Mental StressNCT06567496
Effects of a Virtual Reality Intervention on Mental Health Outcomes and Academic Success in Physical Therapy Students
A study testing First Resort in people with Mental Stress and Anxiety, run by Belmont University at 1 site in United States.
Trial summary
Exploring the impact of a virtual reality program, First Resort on graduate physical therapy student wellness and academic success. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mental Stress, Anxiety, Depression
- What is being tested?
- First Resort
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Aug 2024to 15 May 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Physical Therapy students enrolled at a single university in the southern United States during the fall 2024 semester
- -
Who cannot join
- 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
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Effects of a Virtual Reality Intervention on Mental Health Outcomes and Academic Success in First Year Physical Therapy Students
Exploring the impact of a virtual reality program, First Resort on graduate physical therapy student wellness and academic success.
Read the 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
- Conditions
- Mental Stress, Anxiety, Depression, Satisfaction
- Being tested
- First Resort
- Medical subject headings
- Stress, Psychological, Anxiety Disorders, Depression, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
First ResortOther
Also called First
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 8 week First Resort virtual reality navigated through Meta Quest II headset devices Receives: Other: First Resort |
| Delayed experimental intervention group | Other | 8 week First Resort virtual reality navigated through Meta Quest II headset devices delayed by one semester Receives: Other: First Resort |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Health Questionnaire-8
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.
Measured: 8 weeks
General Anxiety Disorder-7
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.
Measured: 8 weeks
Perceived Stress Scale-10
Self-reported measure of global perceived stress. Minimum score of 0 indicating low perceived stress and maximum of 40 which high perceived stress.
Measured: 8 weeks
Client Satisfaction Questionnaire-8
Self-reported questionnaire assessing satisfaction with the intervention. Minimum score of 8 indicating low satisfaction and maximum of 32 which is very high satisfaction.
Measured: 8 weeks
Self-reported Cumulative Grade Point Average
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.
Measured: 8 weeks
Secondary outcomes (5)
Patient Health Questionnaire-2
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.
Measured: 8 weeks
General Anxiety Disorder-2
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.
Measured: 8 weeks
The exit survey included several questions about Life style factors
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.
Measured: 8 weeks
Qualitative feedback_Focus groups
Describe experience with study through open-ended questions informing discussion portion of the paper.
Measured: 8 weeks
Descriptive categorical
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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2024
- Study start16 Aug 2024
- Primary completion15 May 2025 (estimated)
- Study completion15 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Mental StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Mixed methods randomized controlled trial with a waitlist control group incorporating focus groups
- Masking
- None (open label)
- Enrolment
- 23 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Belmont University
- Sponsor type
- University, hospital or other
- Collaborators
- BehaVR LLC
- Responsible party
- Principal investigator, Sue Curfman, Belmont University
- Investigators
- Sue E Curfman, PT, DHSc, Principal investigator, Belmont University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06567496
- Sponsor's protocol ID
- BelmontU
- Status last verified
- Feb 2025
- First submitted
- 16 Aug 2024
- Last updated
- 7 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 31912989Bolinski 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.
PubMed 34029860Ma 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.
PubMed 36002363Macauley K, Plummer L. Prevalence and Predictors of Anxiety in Doctor of Physical Therapy Students. J Allied Health. 2017 Summer;46(2):e39-e41.
PubMed 28561872
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of a Virtual Reality Intervention on Mental Health Outcomes and Academic Success in First Year Physical Therapy Students
- ClinicalTrials.gov ID
- NCT06567496
- Acronym / sponsor ID
- BelmontU
- Conditions
- Mental Stress, Anxiety, Depression, Satisfaction
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 23 participants (estimated)
- Lead sponsor
- Belmont UniversityUniversity, hospital or other
- Collaborators
- BehaVR LLC
- Study start
- 16 Aug 2024 (actual)
- Primary completion
- 15 May 2025 (estimated)
- Study completion
- 15 May 2025 (estimated)
- First posted
- 22 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Exploring the impact of a virtual reality program, First Resort on graduate physical therapy student wellness and academic success.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Mixed methods randomized controlled trial with a waitlist control group incorporating focus groups
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: First Resort8 week First Resort virtual reality navigated through Meta Quest II headset devices |
| Delayed experimental intervention group | Other | Other: First Resort8 week First Resort virtual reality navigated through Meta Quest II headset devices delayed by one semester |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Physical Therapy students enrolled at a single university in the southern United States during the fall 2024 semester
- -
Key exclusion criteria (2 listed)
- 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
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| First ResortAlso: FirstFirst 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 | Delayed experimental intervention group, Intervention |
Primary outcome
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.
General Anxiety Disorder-7
Time frame: 8 weeks
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.
Perceived Stress Scale-10
Time frame: 8 weeks
Self-reported measure of global perceived stress. Minimum score of 0 indicating low perceived stress and maximum of 40 which high perceived stress.
Client Satisfaction Questionnaire-8
Time frame: 8 weeks
Self-reported questionnaire assessing satisfaction with the intervention. Minimum score of 8 indicating low satisfaction and maximum of 32 which is very high satisfaction.
Self-reported Cumulative Grade Point Average
Time frame: 8 weeks
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.
5 secondary outcomes
Patient Health Questionnaire-2
Time frame: 8 weeks
General Anxiety Disorder-2
Time frame: 8 weeks
The exit survey included several questions about Life style factors
Time frame: 8 weeks
Qualitative feedback_Focus groups
Time frame: 8 weeks
Descriptive categorical
Time frame: 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2025.
- Background: PubMed 31912989Hoying 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.
- Background: PubMed 34029860Bolinski 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.
- Background: PubMed 36002363Ma 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.
- Background: PubMed 28561872Macauley K, Plummer L. Prevalence and Predictors of Anxiety in Doctor of Physical Therapy Students. J Allied Health. 2017 Summer;46(2):e39-e41.
- A mental wellness game for Quest Virtual Reality. First Resort. (2022, November 28).Link provided by the sponsor.
- Stress, worry \& sadness. RealizedCareLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sue E Curfman, PT, DHSc principal investigator
Belmont University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing First Resort in people with Mental Stress and Anxiety, run by Belmont University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 7 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Health Questionnaire-8 (time frame: 8 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06567496, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2025.