Pilot Study of Virtual Reality Therapy for Students With Anxiety

Sponsor
The University of Texas Health Science Center, Houston (Other)
Overall Status
Recruiting
CT.gov ID
NCT05319509
Collaborator
(none)
100
1
1
12
8.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: gameChange
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Pilot Study of Virtual Reality Therapy for Students With Anxiety
Actual Study Start Date :
Apr 1, 2022
Anticipated Primary Completion Date :
Apr 1, 2023
Anticipated Study Completion Date :
Apr 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: gameChange

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.

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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.

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

Secondary Outcome Measures

  1. 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

  2. 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

  3. 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

  4. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 30 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 The University of Texas Health Science Center at Houston Houston Texas United States 77030

Sponsors and Collaborators

  • The University of Texas Health Science Center, Houston

Investigators

  • Principal Investigator: Tsai Jack, PhD, The University of Texas Health Science Center, Houston

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jack Tsai, Professor, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT05319509
Other Study ID Numbers:
  • HSC-SPH-21-0935
First Posted:
Apr 8, 2022
Last Update Posted:
Apr 13, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by Jack Tsai, Professor, The University of Texas Health Science Center, Houston
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 13, 2022