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| ID | Type | Description | Link |
|---|---|---|---|
| 1R41MH131229-01 | U.S. NIH Grant/Contract | View source | |
| 5R41MH131229-02 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low-immersion (mobile device) | Active Comparator |
| |
| High-immersion (head-mounted display) | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SET-VR (computer) | Behavioral | Low-immersive version of the SET-VR program |
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| 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) |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pediatric Anxiety Research Center at Bradley Hospital | Providence | Rhode Island | 02915 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Low-immersion (Mobile Device) | SET-VR (computer): Low-immersive version of the SET-VR program |
| FG001 | High-immersion (Head-mounted Display) | SET-VR (headset): High-immersive version of the SET-VR program |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Low-immersion (Mobile Device) | SET-VR (computer): Low-immersive version of the SET-VR program |
| BG001 | High-immersion (Head-mounted Display) | SET-VR (headset): High-immersive version of the SET-VR program |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | 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) |
|
From enrollment through study completion (average of 2.2 months).
Definitions of adverse event and/or serious adverse event used to collect adverse event information does not differ from clinicaltrials.gov definitions.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Low-immersion (Mobile Device) | SET-VR (computer): Low-immersive version of the SET-VR program |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joshua Kemp, Assistant Professor | Brown University Health | 4014321466 | joshua_kemp@brown.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 27, 2022 | Jun 4, 2025 | Prot_SAP_000.pdf |
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| SET-VR (headset) | Behavioral | High-immersive version of the SET-VR program |
|
| 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) |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | 2 participants did not report gender. | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| OG001 |
| High-immersion (Head-mounted Display) |
SET-VR (headset): High-immersive version of the SET-VR program |
|
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| Secondary | 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. | Not Posted | 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) | Participants |
| Secondary | 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. | Posted | Mean | Standard Deviation | percentage 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) |
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| 0 |
| 21 |
| 0 |
| 21 |
| 0 |
| 21 |
| EG001 | High-immersion (Head-mounted Display) | SET-VR (headset): High-immersive version of the SET-VR program | 0 | 20 | 0 | 20 | 0 | 20 |
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| Unknown or Not Reported |
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| Post-Experiential |
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| Follow Up |
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