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NCT Number: NCT05319509

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.

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Key information

Conditions

Anxiety Anxiety Disorders Mental Disorders

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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

  4. 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

  5. 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

  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)

    Anxiety-related behaviors will be recorded using an event sampling observation guide

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

Secondary outcomes

  1. 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

    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

  2. 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

    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

  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

    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

  4. 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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Abigail Lipe

CONTACT

[email protected]

210-722-8218

Tsai Jack, PhD

CONTACT

[email protected]

210-276-9022

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Apr 8, 2022
Registry last updated
Jun 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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