Menu
Recruiting NCT07127575

Scalable Intervention for Stress Management

No phase Interventional Stress Diaphragmatic Breathing

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Resistance Breathing Device, Electronic Resistance Breathing Device.
Who it may be relevant to
Registry conditions: Stress, Diaphragmatic Breathing. Basic parameters: 18 years — 30 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

A Scalable Intervention for Stress Management Practices

Overview

The purpose of this research is to measure the acceptance of a resistance breathing intervention and to assess whether it produces physiological and subjective effects in a laboratory setting.

Detailed description

College students experience a wide range of stressors during their studies, with many students experiencing levels of stress that can be clinically significant, such as anxiety or depression. Counseling centers on college campuses have seen a rise in students seeking mental health support or stress relief, but there exists a discrepancy in the level of need versus the support that can be provided. Stress management interventions, such as self-care mobile applications and devices, have risen in popularity given their relative accessibility and implementation of stress relieving interventions such as regulated breathing. Regulated breathing has been shown to be a reliable and effective form of stress relief, however its implementation within various eHealth interventions and related devices can come into conflict when used in educational settings. Mobile apps and biofeedback devices (e.g., chest straps, inhalers), can be contextually inappropriate, cumbersome, and potentially stigmatizing for students. 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 students' lives to potentially optimize the delivery, practice, and fidelity of diaphragmatic breathing (DB) interventions in real- world settings. With anecdotal and empirical evidence supporting the device as feasible and acceptable in real-world academic settings, this study will build upon prior work and measure the acceptance of the intervention and assess whether using the original and a "smart" version of the device as a stress relieving tool produces physiological and subjective effects in a laboratory setting.

Interventions

  • Device Resistance Breathing Device
    The AIRpen is a multifunctional stress management tool that helps users engage in diaphragmatic breathing at differing resistance levels, as well as other common stress relieving behaviors such as fidgeting
  • Device Electronic Resistance Breathing Device
    The Smart AIRpen functions just as the original AIRpen device and has been augmented with sensors to measure use patterns to determine whether the AIRpen is being used for fidgeting or breathing.

Primary outcome measures

  • Device Acceptability as Measured by the Acceptability of Intervention Measure (AIM) [Time frame: From enrollment to end of 1 hour study period.]
  • Device Usability as Measured by a Modified Version of the System Usability Scale (SUS) [Time frame: From enrollment until completion of 1 hour study period.]
Secondary outcome measures (2)
  • Perceived Stress as Measured by the Perceived Stress Scale (PSS_10) [Time frame: From enrollment to the end of the 1 hour study period]
  • Physiological Stress as Assessed with Heart Rate Monitoring [Time frame: From study enrollment to end of 1 hour study period]

Eligibility criteria

Inclusion criteria

  • Be at least 18 years old
  • Be currently enrolled in a college or university
  • Be able to read, speak, and comprehend English
  • Be able and willing to complete a 60-minute study involving heart rate monitoring, survey completion, training, a stress test, and device utilization

Exclusion criteria

-Individuals diagnosed with anxiety or stress and require professional support to cope with these clinical levels of stress or anxiety should not enroll in the study in place of professional assistance.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Purdue University — West Lafayette

Identifiers

NCT: NCT07127575 · IRB-2025-935 · 1R41AT012854-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗