Pilot Study of Virtual Reality Therapy for Students With Anxiety

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.

Study Overview

• Status: Recruiting
• Conditions: Anxiety
• Intervention / Treatment: Device: gameChange

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tsai Jack, PhD; Phone Number: 210-276-9022; Email: Jack.Tsai@uth.tmc.edu
• Study Contact Backup: Name: Abigail Lipe; Phone Number: 210-722-8218; Email: Abigail.R.Lipe@uth.tmc.edu

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • The University of Texas Health Science Center at Houston
      • Contact: Tsai Jack, PhD; Phone Number: 210-276-9022; Email: Jack.Tsai@uth.tmc.edu
      • Contact: Abigail Lipe; Phone Number: 210-722-8218; Email: Abigail.R.Lipe@uth.tmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: gameChange

Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in state anxiety as assessed by the Liebowitz Social Anxiety Scale-Self Report version (LSAS-SR)	The LSAS-SR questionnaire is composed of 24 items divided into 2 subscales, 13 concerning performance anxiety, and 11 pertaining to social situations. The 24 items are first rated on a Likert Scale from 0(none) to 3(severe) on fear felt during the situations, and then the same items are rated from 0(never)-3(usually)regarding avoidance of the situation. Combining the total scores for the Fear and Avoidance sections provides an overall score with a maximum of 144 points. Score of 30 or less indicates social anxiety disorder(SAD) is unlikely, score of 30-60 shows that SAD is probable and score 60-90 indicates that SAD is highly probable.	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)	The PHQ-4 questionnaire consists of 4 questions and each is rated on a 4 point scale from 0(not at all) to 3(every day) for a maximum score of 12,a higher number indicating a worse outcome.	Baseline(before the first session in week 1)
Change in anxiety related behaviors such as rate of speech	Anxiety-related behaviors will be recorded using an event sampling observation guide	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	Anxiety-related behaviors will be recorded using an event sampling observation guide	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	Anxiety-related behaviors will be recorded using an event sampling observation guide	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	Anxiety-related behaviors will be recorded using an event sampling observation guide	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	Anxiety-related behaviors will be recorded using an event sampling observation guide	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	Anxiety-related behaviors will be recorded using an event sampling observation guide	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	Anxiety-related behaviors will be recorded using an event sampling observation guide	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	Anxiety-related behaviors will be recorded using an event sampling observation guide	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	Anxiety-related behaviors will be recorded using an event sampling observation guide	Week 1(session1 and session 2), week 2( session 3 and session 4), week 3 (session 5 and session 6)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in self-reported academic performance as assessed by the Motivated Strategies for Learning Questionnaire (MSLQ)	The MSLQ questionnaire consists of 9 questions each one is scored from 1= not at all true of me to 7=very true of me, a higher number indicating a better outcome with a maximum score of 63	before first session in week 1, before third session in week 2 and before sixth session in week 3
change in feasibility as assessed by the rating on a short questionnaire	The usability questionnaire is developed by gameChange about the ease of VR software use, believability of VR environment, and level of engagement. this consists of 5 questions and each one is scored form 1(very difficult) to 5(very easy) for a maximum score of 25, a higher number indicating more easiness in using the VR software	after the third session in week 2 , after sixth session in week 3
Change in acceptability as assessed by the rating on a short questionnaire	The usability questionnaire is developed by gameChange about the ease of VR software use, believability of VR environment, and level of engagement. this consists of 5 questions and each is scored form 1(strongly disagree) to 5(strongly agree) for a maximum score of 25	after the third session in week 2 , after sixth session in week 3
Change in perceived presence in the virtual environment (as indicated by continuous score on the Igroup Presence Questionnaire (IPQ)	There are 14 questions and each one is scored form -3 to +3. A total negative score indicates that the participant personally felt very disconnected from VR world, and that they lacked believable presence within world, and rather felt like they were manipulating a machine from an outside perspective.	after the third session in week 2 and the sixth session in week 3

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Investigators: Principal Investigator: Tsai Jack, PhD, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2022
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): August 1, 2027

Study Registration Dates

• First Submitted: March 31, 2022
• First Submitted That Met QC Criteria: March 31, 2022
• First Posted (Actual): April 8, 2022

Study Record Updates

• Last Update Posted (Actual): June 12, 2025
• Last Update Submitted That Met QC Criteria: June 9, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: virtual reality; college students
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: HSC-SPH-21-0935

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No