Mindfulness Training and Respiration Biosignal Feedback - Study 2

NCT07136948 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-08-22

No results posted yet for this study

Summary

The goal of this research is to test usability and user satisfaction with a new breathing feature on the meditation app, Equa, to help young adults who are distressed, understand their physiological responses and mindfulness skill development during meditation.

Our main aims are to test an algorithm that can use physiologic signals to give feedback about how participant physiology is changing during guided lessons on the meditation app, Equa through:

* Assessing user satisfaction and usability
* Measuring how much participant mindfulness skills are improving

Participants will:

* Complete a survey about demographics, their thoughts and feelings before and after the mindfulness meditation program
* Complete 14 smartphone guided mindfulness meditation training units while physiological measures are being recorded
* A subset of participants will see a graph tracking their physiological responses from the guided meditation lesson and predictive mindfulness skill scores
* Complete a few brief questionnaires before and after mindfulness practices to understand potential changes in their mindfulness skills

Conditions

  • Psychological Distress
  • Mindfulness Skills
  • Usability Satisfaction

Interventions

BEHAVIORAL

Mindfulness Meditation

Participants will be randomly assigned to one of two different 14-unit smartphone meditation program groups that involve completing a 2-10 minute daily guided practice on their phones. Participants in both groups will follow the same 14 units of mindfulness meditation curriculum that consists of learning and practicing techniques to improve concentration, sensory clarity, and equanimity (Equa meditation app) and have access to additional curriculum. Physiological measures will be tracked throughout the duration of lessons. The control group will not see the graph tracking their physiological responses or the predictive mindfulness skill scores based on the algorithm development.

BEHAVIORAL

Mindfulness Meditation with Respiration Feedback Chart and Predictive Mindfulness Skill Scores

Participants will then be randomly assigned to one of two different 14-unit smartphone meditation program groups that involve completing a 2-10 minute daily guided practice on their phones. Participants in both groups will follow the same 14 units of mindfulness meditation curriculum that consists of learning and practicing techniques to improve concentration, sensory clarity, and equanimity (Equa meditation app) and have access to additional curriculum. Physiological measures will be tracked throughout the duration of lessons. Following the guided meditation lessons, a subset of participants (the experimental group) will see a graph tracking their physiological responses from the guided meditation lesson and predictive mindfulness skill scores based on our algorithm development. The feedback chart is produced by the physiological measures tracked throughout the duration of the lesson, and is displayed within the Equa app, moments after the meditation lessons concludes.

Sponsors & Collaborators

  • Worcester Polytechnic Institute

    collaborator OTHER
  • National Institute of Mental Health (NIMH)

    collaborator NIH
  • Equa Health

    lead INDUSTRY

Principal Investigators

  • David Creswell, Ph.D. · Equa Health

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-21
Primary Completion
2025-11-30
Completion
2025-11-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07136948 on ClinicalTrials.gov