AnxietyNCT05319509
Pilot Study of Virtual Reality Therapy for Students With Anxiety
A study testing gameChange in people with Anxiety, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Anxiety
- What is being tested?
- gameChange
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2022to 1 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- Currently receiving psychological treatment for anxiety symptoms, or has received treatment in the last year.
- Report photosensitive epilepsy.
- Report stereoscopic vision or balance problems
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
Tsai Jack, PhD, 210-276-9022, Jack.Tsai@uth.tmc.edu
Abigail Lipe, 210-722-8218, Abigail.R.Lipe@uth.tmc.edu
About this study
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
- Being tested
- gameChange
- Keywords
- virtual reality, college students
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gameChangeDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| gameChange | Experimental | Not described Receives: Device: gameChange |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
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
Measured: 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
Measured: 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
Measured: 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.
Measured: after the third session in week 2 and the sixth session in week 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2022
- Study start1 Apr 2022
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jack Tsai, The University of Texas Health Science Center, Houston
- Investigators
- Tsai Jack, PhD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05319509
- Sponsor's protocol ID
- HSC-SPH-21-0935
- Status last verified
- Jun 2025
- First submitted
- 31 Mar 2022
- Last updated
- 12 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Virtual Reality Therapy for Students With Anxiety
- ClinicalTrials.gov ID
- NCT05319509
- Acronym / sponsor ID
- HSC-SPH-21-0935
- Conditions
- Anxiety
- Keywords
- virtual reality, college students
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 8 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| gameChange | Experimental | Device: gameChange |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (3 listed)
- Currently receiving psychological treatment for anxiety symptoms, or has received treatment in the last year.
- Report photosensitive epilepsy.
- Report stereoscopic vision or balance problems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| gameChangeStaff 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. | Device | gameChange |
Primary outcome
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
4 secondary outcomes
Change in self-reported academic performance as assessed by the Motivated Strategies for Learning Questionnaire (MSLQ)
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: after the third session in week 2 and the sixth session in week 3
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tsai Jack, PhD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing gameChange in people with Anxiety, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tsai Jack, PhD (210-276-9022, Jack.Tsai@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2025.