Virtual Reality Exposure Versus In Vivo Exposure for Fear of Heights

Anxiety Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04737915
• Other study ID #: Interventional
• Status: Completed
• Phase: N/A
• Start date: June 11, 2018
• Est. completion date: March 6, 2019

Study information

• Verified date: February 2021
• Source: University of Notre Dame
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: March 6, 2019
• Est. primary completion date: March 6, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acrophobia
• Anxiety Disorder
• Anxiety Disorders
• Fear of Heights
• Specific Phobia

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Notre Dame	Notre Dame	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
University of Notre Dame

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Other	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
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)