Augmenting Virtual Reality Exposure Therapy for Acrophobia

Sponsor
University of Nevada, Reno (Other)
Overall Status
Suspended
CT.gov ID
NCT03917433
Collaborator
(none)
128
1
4
44.7
2.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Virtual Reality Exposure Therapy
  • Behavioral: Tactile Feedback
  • Behavioral: Point-based Rewards
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
128 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
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.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.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Augmenting Virtual Reality Exposure Therapy for Acrophobia With Tactile Feedback and Point-based Rewards
Actual Study Start Date :
Apr 10, 2019
Anticipated Primary Completion Date :
Jan 1, 2023
Anticipated Study Completion Date :
Jan 1, 2023

Arms and Interventions

Arm Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

  1. Behavioral approach test (BAT)- generalization context [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).

  2. Behavioral approach test (BAT) -treatment context [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).

  3. Acrophobia Questionnaire (AQ) [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.

  4. Heights Interpretation Questionnaire (HIQ) [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.

Secondary Outcome Measures

  1. 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]

    Participants will be given a structured interview to determine whether they meet diagnostic criteria for specific phobia.

  2. Treatment Drop-out Questionnaire [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.

  3. Willingness to continue exposure therapy [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Nevada Reno Reno Nevada United States 89557

Sponsors and Collaborators

  • University of Nevada, Reno

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Cynthia Lancaster, Assistant Professor, Clinical Psychology, University of Nevada, Reno
ClinicalTrials.gov Identifier:
NCT03917433
Other Study ID Numbers:
  • 1345559-1
First Posted:
Apr 17, 2019
Last Update Posted:
May 18, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Cynthia Lancaster, Assistant Professor, Clinical Psychology, University of Nevada, Reno
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 18, 2022