NCT03917433

Brief Summary

This study will examine whether tactile feedback and point-based rewards can be used to improve outcomes from virtual reality exposure therapy for acrophobia.

Trial Health

33
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
128

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
suspended

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 10, 2019

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

April 11, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 17, 2019

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
Last Updated

May 18, 2022

Status Verified

May 1, 2022

Enrollment Period

3.7 years

First QC Date

April 11, 2019

Last Update Submit

May 16, 2022

Conditions

Keywords

exposure therapyvirtual realityacrophobiafear of heights

Outcome Measures

Primary Outcomes (4)

  • Behavioral approach test (BAT)- generalization context

    Participants will walk up a staircase until they reach the highest level they can complete. During each BAT, we will assess fear response behaviorally (highest step reached up to 101 steps), physiologically (heart rate and electrodermal activity), and subjectively (self reported levels of anticipated and peak fear).

    Change from baseline to one-month follow-up

  • Behavioral approach test (BAT) -treatment context

    Participants will stand on a plank in virtual reality and raise the plank until they reach the highest level they can complete. During each BAT, we will assess fear response behaviorally (highest step reached up to 70 steps), physiologically (heart rate and electrodermal activity), and subjectively (self reported levels of anticipated and peak fear).

    Change from baseline to one-month follow-up

  • Acrophobia Questionnaire (AQ)

    Participants will complete the AQ, a 40-item questionnaire that assesses self-reported anxiety and avoidance related to acrophobia. Scores for each subscale are summed, and totals range from 0 to 120 for each subscale, with higher scores indicating greater anxiety or avoidance.

    Change from baseline to one-month follow-up

  • Heights Interpretation Questionnaire (HIQ)

    Participants will complete 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.

    Change from baseline to one-month follow-up

Secondary Outcomes (3)

  • Anxiety Disorders Interview Schedule for the Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 - Specific Phobia Module

    Change from baseline to one-month follow-up

  • Treatment Drop-out Questionnaire

    Post-treatment (about 1 week)

  • Willingness to continue exposure therapy

    Post-treatment (about 1 week)

Study Arms (4)

Exposure with Tactile Feedback

EXPERIMENTAL

Participant completes virtual reality exposure therapy for acrophobia involving walking across a plank at higher and higher levels in a virtual city environment. In the real world, the participant walks across an actual wooden plank on the floor, which mirrors the plank in the virtual world.

Behavioral: Virtual Reality Exposure TherapyBehavioral: Tactile Feedback

Exposure with Point-based Rewards

EXPERIMENTAL

Participant completes virtual reality exposure therapy for acrophobia involving walking across a plank at higher and higher levels in a virtual city environment. The participant has the opportunity to pop balloons upon reaching the ends of the plank to gain points. Participant's popping instrument in the virtual world upgrades as more points are accumulated.

Behavioral: Virtual Reality Exposure TherapyBehavioral: Point-based Rewards

Exposure with Tactile Feedback and Point-based Rewards

EXPERIMENTAL

Participant completes virtual reality exposure therapy for acrophobia involving walking across a plank at higher and higher levels in a virtual city environment. In the real world, the participant walks across an actual wooden plank on the floor, which mirrors the plank in the virtual world. Also, the participant has the opportunity to pop balloons upon reaching the ends of the plank to gain points. Participant's popping instrument in the virtual world upgrades as more points are accumulated.

Behavioral: Virtual Reality Exposure TherapyBehavioral: Tactile FeedbackBehavioral: Point-based Rewards

Virtual Reality Exposure Therapy Alone

OTHER

Participant completes virtual reality exposure therapy for acrophobia involving walking across a plank at higher and higher levels in a virtual city environment.

Behavioral: Virtual Reality Exposure Therapy

Interventions

Participant completes virtual reality exposure therapy for acrophobia involving walking across a plank at higher and higher levels in a virtual city environment.

Exposure with Point-based RewardsExposure with Tactile FeedbackExposure with Tactile Feedback and Point-based RewardsVirtual Reality Exposure Therapy Alone

In the real world, the participant walks across an actual wooden plank on the floor, which mirrors the plank in the virtual world.

Exposure with Tactile FeedbackExposure with Tactile Feedback and Point-based Rewards

Participant has the opportunity to pop balloons upon reaching the ends of the plank to gain points. Participant's popping instrument in the virtual world upgrades as more points are accumulated.

Exposure with Point-based RewardsExposure with Tactile Feedback and Point-based Rewards

Eligibility Criteria

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

You may qualify if:

  • Fluent in English
  • Indicates sufficient fear of heights based on responses (a) on a self-report questionnaire (the Acrophobia Questionnaire) administered at prescreening, and (b) on Behavioral Avoidance Tests administered at baseline.

You may not qualify if:

  • Already receiving exposure therapy for height phobia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Nevada Reno

Reno, Nevada, 89557, United States

Location

MeSH Terms

Conditions

Phobia, SpecificAnxiety DisordersAcrophobia

Interventions

Virtual Reality Exposure Therapy

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Desensitization, PsychologicBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned to receive virtual reality exposure therapy with tactile feedback, point-based rewards, both tactile feedback and point-based rewards, or neither tactile feedback nor point-based rewards.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Clinical Psychology

Study Record Dates

First Submitted

April 11, 2019

First Posted

April 17, 2019

Study Start

April 10, 2019

Primary Completion

January 1, 2023

Study Completion

January 1, 2023

Last Updated

May 18, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

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

Locations