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

23 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment First Resort for stress and anxiety?

Research shows that virtual reality (VR) treatments can effectively reduce anxiety, as seen in studies where VR stress management protocols led to greater anxiety reduction compared to other methods. Additionally, VR has been found to be beneficial for anxiety disorders, with lower deterioration rates compared to those not receiving active treatment. ^{1 2 3 4 5}

Is virtual reality treatment for stress and anxiety safe for humans?

There is no specific safety data available for virtual reality treatment for stress and anxiety in the provided research articles. ^{6 7 8 9 10}

How does the treatment 'First Resort' using virtual reality differ from other treatments for stress and anxiety?

First Resort uses virtual reality to create immersive environments that help reduce stress and anxiety by providing controlled exposure to stressors in a safe setting. This method is unique because it combines the benefits of exposure therapy with the interactive and engaging nature of virtual reality, which can enhance the therapeutic experience and outcomes compared to traditional methods. ^{1 2 11 12 13}

What is the purpose of this trial?

Exploring the impact of a virtual reality program, First Resort on graduate physical therapy student wellness and academic success.

Research Team

Sue E Curfman, PT, DHSc

Principal Investigator

Belmont University

Eligibility Criteria

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

I have had issues with my balance.

Patient Health Questionnaire-8 score of 15 or more

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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]

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]

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]

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Virtual reality interventions for the treatment of anxiety disorders: A scoping review. [2023]

2. Austria pubmed.ncbi.nlm.nih.gov

Virtual reality biofeedback interventions for treating anxiety : A systematic review, meta-analysis and future perspective. [2022]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Why you really eat? Virtual reality in the treatment of obese emotional eaters. [2008]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Deterioration rates in Virtual Reality Therapy: An individual patient data level meta-analysis. [2020]

5. Netherlands 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. [2023]

6. United States 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. [2023]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Ambulatory care visits for treating adverse drug effects in the United States, 1995-2001. [2019]

8. Spain pubmed.ncbi.nlm.nih.gov

Adverse drug reactions. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

The need for expanded monitoring of adverse events in behavioral health clinical trials. [2012]

10. England pubmed.ncbi.nlm.nih.gov

Quantifying the risks of non-oncology phase I research in healthy volunteers: meta-analysis of phase I studies. [2018]

11. United States pubmed.ncbi.nlm.nih.gov

Review of Psychophysiological and Psychotherapeutic Studies of Stress Using Virtual Reality Technologies. [2023]

12. Switzerland pubmed.ncbi.nlm.nih.gov

Effect of Virtual Reality on Stress Reduction and Change of Physiological Parameters Including Heart Rate Variability in People With High Stress: An Open Randomized Crossover Trial. [2021]

13. Greece pubmed.ncbi.nlm.nih.gov

[Virtual reality therapy in anxiety disorders]. [2017]