Anxiety Clinical Trial
Official title:
Pilot Study of Virtual Reality Therapy for Students With Anxiety
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | The University of Texas Health Science Center at Houston | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
The University of Texas Health Science Center, Houston |
United States,
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 |
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