Virtual Reality Exposure Versus In Vivo Exposure for Fear of Heights

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Exposure Therapy (In Vivo)

Exposure Therapy (Virtual Reality)

About this trial

This is an interventional treatment trial for Fear of Heights

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

University of Notre Dame

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

Arm Label

Virtual Reality Exposure

In Vivo Exposure

Waitlist Control

Arm Description

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.

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.

Participants watched a neutral video during the time participants in other conditions were completing the exposure exercise. Participants received no exposure-based intervention.

Outcomes

Primary Outcome Measures

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.

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).

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.

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.

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).

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT04737915

First Posted

January 28, 2021

Last Updated

February 3, 2021

Sponsor

University of Notre Dame

1. Study Identification

Unique Protocol Identification Number

NCT04737915

Brief Title

Virtual Reality Exposure Versus In Vivo Exposure for Fear of Heights

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2021

Overall Recruitment Status

Completed

Study Start Date

June 11, 2018 (Actual)

Primary Completion Date

March 6, 2019 (Actual)

Study Completion Date

March 6, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Notre Dame

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Fear of Heights, Acrophobia, Specific Phobia, Anxiety Disorder

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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)

Allocation

Randomized

Enrollment

114 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Virtual Reality Exposure

Arm Type

Experimental

Arm Description

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.

Arm Title

In Vivo Exposure

Arm Type

Experimental

Arm Description

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.

Arm Title

Waitlist Control

Arm Type

No Intervention

Arm Description

Participants watched a neutral video during the time participants in other conditions were completing the exposure exercise. Participants received no exposure-based intervention.

Intervention Type

Behavioral

Intervention Name(s)

Exposure Therapy (In Vivo)

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Exposure Therapy (Virtual Reality)

Intervention Description

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.

Primary Outcome Measure Information:

Title

Acrophobia Questionnaire (AQ)

Description

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.

Time Frame

Immediately Post-Treatment (Controlling for Baseline Scores)

Title

Behavioral Approach Task (BAT)

Description

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).

Time Frame

Immediately Post-Treatment (Controlling for Baseline Scores)

Title

Heights Interpretation Questionnaire (HIQ)

Description

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.

Time Frame

Immediately Post-Treatment (Controlling for Baseline Scores)

Title

Acrophobia Questionnaire (AQ)

Description

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.

Time Frame

1-Week Post-Treatment (Controlling for Immediate Post-Treatment Scores)

Title

Behavioral Approach Task (BAT)

Description

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).

Time Frame

1-Week Post-Treatment (Controlling for Immediate Post-Treatment Scores)

Title

Heights Interpretation Questionnaire (HIQ)

Description

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.

Time Frame

1-Week Post-Treatment (Controlling for Immediate Post-Treatment Scores)

Other Pre-specified Outcome Measures:

Title

Anxiety Sensitivity Index (ASI)

Description

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.

Time Frame