Pilot Study of Virtual Reality Therapy for Students With Anxiety

NCT05319509 | Recruiting FDA Device

• 1 other identifier: HSC-SPH-21-0935
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Keywords

virtual reality; college students

Outcome Measures

Primary Outcomes (11)

• 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 Outcomes (4)

• Change in self-reported academic performance as assessed by the Motivated Strategies for Learning Questionnaire (MSLQ)

  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

  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

  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)

  after the third session in week 2 and the sixth session in week 3

Study Arms (1)

gameChange

EXPERIMENTAL

Device: gameChange

Interventions

gameChange DEVICE

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.

gameChange

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Tsai Jack, PhD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tsai Jack, PhD

CONTACT

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

Abigail Lipe

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 31, 2022
• First Posted: April 8, 2022
• Study Start: April 1, 2022
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: June 12, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)