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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04737915
Other study ID # Interventional
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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)
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