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Completed SBIR-STTR RPGS NIH (US)

A scalable intervention for stress management practices

$2.94M USD

Funder NATIONAL CENTER FOR COMPLEMENTARY & INTEGRATIVE HEALTH
Recipient Organization Livotion Llc
Country United States
Start Date Sep 17, 2024
End Date Aug 31, 2025
Duration 348 days
Number of Grantees 1
Roles Principal Investigator
Data Source NIH (US)
Grant ID 10922374
Grant Description

Roughly 60% of college students meet the criteria for at least one mental health disorder, with anxiety and depression being the most common diagnoses. The number of students seeking help for mental health issues increased by almost 40% at campus counseling centers between 2009 and 2015 and has continued to rise since

the onset of the COVID-19 pandemic, yet the demand has not been proportionately matched with increased funding to support mental health provision on college campuses. Thus, college students require a different approach to managing the stress that exacerbates their mental health symptoms. Technology-based breathing

interventions for stress management, which have been shown to prevent and remediate stress, are growing in popularity with the rise of commercially available mobile apps and bio-feedback technologies that do not require the help of a professional. However, while such mHealth interventions are now widely available, they often fail

because they do not lend themselves to use in real-world settings. Most technology-based interventions require the use of mobile phones ─ a disruptive and often unwelcome behavior in most educational settings. Existing biofeedback devices (e.g., chest straps, clip-ons, inhalers) are similarly contextually inappropriate, making use

obvious, distracting, and potentially stigmatizing. To overcome these barriers, the PI developed the AIRpen, a simple, affordable, multi-functional stress management device that is designed to fit into the fabric of users’ lives

to potentially optimize the delivery, practice, and fidelity of diaphragmatic breathing (DB) interventions in realworld settings. With anecdotal and empirical evidence supporting the device as feasible and acceptable in realworld academic settings (Purdue IRB-2022-423), this Phase I STTR project proposes the following aims: Aim 1.

Develop and refine the AIRpen intervention to enable the use of the device without oversight by a professional. Aim 2: Develop Smart AIRpen prototypes, which are equipped with sensors to measure user adherence in future real-world effectiveness studies. Aim 3: Establish the usability and acceptability of the AIRpen intervention with

a sample of 60 college students (30 in each device group) in a laboratory setting and gather preliminary feedback on subject-reported stress using physiological and subjective surveys as a secondary outcome. Aim 4: Establish the feasibility of a future real-world research study that will evaluate the usability and acceptability of the AIRpen

intervention when used during an exam period with a sample of 30 college students. Secondary outcome data utilizing subject-reported stress measures will also be collected. Results will support future larger-scale effectiveness trials and inform future protocol designs for scaling cost-effective and time-efficient treatments that

broadly support the development of coping skills for stress management.

All Grantees

Livotion Llc

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