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Clinical Trials/NCT05319509
NCT05319509
Recruiting
N/A

Pilot Study of Virtual Reality Therapy for Students With Anxiety

The University of Texas Health Science Center, Houston1 site in 1 country100 target enrollmentApril 1, 2022
ConditionsAnxiety

Overview

Phase
N/A
Intervention
Not specified
Conditions
Anxiety
Sponsor
The University of Texas Health Science Center, Houston
Enrollment
100
Locations
1
Primary Endpoint
Change in anxiety related behaviors such as volume of speech
Status
Recruiting
Last Updated
10 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 1, 2022
End Date
August 1, 2027
Last Updated
10 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jack Tsai

Professor

The University of Texas Health Science Center, Houston

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

Outcomes

Primary Outcomes

Change in anxiety related behaviors such as volume of speech

Time Frame: 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

Time Frame: 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)

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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)

Time Frame: 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 anxiety related behaviors such as rate of speech

Time Frame: 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

Time Frame: 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

Time Frame: 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 physiology such as perspiration

Time Frame: 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 Outcomes

  • 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)
  • 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)
  • 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)
  • 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)

Study Sites (1)

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