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.

Given the considerable prevalence, severity, and impact of stress among college students, the development of scalable stress-management programs that are cost-effective, time-efficient, and applicable to real-world academic settings is sorely needed. Here, we propose to further develop, evaluate, and refine scalable implementation materials and accurate measurement tools to support future real-world effectiveness studies of an affordable, technology-based breathing intervention. Results will solidify the feasibility, usability, and efficacy of a scalable intervention, the AIRpen, for potentially optimizing the delivery, practice, and fidelity of diaphragmatic breathing (DB) practices in real-world settings to improve students’ mental health.