Pilot Study of Virtual Reality Therapy for Students With Anxiety

Not Applicable

Recruiting

• Conditions: Anxiety

• Registration Number: NCT05319509
• Lead Sponsor: The University of Texas Health Science Center, Houston

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-03-31
• Study First Submitted QC: 2022-03-31
• Study Start: 2022-04-01
• Study First Posted: 2022-04-08
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-09
• Last Update Posted: 2025-06-12
• Primary Completion: 2027-04-01
• Study Completion: 2027-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change in anxiety related behaviors such as volume of speech	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	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 state anxiety as assessed by the Liebowitz Social Anxiety Scale-Self Report version (LSAS-SR)	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 anxiety related behaviors such as Utterances about experience	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	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	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 depressive symptoms as assessed by score on the Patient Health Questionnaire-4 (PHQ-4)	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 physiology such as perspiration	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 rate of speech	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	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	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 Outcome Measures

Name	Time	Method
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	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
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	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.
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	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
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	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

Trial Locations

Locations (1)

The University of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States