23 Participants Needed

Virtual Reality for Stress and Anxiety

Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Belmont University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

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.678910

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.12111213

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

SE

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
See 5 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
2Treatment groups
Experimental Treatment
Group I: InterventionExperimental Treatment1 Intervention
8 week First Resort virtual reality navigated through Meta Quest II headset devices
Group II: Delayed experimental intervention groupExperimental Treatment1 Intervention
8 week First Resort virtual reality navigated through Meta Quest II headset devices delayed by one semester

Find a Clinic Near You

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

References

Virtual reality interventions for the treatment of anxiety disorders: A scoping review. [2023]
Virtual reality biofeedback interventions for treating anxiety : A systematic review, meta-analysis and future perspective. [2022]
Why you really eat? Virtual reality in the treatment of obese emotional eaters. [2008]
Deterioration rates in Virtual Reality Therapy: An individual patient data level meta-analysis. [2020]
Impact of virtual reality applications in the treatment of anxiety disorders: A systematic review and meta-analysis of randomized-controlled trials. [2023]
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]
Ambulatory care visits for treating adverse drug effects in the United States, 1995-2001. [2019]
Adverse drug reactions. [2021]
The need for expanded monitoring of adverse events in behavioral health clinical trials. [2012]
Quantifying the risks of non-oncology phase I research in healthy volunteers: meta-analysis of phase I studies. [2018]
11.United Statespubmed.ncbi.nlm.nih.gov
Review of Psychophysiological and Psychotherapeutic Studies of Stress Using Virtual Reality Technologies. [2023]
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]
[Virtual reality therapy in anxiety disorders]. [2017]
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