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

NCT ID: NCT06706245

Last Updated: 2025-06-19

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-01

Study Completion Date

2024-07-03

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Low-immersion (Mobile Device) High-immersion (Head Mounted Display)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Low-immersion (mobile device)

Group Type ACTIVE_COMPARATOR

SET-VR (computer)

Intervention Type BEHAVIORAL

Low-immersive version of the SET-VR program

High-immersion (head-mounted display)

Group Type EXPERIMENTAL

SET-VR (headset)

Intervention Type BEHAVIORAL

High-immersive version of the SET-VR program

Interventions

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SET-VR (computer)

Low-immersive version of the SET-VR program

Intervention Type BEHAVIORAL

SET-VR (headset)

High-immersive version of the SET-VR program

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Bradley Hospital

OTHER

Sponsor Role lead

Responsible Party

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Joshua Kemp

Staff Clinician / Assistant Professor (Research)

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Pediatric Anxiety Research Center at Bradley Hospital

Providence, Rhode Island, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

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Other Identifiers

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1R41MH131229-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

5R41MH131229-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

841660

Identifier Type: -

Identifier Source: org_study_id

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