Low-immersion (Mobile Device)SET-VRNCT06706245
Developing a Virtual Reality Training Tool for Exposure Therapy: Simulated Exposure Trainer (SET)
A study testing SET-VR (computer) and SET-VR (headset) in people with Low-immersion (Mobile Device) and High-immersion (Head Mounted Display), run by Bradley Hospital at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Low-immersion (Mobile Device), High-immersion (Head Mounted Display)
- What is being tested?
- SET-VR (computer) and SET-VR (headset)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2023to 3 Jul 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Found study procedures to be unacceptable during the consent process
Trial locations and contacts
1 site in 1 country.
United States1 site
Pediatric Anxiety Research Center at Bradley Hospital
Providence, Rhode Island, 02915
About this study
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.
Read the 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.
- Being tested
- SET-VR (computer), SET-VR (headset)
- Keywords
- Virtual reality, exposure to exposure, therapist negative beliefs, exposure therapy, evidence-based practices, Simulated Exposure Trainer, virtual training program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SET-VR (computer)Behavioural
Low-immersive version of the SET-VR program
SET-VR (headset)Behavioural
High-immersive version of the SET-VR program
| Study group | Role | What they receive |
|---|---|---|
| Low-immersion (mobile device) | Active comparator | Not described Receives: Behavioral: SET-VR (computer) |
| High-immersion (head-mounted display) | Experimental | Not described Receives: Behavioral: SET-VR (headset) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 outcomes (2)
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.
Measured: 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.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2024
- Study start1 Dec 2023
- Primary completion30 May 2024
- Study completion3 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Low-immersion (Mobile Device)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bradley Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Joshua Kemp, Bradley Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06706245
- Sponsor's protocol ID
- 841660
- Other IDs
- 1R41MH131229-01, 5R41MH131229-02
- Acronym
- SET-VR
- Status last verified
- Jun 2025
- First submitted
- 19 Nov 2024
- Last updated
- 19 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing a Virtual Reality Training Tool for Exposure Therapy: Simulated Exposure Trainer (SET)
- ClinicalTrials.gov ID
- NCT06706245
- Acronym / sponsor ID
- SET-VR / 841660
- Keywords
- Virtual reality, exposure to exposure, therapist negative beliefs, exposure therapy, evidence-based practices, Simulated Exposure Trainer, virtual training program
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Bradley HospitalUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 30 May 2024 (actual)
- Study completion
- 3 Jul 2024 (actual)
- First posted
- 26 Nov 2024 (actual)
- Results
- Posted 19 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low-immersion (mobile device) | Active comparator | Behavioral: SET-VR (computer) |
| High-immersion (head-mounted display) | Experimental | Behavioral: SET-VR (headset) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Found study procedures to be unacceptable during the consent process
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SET-VR (computer)Low-immersive version of the SET-VR program | Behavioural | Low-immersion (mobile device) |
| SET-VR (headset)High-immersive version of the SET-VR program | Behavioural | High-immersion (head-mounted display) |
Primary outcome
Therapist Negative Beliefs About Exposure Scale (TBES)
Time frame: 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)
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.
2 secondary outcomes
Exposure Self-Efficacy
Time frame: 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
Time frame: 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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SET-VR (computer) and SET-VR (headset) in people with Low-immersion (Mobile Device) and High-immersion (Head Mounted Display), run by Bradley Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Therapist Negative Beliefs About Exposure Scale (TBES) (time frame: 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2025.