Augmenting Virtual Reality Exposure Therapy for Acrophobia

May 16, 2022 updated by: Cynthia Lancaster, University of Nevada, Reno

Augmenting Virtual Reality Exposure Therapy for Acrophobia With Tactile Feedback and Point-based Rewards

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Suspended

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Exposure therapy is one of the most potent techniques available for treating anxiety-related disorders, including specific phobia. However, estimates suggest that 10-48% of anxiety patients do not fully respond to exposure therapy. Meta-analyses demonstrate that virtual reality exposure therapy (VRET) is equally effective as traditional, in vivo ('in life') exposure therapy. Furthermore, individuals with anxiety disorders report greater preference (and lower likelihood of treatment refusal) for VR, rather than in vivo, exposure therapy. Although VRET has well-established efficacy and is rapidly growing in popularity, there has been very little research evaluating how specific elements of VR game design might be used to improve outcomes from VRET. This study evaluates two game design elements that we hypothesize will improve VRET outcomes: tactile feedback and a point-based reward system. Tactile feedback (TF; i.e., touching a real object that matches an element in the VR environment) enhances sense of presence in VR. Higher presence activates anxiety during VRET, which is essential for promoting the active mechanisms of exposure therapy and may also improve treatment retention. On the other hand, point-based rewards (PR) in games enhance sense of competence (i.e., sense of progress and achievement), and increase both enjoyment and likelihood of future use of games. Furthermore, several studies demonstrate that PR improves traditionally difficult-to-change health behaviors, such as increasing exercise frequency and reducing misuse of pain medications. Although this research is promising, the impact of PR on VRET is unknown. To test the influence of TF and PR on VRET outcomes, we will randomize participants with acrophobia to receive (a) standard virtual reality exposure therapy, (b) VRET with tactile feedback, (c) VRET with a point-based reward system, or (d) VRET with tactile feedback and a point-based reward system. Participants' fear reactivity will be assessed with behavioral, physiological, and subjective/self-report measures at baseline, post-treatment, and follow-up.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
128

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Nevada
      • Reno, Nevada, United States, 89557
        • University of Nevada Reno

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Already receiving exposure therapy for height phobia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Exposure with Tactile Feedback
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 Therapy
Participant completes virtual reality exposure therapy for acrophobia involving walking across a plank at higher and higher levels in a virtual city environment.
Behavioral: Tactile Feedback
In the real world, the participant walks across an actual wooden plank on the floor, which mirrors the plank in the virtual world.
Experimental: Exposure with Point-based Rewards
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 Therapy
Participant completes virtual reality exposure therapy for acrophobia involving walking across a plank at higher and higher levels in a virtual city environment.
Behavioral: 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.
Experimental: Exposure with Tactile Feedback and Point-based Rewards
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 Therapy
Participant completes virtual reality exposure therapy for acrophobia involving walking across a plank at higher and higher levels in a virtual city environment.
Behavioral: Tactile Feedback
In the real world, the participant walks across an actual wooden plank on the floor, which mirrors the plank in the virtual world.
Behavioral: 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.
Other: Virtual Reality Exposure Therapy Alone
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
Participant completes virtual reality exposure therapy for acrophobia involving walking across a plank at higher and higher levels in a virtual city environment.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Behavioral approach test (BAT)- generalization context
Time Frame: Change from baseline to one-month follow-up
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
Time Frame: Change from baseline to one-month follow-up
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)
Time Frame: Change from baseline to one-month follow-up
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)
Time Frame: Change from baseline to one-month follow-up
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Anxiety Disorders Interview Schedule for the Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 - Specific Phobia Module
Time Frame: Change from baseline to one-month follow-up
Participants will be given a structured interview to determine whether they meet diagnostic criteria for specific phobia.
Change from baseline to one-month follow-up
Treatment Drop-out Questionnaire
Time Frame: Post-treatment (about 1 week)
Experimenters will record whether or not participants drop out of treatment. This will be operationalized as beginning virtual reality exposure therapy, but discontinuing the study before the two-session treatment is complete.
Post-treatment (about 1 week)
Willingness to continue exposure therapy
Time Frame: Post-treatment (about 1 week)
This scale will assess assess whether participants would be willing (from 0% to 100%) to use the heights exposure program at home, or to return to the lab for another therapy session.
Post-treatment (about 1 week)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Nevada, Reno

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 10, 2019

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 11, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 12, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 17, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 18, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 16, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1345559-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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