPharma Inc)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Study protocols and de-identified data will be shared at the request of other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No