Authors: Janet Fason, Jeffrey Gudin, Peter Hurwitz.
Anxiety chronically affects 49.9% of all US adults aged 18-24, 32.3% of all US adults, and an estimated 4% of the global population currently experience an anxiety disorder. Nonpharmacologic, behavioral therapies are useful yet underutilized. Treatment with antidepressants and anxiolytics are the most common pharmacotherapy for anxiety disorders, with variable effectiveness, significant side-effect burden [including being implicated with suicide] and high misuse liability. Identifying alternative treatments, including non-invasive and non-pharmacologic options that are safe, efficacious, and have reduced or limited side effect profiles would be preferred over conventional therapies targeting anxiety-related symptoms.
Ongoing research suggests that brain patterns can be altered in response to various haptic stimuli. A novel patch that delivers haptic vibrotactile trigger technology (VTT) was designed and theorized to target various neural pathways to influence brain centers. The technology is over-the-counter, non-invasive, non-pharmacological and applied topically.
The purpose of this IRB-approved, blinded, minimal-risk observational study was to evaluate and compare patients’ experiences, perceptions and response for those who received a haptic vibrotactile trigger technology (VTT) embedded stress and anxiety-relieving patch (PEACE Patch with VTT; Super Patch Company, Srysty Holding Co, Toronto, Canada) with those who received a control patch without the embedded technology.
Methods: A total of 65 patients (49 females, 16 males) at 3 US investigator sites who presented with stress and/or anxiety- related issues or associated symptoms were enrolled in the treatment (n=65) arm of the study and completed baseline, day 7, and day 14 surveys. Demographic results were similar for gender and age at the baseline survey. The mean age at baseline was 46.8 years. The study evaluated changes in stress and anxiety symptoms, mental health perceptions and other relevant domains via validated stress and anxiety measurement and symptom scales (e.g., The Perceived Stress Scale (PSS) and the Medical Outcomes Study Short Form20 (SF-20)) as well as additional survey questions regarding patient satisfaction, patient quality of life, change in medication usage, change in other treatment modalities attempted, and any side effects reported during the study period.
Results: After using the VTT embedded stress and anxiety-relieving patch, results showed statistically significant decreases in stress and anxiety related symptoms, improved mental health scores, and improved perceptions about overall health. At day 14, over 90% of patients in the treatment group indicated that they were satisfied with the patch and approximately 90% of subjects indicated that they would recommend it to others for the treatment of anxiety related symptoms.
Conclusions: Study results indicate that this non- harmacologic, non-invasive, haptic vibrotactile trigger technology (VTT) embedded topical patch reduces stress and anxiety levels, improves mental health perceptions, and may encourage initiation and incorporation of exercise and other concomitant behavioral activities. These results suggest that further investigation is warranted, and may support the use of this OTC patch as a first-line, noninvasive and nonpharmacological therapy and also as a component of the multimodal treatment approach to anxiety and related symptoms.
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