Recruiting

Virtual Reality Therapy

Sponsor:

The University of Texas Health Science Center, Houston

Code:

NCT05319509

Conditions

Anxiety

Eligibility Criteria

Sex: All

Age: 18 - 30

Healthy Volunteers: Not accepted

Interventions

gameChange

Study Details

Brief summary:

The purpose of this study is to assess changes in self-reported anxiety over the course of six virtual reality (VR) sessions and to assess changes in academic self-efficacy, as well as examine the feasibility and acceptability of a relatively short and time intensive VR intervention (i.e.,six sessions over the course of three weeks) for reducing anxiety symptoms in college students.

Conditions

Anxiety

Study ID

NCT05319509

Start date

Apr 1, 2022

Status verified date

Jun, 2025

Completion date

Aug 1, 2027

Anticipated

Primary completion date

Apr 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 30

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • enrolled in The University of Texas Health Science Center School of Public Health San Antonio regional campus
  • competent in English
  • total score of at least 3 on the Generalized Anxiety Disorder (GAD-2)

Exclusion Criteria:

  • Currently receiving psychological treatment for anxiety symptoms, or has received treatment in the last year.
  • Report photosensitive epilepsy.
  • Report stereoscopic vision or balance problems

Study Design

Enrollment

100 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: gameChange

Interventions

gameChange

Staff will explain the rationale behind gameChange, and briefly explain the different scenarios: a doctor's office, a waiting room, a pub, a café, a grocery store, a public street and a bus. Each scenario contains five levels, each increasing with anxiety stimuli and certain tasks the participant must complete. The participant will put on the Oculus headset, and go through a preliminary orientation game. The headset will be casted to an external monitor. Once they start gameChange, it will take the participants to the virtual therapist's room. They will be asked to choose which scenario they would like to participate in first and will complete all five levels for one scenario. Research staff will be taking event sampling-style observations of the participant. After completion of the levels, the participant will return to the virtual therapist's room for debriefing, and then will be asked to exit the game.

Primary outcome measure

  • Change in state anxiety as assessed by the Liebowitz Social Anxiety Scale-Self Report version (LSAS-SR) [ Time Frame: before first session in week 1, before third session in week 2 and before sixth session in week 3 ]
  • Change in depressive symptoms as assessed by score on the Patient Health Questionnaire-4 (PHQ-4) [ Time Frame: Baseline(before the first session in week 1) ]
  • Change in anxiety related behaviors such as rate of speech [ Time Frame: Week 1(session1 and session 2), week 2( session 3 and session 4), week 3 (session 5 and session 6) ]
  • Change in anxiety related behaviors such as volume of speech [ Time Frame: Week 1(session1 and session 2), week 2( session 3 and session 4), week 3 (session 5 and session 6) ]
  • Change in anxiety related behaviors such as Negative self-talk [ Time Frame: Week 1(session1 and session 2), week 2( session 3 and session 4), week 3 (session 5 and session 6) ]
  • Change in anxiety related behaviors such as Utterances about experience [ Time Frame: Week 1(session1 and session 2), week 2( session 3 and session 4), week 3 (session 5 and session 6) ]
  • Change in anxiety related behaviors such as Laughter [ Time Frame: Week 1(session1 and session 2), week 2( session 3 and session 4), week 3 (session 5 and session 6) ]
  • Change in Psychomotor agitation such as pacing [ Time Frame: Week 1(session1 and session 2), week 2( session 3 and session 4), week 3 (session 5 and session 6) ]
  • Change in Psychomotor agitation such as Fidgeting [ Time Frame: Week 1(session1 and session 2), week 2( session 3 and session 4), week 3 (session 5 and session 6) ]
  • Change in Psychomotor agitation such as Rubbing hands/neck/head [ Time Frame: Week 1(session1 and session 2), week 2( session 3 and session 4), week 3 (session 5 and session 6) ]
  • Change in physiology such as perspiration [ Time Frame: Week 1(session1 and session 2), week 2( session 3 and session 4), week 3 (session 5 and session 6) ]

Central Contacts and Locations

Central contacts

Tsai Jack, PhD

210-276-9022Jack.Tsai@uth.tmc.edu

Abigail Lipe

210-722-8218Abigail.R.Lipe@uth.tmc.edu

Locations

The University of Texas Health Science Center at Houston

Recruiting

Houston, Texas, United States, 77030

Contacts

Tsai Jack, PhD

210-276-9022Jack.Tsai@uth.tmc.edu

Abigail Lipe

210-722-8218Abigail.R.Lipe@uth.tmc.edu

More Information

Sponsor

The University of Texas Health Science Center, Houston

Last update posted

Jun 12, 2025

Last verified

Jun, 2025

Keywords

  • virtual reality
  • college students

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The University of Texas Health Science Center, Houston on 2025-06-12.