Clinical trial NCT03917433: Augmenting Virtual Reality Exposure Therapy for Acrophobia
Official title: Augmenting Virtual Reality Exposure Therapy for Acrophobia With Tactile Feedback and Point-based Rewards
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Specific Phobia
Anxiety Disorders
Fear of Heights
Acrophobia
Keywords: exposure therapy
virtual reality
acrophobia
fear of heights
Lead sponsor: University of Nevada, Reno
Sponsor class: OTHER
First posted: 2019-04-17
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Behavioral approach test (BAT)- generalization context
timeFrame: Change from baseline to one-month follow-up
measure: Behavioral approach test (BAT) -treatment context
timeFrame: Change from baseline to one-month follow-up
measure: Acrophobia Questionnaire (AQ)
timeFrame: Change from baseline to one-month follow-up
measure: Heights Interpretation Questionnaire (HIQ)
timeFrame: Change from baseline to one-month follow-up
Secondary outcomes:
measure: Anxiety Disorders Interview Schedule for the Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 - Specific Phobia Module
timeFrame: Change from baseline to one-month follow-up
measure: Treatment Drop-out Questionnaire
timeFrame: Post-treatment (about 1 week)
measure: Willingness to continue exposure therapy
timeFrame: Post-treatment (about 1 week)
Other outcomes:
Locations:
city: Reno
country: United States
facility: University of Nevada Reno
state: Nevada
Study officials:
References: