NCT06706245

Brief 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 training target (i.e., therapist negative beliefs). Target engagement will be evaluated by applying an experimental therapeutics framework during a brief training trial.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 3, 2024

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 19, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 26, 2024

Completed
7 months until next milestone

Results Posted

Study results publicly available

June 19, 2025

Completed
Last Updated

June 19, 2025

Status Verified

June 1, 2025

Enrollment Period

6 months

First QC Date

November 19, 2024

Results QC Date

May 19, 2025

Last Update Submit

June 4, 2025

Conditions

Keywords

Virtual realityexposure to exposuretherapist negative beliefsexposure therapyevidence-based practicesSimulated Exposure Trainervirtual training program

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Exposure Self-Efficacy

    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

    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)

Study Arms (2)

Low-immersion (mobile device)

ACTIVE COMPARATOR
Behavioral: SET-VR (computer)

High-immersion (head-mounted display)

EXPERIMENTAL
Behavioral: SET-VR (headset)

Interventions

Low-immersive version of the SET-VR program

Low-immersion (mobile device)

High-immersive version of the SET-VR program

High-immersion (head-mounted display)

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Found study procedures to be unacceptable during the consent process

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pediatric Anxiety Research Center at Bradley Hospital

Providence, Rhode Island, 02915, United States

Location

Results Point of Contact

Title
Joshua Kemp, Assistant Professor
Organization
Brown University Health

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Staff Clinician / Assistant Professor (Research)

Study Record Dates

First Submitted

November 19, 2024

First Posted

November 26, 2024

Study Start

December 1, 2023

Primary Completion

May 30, 2024

Study Completion

July 3, 2024

Last Updated

June 19, 2025

Results First Posted

June 19, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations