Developing a Virtual Reality Training Tool for Exposure Therapy: Simulated Exposure Trainer (SET) (SET-VR)

The goal of this study is to develop a targeted virtual training program (Simulated Exposure Trainer; SET) for exposure therapy. Two platforms with differing levels of immersion (low - mobile device; high - head mounted display) will be evaluated based on their usability and engagement of an empirically-derived training target (i.e., therapist negative beliefs). Target engagement will be evaluated by applying an experimental therapeutics framework during a brief training trial.

Study Overview

• Status: Completed
• Conditions: Low-immersion (Mobile Device); High-immersion (Head Mounted Display)
• Intervention / Treatment: Behavioral: SET-VR (computer); Behavioral: SET-VR (headset)

Detailed Description

Despite the existence of numerous, well-established evidence-based practices (EBPs) for mental disorders, it has been difficult to disseminate these practices in community settings. Exposure therapy for anxiety disorders represents one of the most glaring examples of this research-to-practice gap. Just as patients are anxious about approaching their fears, therapists are often reluctant to use exposure therapy due to their own anxious beliefs that it may be dangerous and/or intolerable for patients, even after receiving specialized exposure training. Emerging training research suggests the inclusion of targeted behavioral strategies (i.e., role play, self-exposure) can reduce anxious beliefs above and beyond standard didactic training sessions. By leveraging the same behavior change principles that reduce patient anxiety (i.e., exposure), behavioral strategies can be tailored to target therapists' anxious beliefs about the treatment (i.e., conduct training as "exposure to exposure"). Unfortunately, current experiential training tasks have failed to closely replicate commonly feared clinical contexts, and as a result lack the necessary potency to potentially overcome therapist-level barriers for uptake and quality treatment delivery following training. Virtual reality (VR) has demonstrated utility as a potent and cost-effective approach for delivering exposure. We plan to investigate the application of VR as a tailored training tool (i.e., virtual "exposure to exposure" for therapists) capable of enhancing the quantity and quality of experiential learning that is lacking in current exposure training initiatives. This study will test the implementation of a VR training program on both a low-immersion (i.e., mobile device) and high-immersion (i.e., head mounted display) platform to assess which platform provides the ideal balance of immersion, usability, target engagement, and scalability. The study involves a clinical training trial to establish target engagement. Usability and target engagement information from this pilot trial will support a Phase II project aimed at building out and broadly disseminating the VR-enhanced training approach.

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02915
      • Pediatric Anxiety Research Center at Bradley Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Bachelor's level of education (or higher)
• Able to come to study site in-person for experiential training
• Has the ability to provide some sort of clinical care to patients

Exclusion Criteria:

• Found study procedures to be unacceptable during the consent process

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Low-immersion (mobile device)	Behavioral: SET-VR (computer); Low-immersive version of the SET-VR program
Experimental: High-immersion (head-mounted display)	Behavioral: SET-VR (headset); High-immersive version of the SET-VR program

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Therapist Negative Beliefs About Exposure Scale (TBES)	The Therapist Negative Beliefs about Exposure Scale (TBES) assesses the extent to which therapists agree with 21 negative beliefs about exposure therapy (e.g., "most clients have difficulty tolerating the distress exposure therapy evokes"). Items are rated on a 5-point scale from 0 ("disagree strongly") to 4 ( "agree strongly"). Possible scores range from 0 to 84, with a higher score indicating more negative beliefs about exposure.	Before workshop starts (Baseline); immediately after 4-hour didactic portion of training (Post-didactic), immediately after remaining workshop activities (End of workshop), one month after workshop (Follow-up)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exposure Self-Efficacy	This is a 27-item measure of therapists' confidence in delivering exposure therapy. The first 8 items are about the therapist's ability to help patients learn skills related to exposure (e.g., "I feel confident in my ability to help my clients identify how avoidance is maintaining their fear"), and the remaining 19 items assess the therapist's confidence with implementing exposure various aspects of exposure (e.g., "I feel confident in my ability to conduct imaginal exposure"). Items are rated scale ranging from 1 ("not confident") to 5 ("very confident"). This measure has demonstrated high internal consistency and predictive validity in determining the frequency of self-reported clinical use of exposure therapy.	Before workshop starts (Baseline); immediately after 4-hour didactic portion of training (Post-didactic), immediately after remaining workshop activities (End of workshop), one month after workshop (Follow-up)
Exposure Knowledge	We condensed the original 49-item Exposure Knowledge measure into 12 multiple-choice items that best fit the didactic content of the training (e.g., "Why is it important to block avoidance during exposure tasks?"). The total score is the percentage out of 100 of correct answers.	Before workshop starts (Baseline); immediately after 4-hour didactic portion of training (Post-didactic), immediately after remaining workshop activities (End of workshop), one month after workshop (Follow-up)

Collaborators and Investigators

• Sponsor: Bradley Hospital
• Collaborators: National Institute of Mental Health (NIMH)

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2023
• Primary Completion (Actual): May 30, 2024
• Study Completion (Actual): July 3, 2024

Study Registration Dates

• First Submitted: November 19, 2024
• First Submitted That Met QC Criteria: November 22, 2024
• First Posted (Actual): November 26, 2024

Study Record Updates

• Last Update Posted (Actual): June 19, 2025
• Last Update Submitted That Met QC Criteria: June 4, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: exposure therapy; Virtual reality; evidence-based practices; exposure to exposure; therapist negative beliefs; Simulated Exposure Trainer; virtual training program
• Other Study ID Numbers: 841660; 1R41MH131229-01 (U.S. NIH Grant/Contract); 5R41MH131229-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No