- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06567496
Effects of a Virtual Reality Intervention on Mental Health Outcomes and Academic Success in Physical Therapy Students
The Effects of a Virtual Reality Intervention on Mental Health Outcomes and Academic Success in First Year Physical Therapy Students
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study is exploring the impact of an 8-week virtual reality intervention among graduate physical therapy students. Self-report measures of anxiety, depression and stress will be collected pre/post to assess the impact of the virtual reality intervention.
Purpose:
- Determine if there is an impact of a virtual reality intervention on symptoms of anxiety, depression and stress levels in first year physical therapy doctoral students
- Explore correlations between performance, anxiety, depression, stress and First Resort use in first year physical therapy doctoral students
- Explore the feasibility of use of First Resort app in first year physical therapy doctoral students
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Tennessee
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Nashville, Tennessee, United States, 37212
- Belmont University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Physical Therapy students enrolled at a single university in the southern United States during the fall 2024 semester
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Exclusion Criteria:
Patient Health Questionnaire-8 score of 15 or more General Anxiety Disorder-7 score of 15 or more History of seizures History of motion sickness History of epilepsy History of balance impairment History of significant visual History of auditory impairment
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Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention
8 week First Resort virtual reality navigated through Meta Quest II headset devices
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First Resort is an 8-week, self-guided, at-home, virtual reality program designed to be navigated via Meta Quest II headset devices and will be used as an intervention.
Other Names:
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Other: Delayed experimental intervention group
8 week First Resort virtual reality navigated through Meta Quest II headset devices delayed by one semester
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First Resort is an 8-week, self-guided, at-home, virtual reality program designed to be navigated via Meta Quest II headset devices and will be used as an intervention.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient Health Questionnaire-8
Time Frame: 8 weeks
|
Self-reported questionnaire most frequently used worldwide for the screening and severity assessment of depression.
Minimum score of 0 indicating no or minimal depression and maximum of 24 which is severe depression.
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8 weeks
|
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General Anxiety Disorder-7
Time Frame: 8 weeks
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Self-reported questionnaire to measure or assess the severity of generalized anxiety disorder.
Minimum score of 0 indicating no or minimal anxiety and maximum of 21 which is severe anxiety.
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8 weeks
|
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Perceived Stress Scale-10
Time Frame: 8 weeks
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Self-reported measure of global perceived stress.
Minimum score of 0 indicating low perceived stress and maximum of 40 which high perceived stress.
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8 weeks
|
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Client Satisfaction Questionnaire-8
Time Frame: 8 weeks
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Self-reported questionnaire assessing satisfaction with the intervention.
Minimum score of 8 indicating low satisfaction and maximum of 32 which is very high satisfaction.
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8 weeks
|
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Self-reported Cumulative Grade Point Average
Time Frame: 8 weeks
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Participants self-report the overall semester grade point average.
0.0-4.0 with 0.0 indicating failure and 4.0 indicating all A's.
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8 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The exit survey included several questions about Life style factors
Time Frame: 8 weeks
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Participants will be asked about sleep and exercise behaviors throughout the study.
They will also be asked if they had mental health support during the study, such as counseling or psychiatric care.
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8 weeks
|
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Patient Health Questionnaire-2
Time Frame: 8 weeks
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Self-reported questionnaire most frequently used worldwide for the screening and severity assessment of depression.
Minimum score 0 indicating low likelihood depression and maximum of 6 which indicates positive screen for depression.
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8 weeks
|
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General Anxiety Disorder-2
Time Frame: 8 weeks
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Self-reported questionnaire to measure or assess the severity of generalized anxiety disorder.
Minimum score 0 indicating low likelihood of anxiety and maximum of 6 which indicates positive screen for anxiety.
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8 weeks
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Qualitative feedback_Focus groups
Time Frame: 8 weeks
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Describe experience with study through open-ended questions informing discussion portion of the paper.
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8 weeks
|
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Descriptive categorical
Time Frame: 8 weeks
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This is descriptive and categorical data delivered through Qualtrics using single choice from multiple categorical responses.
This included descriptive information about sleep, exercise habits, and other consults sought by participants.
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8 weeks
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Sue E Curfman, PT, DHSc, Belmont University
Publications and helpful links
General Publications
- Hoying J, Melnyk BM, Hutson E, Tan A. Prevalence and Correlates of Depression, Anxiety, Stress, Healthy Beliefs, and Lifestyle Behaviors in First-Year Graduate Health Sciences Students. Worldviews Evid Based Nurs. 2020 Feb;17(1):49-59. doi: 10.1111/wvn.12415. Epub 2020 Jan 8.
- Ma J, Zhao D, Xu N, Yang J. The effectiveness of immersive virtual reality (VR) based mindfulness training on improvement mental-health in adults: A narrative systematic review. Explore (NY). 2023 May-Jun;19(3):310-318. doi: 10.1016/j.explore.2022.08.001. Epub 2022 Aug 5.
- Bolinski F, Etzelmuller A, De Witte NAJ, van Beurden C, Debard G, Bonroy B, Cuijpers P, Riper H, Kleiboer A. Physiological and self-reported arousal in virtual reality versus face-to-face emotional activation and cognitive restructuring in university students: A crossover experimental study using wearable monitoring. Behav Res Ther. 2021 Jul;142:103877. doi: 10.1016/j.brat.2021.103877. Epub 2021 May 11.
- Macauley K, Plummer L. Prevalence and Predictors of Anxiety in Doctor of Physical Therapy Students. J Allied Health. 2017 Summer;46(2):e39-e41.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BelmontU
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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