Mindfulness training with respiration biosignal feedback
Mindfulness Training and Respiration Biosignal Feedback - Study 2
NA · Equa Health · NCT07136948
This project tests whether a breathing-signal feedback feature in the Equa meditation app helps distressed young adults improve mindfulness skills and find the app easy to use.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 30 Years |
| Sex | All |
| Sponsor | Equa Health (industry) |
| Locations | 1 site (Pittsburgh, Pennsylvania) |
| Trial ID | NCT07136948 on ClinicalTrials.gov |
What this trial studies
Young adults aged 18–30 who report psychological distress will be randomized to either standard guided mindfulness sessions in the Equa app or the same sessions plus a respiration biosignal feedback chart and predictive mindfulness-skill scores. Participants complete 14 smartphone-guided meditation lessons while physiological data (smartphone and earbud motion/microphone signals, Hexoskin shirt sensors, and heart rate) are recorded and brief questionnaires are completed before and after selected lessons. A subset of participants will view a graph of their physiological responses and model-derived mindfulness scores to test usability and satisfaction. Primary outcomes are user satisfaction and usability of the feedback feature and changes in self-reported mindfulness skills over the training period.
Who should consider this trial
Good fit: Ideal candidates are English-speaking adults aged 18–30 who are experiencing psychological distress, willing to be randomized, able to come on-site, and comfortable wearing earbud headphones and a sensor shirt during sessions.
Not a fit: People who are currently pregnant or have a current or prior diagnosis of psychosis or schizophrenia are excluded and would not benefit from participation, and individuals unwilling to wear sensors or attend on-site sessions are unlikely to benefit.
Why it matters
Potential benefit: If successful, the feature could help young adults better notice and track their breathing and mindfulness progress, making meditation training more engaging and easier to learn.
How similar studies have performed: Prior biofeedback and mindfulness studies have shown promising improvements in self-regulation and engagement, but combining smartphone/earbud respiration signals with Hexoskin shirt data and predictive 'skill' scores is a relatively novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Ages 18-30 years of Age * Fluent in English * Psychological distress * Willing to participate in guided meditation or stress management training. * Willing and able to wear earbud headphones and a shirt which uses sensors to track motion and physiological measures. * Willing to be randomized to one of two conditions * Willing to provide ratings on their training experience Exclusion Criteria: * Currently pregnant * Current or previous diagnosis with psychosis or schizophrenia
Where this trial is running
Pittsburgh, Pennsylvania
- GATF Building — Pittsburgh, Pennsylvania, United States (RECRUITING)
Study contacts
- Principal investigator: David Creswell, Ph.D. — Equa Health
- Study coordinator: Emily G Thomas, BA
- Email: emily.grace@equahealth.io
- Phone: 828-773-9584
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Psychological Distress, Mindfulness Skills, Usability Satisfaction, respiration biosignal feedback, young adults, mental health, well-being, mindfulness skills