Pilot Study of Virtual Reality Therapy for Students With Anxiety
Primary Purpose
Anxiety
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
gameChange
Sponsored by
About this trial
This is an interventional treatment trial for Anxiety focused on measuring virtual reality, college students
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
Sites / Locations
- The University of Texas Health Science Center at HoustonRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
gameChange
Arm Description
Outcomes
Primary Outcome Measures
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.
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.
Change in anxiety related behaviors such as rate of speech
Anxiety-related behaviors will be recorded using an event sampling observation guide
Change in anxiety related behaviors such as volume of speech
Anxiety-related behaviors will be recorded using an event sampling observation guide
Change in anxiety related behaviors such as Negative self-talk
Anxiety-related behaviors will be recorded using an event sampling observation guide
Change in anxiety related behaviors such as Utterances about experience
Anxiety-related behaviors will be recorded using an event sampling observation guide
Change in anxiety related behaviors such as Laughter
Anxiety-related behaviors will be recorded using an event sampling observation guide
Change in Psychomotor agitation such as pacing
Anxiety-related behaviors will be recorded using an event sampling observation guide
Change in Psychomotor agitation such as Fidgeting
Anxiety-related behaviors will be recorded using an event sampling observation guide
Change in Psychomotor agitation such as Rubbing hands/neck/head
Anxiety-related behaviors will be recorded using an event sampling observation guide
Change in physiology such as perspiration
Anxiety-related behaviors will be recorded using an event sampling observation guide
Secondary Outcome Measures
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
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
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
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.
Full Information
NCT ID
NCT05319509
First Posted
March 31, 2022
Last Updated
May 10, 2023
Sponsor
The University of Texas Health Science Center, Houston
1. Study Identification
Unique Protocol Identification Number
NCT05319509
Brief Title
Pilot Study of Virtual Reality Therapy for Students With Anxiety
Official Title
Pilot Study of Virtual Reality Therapy for Students With Anxiety
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
April 1, 2024 (Anticipated)
Study Completion Date
August 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety
Keywords
virtual reality, college students
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
gameChange
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
gameChange
Intervention Description
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 Outcome Measure Information:
Title
Change in state anxiety as assessed by the Liebowitz Social Anxiety Scale-Self Report version (LSAS-SR)
Description
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.
Time Frame
before first session in week 1, before third session in week 2 and before sixth session in week 3
Title
Change in depressive symptoms as assessed by score on the Patient Health Questionnaire-4 (PHQ-4)
Description
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.
Time Frame
Baseline(before the first session in week 1)
Title
Change in anxiety related behaviors such as rate of speech
Description
Anxiety-related behaviors will be recorded using an event sampling observation guide
Time Frame
Week 1(session1 and session 2), week 2( session 3 and session 4), week 3 (session 5 and session 6)
Title
Change in anxiety related behaviors such as volume of speech
Description
Anxiety-related behaviors will be recorded using an event sampling observation guide
Time Frame
Week 1(session1 and session 2), week 2( session 3 and session 4), week 3 (session 5 and session 6)
Title
Change in anxiety related behaviors such as Negative self-talk
Description
Anxiety-related behaviors will be recorded using an event sampling observation guide
Time Frame
Week 1(session1 and session 2), week 2( session 3 and session 4), week 3 (session 5 and session 6)
Title
Change in anxiety related behaviors such as Utterances about experience
Description
Anxiety-related behaviors will be recorded using an event sampling observation guide
Time Frame
Week 1(session1 and session 2), week 2( session 3 and session 4), week 3 (session 5 and session 6)
Title
Change in anxiety related behaviors such as Laughter
Description
Anxiety-related behaviors will be recorded using an event sampling observation guide
Time Frame
Week 1(session1 and session 2), week 2( session 3 and session 4), week 3 (session 5 and session 6)
Title
Change in Psychomotor agitation such as pacing
Description
Anxiety-related behaviors will be recorded using an event sampling observation guide
Time Frame
Week 1(session1 and session 2), week 2( session 3 and session 4), week 3 (session 5 and session 6)
Title
Change in Psychomotor agitation such as Fidgeting
Description
Anxiety-related behaviors will be recorded using an event sampling observation guide
Time Frame
Week 1(session1 and session 2), week 2( session 3 and session 4), week 3 (session 5 and session 6)
Title
Change in Psychomotor agitation such as Rubbing hands/neck/head
Description
Anxiety-related behaviors will be recorded using an event sampling observation guide
Time Frame
Week 1(session1 and session 2), week 2( session 3 and session 4), week 3 (session 5 and session 6)
Title
Change in physiology such as perspiration
Description
Anxiety-related behaviors will be recorded using an event sampling observation guide
Time Frame
Week 1(session1 and session 2), week 2( session 3 and session 4), week 3 (session 5 and session 6)
Secondary Outcome Measure Information:
Title
Change in self-reported academic performance as assessed by the Motivated Strategies for Learning Questionnaire (MSLQ)
Description
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
Time Frame
before first session in week 1, before third session in week 2 and before sixth session in week 3
Title
change in feasibility as assessed by the rating on a short questionnaire
Description
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
Time Frame
after the third session in week 2 , after sixth session in week 3
Title
Change in acceptability as assessed by the rating on a short questionnaire
Description
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
Time Frame
after the third session in week 2 , after sixth session in week 3
Title
Change in perceived presence in the virtual environment (as indicated by continuous score on the Igroup Presence Questionnaire (IPQ)
Description
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.
Time Frame
after the third session in week 2 and the sixth session in week 3
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tsai Jack, PhD
Phone
210-276-9022
Email
Jack.Tsai@uth.tmc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Abigail Lipe
Phone
210-722-8218
Email
Abigail.R.Lipe@uth.tmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tsai Jack, PhD
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tsai Jack, PhD
Phone
210-276-9022
Email
Jack.Tsai@uth.tmc.edu
First Name & Middle Initial & Last Name & Degree
Abigail Lipe
Phone
210-722-8218
Email
Abigail.R.Lipe@uth.tmc.edu
12. IPD Sharing Statement
Plan to Share IPD
No
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Pilot Study of Virtual Reality Therapy for Students With Anxiety
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