NCT05319509 · The University of Texas Health Science Center, Houston
Pilot Study of Virtual Reality Therapy for Students With Anxiety
What this study is about
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-effectiveness, 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.
View original scientific description
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.
Interventions
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.
Primary outcome measures
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
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.
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)
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.
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)
Anxiety-related behaviors will be recorded using an event sampling observation guide
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)
Anxiety-related behaviors will be recorded using an event sampling observation guide
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)
Anxiety-related behaviors will be recorded using an event sampling observation guide
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)
Anxiety-related behaviors will be recorded using an event sampling observation guide
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)
Anxiety-related behaviors will be recorded using an event sampling observation guide
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)
Anxiety-related behaviors will be recorded using an event sampling observation guide
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)
Anxiety-related behaviors will be recorded using an event sampling observation guide
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)
Anxiety-related behaviors will be recorded using an event sampling observation guide
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)
Anxiety-related behaviors will be recorded using an event sampling observation guide
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Houston, Texas
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 12, 2025 · Source of record for eligibility and locations