Trial Outcomes & Findings for Developing a Virtual Reality Training Tool for Exposure Therapy: Simulated Exposure Trainer (SET) (NCT NCT06706245)

NCT ID: NCT06706245

Last Updated: 2025-06-19

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

42 participants

Primary outcome timeframe

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 posted on

2025-06-19

Participant Flow

Participant milestones

Participant milestones
Measure
Low-immersion (Mobile Device)
SET-VR (computer): Low-immersive version of the SET-VR program
High-immersion (Head-mounted Display)
SET-VR (headset): High-immersive version of the SET-VR program
Overall Study
STARTED
21
20
Overall Study
COMPLETED
21
20
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

2 participants did not report gender.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Low-immersion (Mobile Device)
n=21 Participants
SET-VR (computer): Low-immersive version of the SET-VR program
High-immersion (Head-mounted Display)
n=20 Participants
SET-VR (headset): High-immersive version of the SET-VR program
Total
n=41 Participants
Total of all reporting groups
Age, Continuous
42 years
n=21 Participants
37 years
n=20 Participants
40 years
n=41 Participants
Sex: Female, Male
Female
17 Participants
n=20 Participants • 2 participants did not report gender.
17 Participants
n=19 Participants • 2 participants did not report gender.
34 Participants
n=39 Participants • 2 participants did not report gender.
Sex: Female, Male
Male
3 Participants
n=20 Participants • 2 participants did not report gender.
2 Participants
n=19 Participants • 2 participants did not report gender.
5 Participants
n=39 Participants • 2 participants did not report gender.
Ethnicity (NIH/OMB)
Hispanic or Latino
1 Participants
n=21 Participants
1 Participants
n=20 Participants
2 Participants
n=41 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
20 Participants
n=21 Participants
19 Participants
n=20 Participants
39 Participants
n=41 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=21 Participants
0 Participants
n=20 Participants
0 Participants
n=41 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Low-immersion (Mobile Device)
n=21 Participants
SET-VR (computer): Low-immersive version of the SET-VR program
High-immersion (Head-mounted Display)
n=20 Participants
SET-VR (headset): High-immersive version of the SET-VR program
Therapist Negative Beliefs About Exposure Scale (TBES)
Baseline
28.76 score on a scale
Standard Deviation 8.96
30.9 score on a scale
Standard Deviation 10.49
Therapist Negative Beliefs About Exposure Scale (TBES)
Post-Didactic
21.19 score on a scale
Standard Deviation 10.94
21.2 score on a scale
Standard Deviation 10.03
Therapist Negative Beliefs About Exposure Scale (TBES)
Post-Experiential
16.33 score on a scale
Standard Deviation 9.06
16.65 score on a scale
Standard Deviation 10.50
Therapist Negative Beliefs About Exposure Scale (TBES)
Follow Up
14.71 score on a scale
Standard Deviation 10.23
15.95 score on a scale
Standard Deviation 10.61

SECONDARY outcome

Timeframe: 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)

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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)

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.

Outcome measures

Outcome measures
Measure
Low-immersion (Mobile Device)
n=21 Participants
SET-VR (computer): Low-immersive version of the SET-VR program
High-immersion (Head-mounted Display)
n=20 Participants
SET-VR (headset): High-immersive version of the SET-VR program
Exposure Knowledge
Baseline
42.46 percentage of correct answers
Standard Deviation 15.34
34.17 percentage of correct answers
Standard Deviation 15.50
Exposure Knowledge
Post-Didactic
50.79 percentage of correct answers
Standard Deviation 18.80
45.83 percentage of correct answers
Standard Deviation 16.11
Exposure Knowledge
Post-Experiential
51.98 percentage of correct answers
Standard Deviation 16.44
45.42 percentage of correct answers
Standard Deviation 13.91
Exposure Knowledge
Follow Up
53.57 percentage of correct answers
Standard Deviation 18.92
45.83 percentage of correct answers
Standard Deviation 16.11

Adverse Events

Low-immersion (Mobile Device)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

High-immersion (Head-mounted Display)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Joshua Kemp, Assistant Professor

Brown University Health

Phone: 4014321466

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place