NCT04737915

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
114

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 11, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 6, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 6, 2019

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

January 28, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 4, 2021

Completed
Last Updated

February 8, 2021

Status Verified

February 1, 2021

Enrollment Period

9 months

First QC Date

January 28, 2021

Last Update Submit

February 3, 2021

Conditions

Outcome Measures

Primary Outcomes (6)

  • 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 Outcomes (5)

  • Anxiety Sensitivity Index (ASI)

    Baseline, Immediately Post-Treatment; 1 Week Post-Treatment

  • Affective Control Scale (ACS) - Anxiety Subscale

    Baseline, Immediately Post-Treatment; 1 Week Post-Treatment

  • High Place Phenomenon Index (HPPI)

    Baseline, Immediately Post-Treatment; 1 Week Post-Treatment

  • +2 more other outcomes

Study Arms (3)

Virtual Reality Exposure

EXPERIMENTAL

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)

In Vivo Exposure

EXPERIMENTAL

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)

Waitlist Control

NO INTERVENTION

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

Interventions

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.

In Vivo Exposure

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.

Virtual Reality Exposure

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Already receiving therapy specifically for fear of heights.
  • Has any contraindications to using a virtual reality headset.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Notre Dame

Notre Dame, Indiana, 46556, United States

Location

MeSH Terms

Conditions

AcrophobiaPhobia, SpecificAnxiety Disorders

Interventions

Implosive TherapyVirtual Reality Exposure Therapy

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Desensitization, PsychologicBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Jennifer L Hames, Ph.D.

    University of Notre Dame

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Clinical Professor & Clinic Director

Study Record Dates

First Submitted

January 28, 2021

First Posted

February 4, 2021

Study Start

June 11, 2018

Primary Completion

March 6, 2019

Study Completion

March 6, 2019

Last Updated

February 8, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Study protocols and de-identified data will be shared at the request of other researchers.

Locations