Feasibility of using a biofeedback device in mindfulness training - a pilot randomized controlled trial

Area of Science:

• Psychology
• Biomedical Engineering
• Digital Health

Background:

• College students experience high stress levels, impacting well-being.
• Wearable biofeedback devices offer potential stress management solutions, but evidence is scarce.
• Research on the feasibility and effectiveness of these devices is limited.

Purpose of the Study:

• To assess the feasibility of using a real-time respiratory biofeedback device for stress management in college students.
• To evaluate participant adherence to the biofeedback device.
• To examine collaboration with the device's developing company.

Main Methods:

• 39 college students with chronic stress were randomized into a mindfulness-only group or a group using a biofeedback device.
• Both groups received mindfulness meditation training over two weeks.
• Participant and company compliance, and company collaboration were assessed.

Main Results:

• Participant device adherence and company collaboration were low.
• All participants showed stress reduction, but no added benefit from the biofeedback device was observed.
• Group-by-time interaction effects were not significant, indicating no superior outcome for the biofeedback group.

Conclusions:

• The study's feasibility for larger-scale research was limited by low adherence and collaboration.
• The investigated biofeedback device provided no additional benefit over mindfulness alone.
• Open science collaborations are crucial for developing evidence-based regulations for rapidly evolving health technologies.