Pilot Study of Virtual Reality Therapy for Students With Anxiety

Anxiety Clinical Trial

Official title:

Pilot Study of Virtual Reality Therapy for Students With Anxiety

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05319509
• Other study ID #: HSC-SPH-21-0935
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2022
• Est. completion date: August 1, 2027

Study information

• Verified date: May 2024
• Source: The University of Texas Health Science Center, Houston
• Contact: Tsai Jack, PhD
• Phone: 210-276-9022
• Email: Jack.Tsai[@]uth.tmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 of three weeks) for reducing anxiety symptoms in college students.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: August 1, 2027
• Est. primary completion date: April 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders

Intervention

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.

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	before first session in week 1, before third session in week 2 and before sixth session in week 3
Primary	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.	Baseline(before the first session in week 1)
Primary	Change in anxiety related behaviors such as rate of speech	Anxiety-related behaviors will be recorded using an event sampling observation guide	Week 1(session1 and session 2), week 2( session 3 and session 4), week 3 (session 5 and session 6)
Primary	Change in anxiety related behaviors such as volume of speech	Anxiety-related behaviors will be recorded using an event sampling observation guide	Week 1(session1 and session 2), week 2( session 3 and session 4), week 3 (session 5 and session 6)
Primary	Change in anxiety related behaviors such as Negative self-talk	Anxiety-related behaviors will be recorded using an event sampling observation guide	Week 1(session1 and session 2), week 2( session 3 and session 4), week 3 (session 5 and session 6)
Primary	Change in anxiety related behaviors such as Utterances about experience	Anxiety-related behaviors will be recorded using an event sampling observation guide	Week 1(session1 and session 2), week 2( session 3 and session 4), week 3 (session 5 and session 6)
Primary	Change in anxiety related behaviors such as Laughter	Anxiety-related behaviors will be recorded using an event sampling observation guide	Week 1(session1 and session 2), week 2( session 3 and session 4), week 3 (session 5 and session 6)
Primary	Change in Psychomotor agitation such as pacing	Anxiety-related behaviors will be recorded using an event sampling observation guide	Week 1(session1 and session 2), week 2( session 3 and session 4), week 3 (session 5 and session 6)
Primary	Change in Psychomotor agitation such as Fidgeting	Anxiety-related behaviors will be recorded using an event sampling observation guide	Week 1(session1 and session 2), week 2( session 3 and session 4), week 3 (session 5 and session 6)
Primary	Change in Psychomotor agitation such as Rubbing hands/neck/head	Anxiety-related behaviors will be recorded using an event sampling observation guide	Week 1(session1 and session 2), week 2( session 3 and session 4), week 3 (session 5 and session 6)
Primary	Change in physiology such as perspiration	Anxiety-related behaviors will be recorded using an event sampling observation guide	Week 1(session1 and session 2), week 2( session 3 and session 4), week 3 (session 5 and session 6)
Secondary	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	before first session in week 1, before third session in week 2 and before sixth session in week 3
Secondary	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	after the third session in week 2 , after sixth session in week 3
Secondary	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	after the third session in week 2 , after sixth session in week 3
Secondary	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.	after the third session in week 2 and the sixth session in week 3