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Recruiting NCT05319509

Pilot Study of Virtual Reality Therapy for Students With Anxiety

No phase Interventional Anxiety

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: gameChange.
Who it may be relevant to
Registry conditions: Anxiety. Basic parameters: 18 years — 30 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

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]
  • 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)]
  • 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)]
  • 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)]
  • 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)]
  • 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)]
  • 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)]
  • 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)]
  • 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)]
  • 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)]
Secondary outcome measures (4)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • The University of Texas Health Science Center at Houston — Houston

Identifiers

NCT: NCT05319509 · HSC-SPH-21-0935

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗