Virtual Reality for Stress and Anxiety

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Belmont University

Disqualifiers: Seizures, Motion sickness, Epilepsy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a virtual reality program called First Resort to determine its effectiveness in helping physical therapy graduate students manage stress and anxiety and succeed in their studies. Participants will use a VR headset for eight weeks to engage with the program. Some will begin immediately, while others will wait a semester. The trial is suitable for physical therapy students at a specific university in the southern U.S. who do not experience severe anxiety, seizures, or motion sickness. As an unphased trial, it provides a unique opportunity for students to explore innovative stress management techniques.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this virtual reality program is safe for graduate physical therapy students?

A study of 61 people found that virtual reality treatment reduced anxiety by 34% and stress by 32%. Research has shown that virtual reality is a safe and popular method for managing stress and anxiety. This non-drug option is easy to use. No specific safety concerns have been reported for the First Resort program, suggesting it is likely well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard treatments for stress and anxiety, which often rely on medication and therapy sessions, the First Resort treatment uses virtual reality technology to provide a new approach. Researchers are excited about this treatment because it immerses users in calming, controlled environments via the Meta Quest II headset, potentially offering more engaging and immediate relief. This method is novel because it combines psychological techniques with cutting-edge technology, making it a unique and promising option for managing stress and anxiety.

What evidence suggests that the First Resort virtual reality program is effective for stress and anxiety?

Research has shown that virtual reality (VR) therapy, such as the First Resort program, can help reduce anxiety. Studies with individuals who have anxiety disorders have found that VR therapy improves anxiety symptoms. One study found that only 4% of anxiety patients using VR therapy experienced worsening symptoms, which is very encouraging. Additionally, VR therapy tends to keep participants more engaged and results in fewer dropouts compared to traditional methods. In this trial, participants will receive the First Resort VR therapy either immediately or after a delay of one semester. This suggests that First Resort could effectively help physical therapy students manage stress and anxiety. ^{1 6 7 8 9}

Who Is on the Research Team?

Sue E Curfman, PT, DHSc

Principal Investigator

Belmont University

Are You a Good Fit for This Trial?

This trial is for graduate physical therapy students who are experiencing stress, anxiety, or depression. It aims to see if a virtual reality program can improve their mental health and academic performance.

Inclusion Criteria

Physical Therapy students enrolled at a single university in the southern United States during the fall 2024 semester

Exclusion Criteria

History of auditory impairment

Patient Health Questionnaire-8 score of 15 or more

I have had issues with my balance.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo an 8-week virtual reality intervention using the First Resort program

8 weeks

Virtual sessions using Meta Quest II headset

Follow-up

Participants are monitored for mental health outcomes and academic success post-intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• First Resort

Trial Overview The intervention being tested is 'First Resort,' a virtual reality program designed to help with stress and mental well-being. The study will assess its effects on the participants' mental health outcomes and academic success.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

8 week First Resort virtual reality navigated through Meta Quest II headset devices

Group II: Delayed experimental intervention group Experimental Treatment 1 Intervention

8 week First Resort virtual reality navigated through Meta Quest II headset devices delayed by one semester

Who Is Running the Clinical Trial?

Belmont University

Lead Sponsor

Trials

4

Recruited

80+

BehaVR LLC

Industry Sponsor

Trials

5

Recruited

280+

Published Research Related to This Trial

Current clinical trials for behavioral health interventions often do not monitor adverse events as thoroughly as those for medications and medical devices, focusing mainly on serious incidents like suicide attempts and hospitalizations.

There is a need for expanded monitoring of adverse events in psychotherapy trials to better inform patients about potential risks, including temporary increases in anxiety, which are often overlooked but can impact treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The need for expanded monitoring of adverse events in behavioral health clinical trials. Peterson, AL., Roache, JD., Raj, J., et al.[2012]

Virtual reality (VR) biofeedback significantly reduces self-reported anxiety and heart rate in individuals, based on a systematic review of 7 studies involving 191 participants, including 5 randomized controlled trials.

While VR biofeedback showed promise in lowering anxiety and heart rate compared to waiting list controls, it did not demonstrate significant differences in outcomes when compared to traditional 2D biofeedback, indicating the need for further research in diverse populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual reality biofeedback interventions for treating anxiety : A systematic review, meta-analysis and future perspective. Kothgassner, OD., Goreis, A., Bauda, I., et al.[2022]

Virtual Reality (VR) interventions have been shown to significantly reduce symptoms of various anxiety disorders in adults, making them a promising alternative to traditional exposure therapy.

These VR treatments are generally well-accepted by clients and have minimal side effects, although caution is advised for Combat-Related PTSD in Vietnam veterans, indicating the need for further research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual reality interventions for the treatment of anxiety disorders: A scoping review. Andersen, NJ., Schwartzman, D., Martinez, C., et al.[2023]

Adverse drug reactions (ADRs) are significant contributors to health issues and increased healthcare costs, highlighting the need for effective monitoring systems.

Pharmacovigilance systems play a crucial role in identifying and preventing drug-related risks, particularly for newly marketed medications, but face challenges like under-reporting of ADRs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse drug reactions. Montané, E., Santesmases, J.[2021]

In 2001, there were approximately 4.3 million visits to healthcare facilities in the U.S. due to adverse drug events (VADEs), indicating a significant patient safety concern.

The study found that VADEs were more common in elderly patients aged 65-74 and in females, highlighting the need for targeted safety measures in these populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ambulatory care visits for treating adverse drug effects in the United States, 1995-2001. Zhan, C., Arispe, I., Kelley, E., et al.[2019]

Virtual reality exposure therapy (VRET) has emerged as a promising alternative for treating anxiety disorders, particularly in cases where traditional imaginal exposure therapy is challenging to implement, allowing for controlled exposure to phobic stimuli in a safe environment.

High levels of 'immersion' and 'presence' during VRET are linked to better therapeutic outcomes, enabling therapists to tailor exposure intensity to individual patient needs, although the technology requires specialized training and can have mild side effects like nausea or dizziness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Virtual reality therapy in anxiety disorders]. Mitrousia, V., Giotakos, O.[2017]

The study analyzed adverse event (AE) data from six randomized controlled trials involving schizophrenia treatments, highlighting that the absolute prevalence and expected duration of AEs provide a more comprehensive understanding of a drug's safety compared to just incidence rates.

Using a new metric to assess the drug-placebo difference in AE prevalence, the research found that some AEs not listed in the standard drug label significantly impacted drug tolerability, suggesting that including these metrics in drug labels could enhance safety signal detection and inform better treatment choices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Novel Method for Deriving Adverse Event Prevalence in Randomized Controlled Trials: Potential for Improved Understanding of Benefit-Risk Ratio and Application to Drug Labels. Piacentino, D., Ogirala, A., Lew, R., et al.[2023]

In a meta-analysis of 11,028 healthy participants across 394 non-oncology phase I studies, 63.7% experienced adverse events, but 85% of these were classified as mild, indicating a relatively safe profile for the study drugs.

Only 0.31% of participants experienced serious adverse events, with no deaths or life-threatening incidents reported, suggesting that while adverse events are common, they are mostly not severe.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quantifying the risks of non-oncology phase I research in healthy volunteers: meta-analysis of phase I studies. Emanuel, EJ., Bedarida, G., Macci, K., et al.[2018]

In a study involving 810 patients, Virtual Reality (VR) treatment for anxiety disorders showed a low deterioration rate of 4.0%, which is comparable to the 2.8% in active control conditions and significantly better than the 15% deterioration rate in waiting list (WL) controls.

The study found that socio-demographic factors did not significantly influence deterioration rates, except for marital status, where married individuals in the WL condition had a lower likelihood of deterioration, indicating that VR is a safe treatment option with similar outcomes to other therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Deterioration rates in Virtual Reality Therapy: An individual patient data level meta-analysis. Fernández-Álvarez, J., Rozental, A., Carlbring, P., et al.[2020]

A systematic review of 17 studies involving 827 participants found that virtual reality (VR) applications can significantly reduce anxiety symptoms compared to passive control groups, with a strong effect size of 1.29.

While VR applications showed a non-significant overall effect compared to conventional therapies, they provide a valuable treatment option, especially when traditional therapies are not available.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of virtual reality applications in the treatment of anxiety disorders: A systematic review and meta-analysis of randomized-controlled trials. Schröder, D., Wrona, KJ., Müller, F., et al.[2023]

Citations

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Effectiveness of virtual reality therapy in the treatment ... The current findings suggest that VR therapy interventions have a positive effect on improving the anxiety state of patients with anxiety disorders.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06567496

Effects of a Virtual Reality Intervention on Mental Health ... Explore correlations between performance, anxiety, depression, stress and First Resort use in first year physical therapy doctoral students; Explore the ...

3. withpower.com withpower.com/trial/phase-stress-psychological-7-2024-71146

Virtual Reality for Stress and Anxiety · Info for Participants In a study involving 810 patients, Virtual Reality (VR) treatment for anxiety disorders showed a low deterioration rate of 4.0%, which is comparable to the 2.8% ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0005791623000605

Impact of virtual reality applications in the treatment ... The objective is to evaluate the treatment effect of virtual reality applications in the treatment of anxiety disorders compared to conventional therapy.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12260462/

The Effectiveness of Virtual Reality–Based Mindfulness ... Meta-analyses demonstrate that VR interventions achieve higher engagement rates and lower dropout compared to traditional delivery methods; ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11323791/

Virtual Reality and Stress Management: A Systematic Review This review explores the use of virtual reality (VR) as a stress management solution, aiming to assess its viability and effectiveness in this context.

7. sciencedirect.com sciencedirect.com/science/article/pii/S0883944125001510

The impact of virtual reality interventions on stress and ... VR is feasible, well-accepted, and a safe non-pharmacological alternative to reduce stress and anxiety in ICU patients. However, larger trials with standardised ...

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37483756/

Virtual reality in the management of stress and anxiety ... A study of 61 people showed that virtual reality treatment in the metaverse reduced anxiety by 34% and stress by 32%.

9. journals.sagepub.com journals.sagepub.com/doi/full/10.1177/20552076241308703

The benefits and safety of a virtual reality intervention in ... We developed a virtual reality (VR) program delivering weeks of pain psychotherapy without psychotherapists, with a focus on minimizing the risk of motion ...