Clinical trial NCT05319509: 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
Overall status: RECRUITING
Phase: NA
Conditions: Anxiety
Keywords: virtual reality
college students
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2022-04-08
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in state anxiety as assessed by the Liebowitz Social Anxiety Scale-Self Report version (LSAS-SR)
timeFrame: before first session in week 1, before third session in week 2 and before sixth session in week 3
measure: Change in depressive symptoms as assessed by score on the Patient Health Questionnaire-4 (PHQ-4)
timeFrame: Baseline(before the first session in week 1)
measure: Change in anxiety related behaviors such as rate of speech
timeFrame: Week 1(session1 and session 2), week 2( session 3 and session 4), week 3 (session 5 and session 6)
measure: Change in anxiety related behaviors such as volume of speech
timeFrame: Week 1(session1 and session 2), week 2( session 3 and session 4), week 3 (session 5 and session 6)
measure: Change in anxiety related behaviors such as Negative self-talk
timeFrame: Week 1(session1 and session 2), week 2( session 3 and session 4), week 3 (session 5 and session 6)
measure: Change in anxiety related behaviors such as Utterances about experience
timeFrame: Week 1(session1 and session 2), week 2( session 3 and session 4), week 3 (session 5 and session 6)
measure: Change in anxiety related behaviors such as Laughter
timeFrame: Week 1(session1 and session 2), week 2( session 3 and session 4), week 3 (session 5 and session 6)
measure: Change in Psychomotor agitation such as pacing
timeFrame: Week 1(session1 and session 2), week 2( session 3 and session 4), week 3 (session 5 and session 6)
measure: Change in Psychomotor agitation such as Fidgeting
timeFrame: Week 1(session1 and session 2), week 2( session 3 and session 4), week 3 (session 5 and session 6)
measure: Change in Psychomotor agitation such as Rubbing hands/neck/head
timeFrame: Week 1(session1 and session 2), week 2( session 3 and session 4), week 3 (session 5 and session 6)
measure: Change in physiology such as perspiration
timeFrame: Week 1(session1 and session 2), week 2( session 3 and session 4), week 3 (session 5 and session 6)
Secondary outcomes:
measure: Change in self-reported academic performance as assessed by the Motivated Strategies for Learning Questionnaire (MSLQ)
timeFrame: before first session in week 1, before third session in week 2 and before sixth session in week 3
measure: change in feasibility as assessed by the rating on a short questionnaire
timeFrame: after the third session in week 2 , after sixth session in week 3
measure: Change in acceptability as assessed by the rating on a short questionnaire
timeFrame: after the third session in week 2 , after sixth session in week 3
measure: Change in perceived presence in the virtual environment (as indicated by continuous score on the Igroup Presence Questionnaire (IPQ)
timeFrame: after the third session in week 2 and the sixth session in week 3
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Tsai Jack, PhD
role: PRINCIPAL_INVESTIGATOR
References: