Mindfulness Training and Respiration Biosignal Feedback - Study 1

The goal of this research is to develop 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 build an algorithm that can use physiologic signals to:

• Give feedback about how participant physiology is changing during guided lessons on the meditation app, Equa
• Measure 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
• Complete a few brief questionnaires before and after mindfulness practices to understand potential changes in their mindfulness skills

Study Overview

• Status: Completed
• Conditions: Psychological Distress; Develop a Respiration Biosignal Feedback Algorithm; Utilize Respiration Algorithm to Predict Mindfulness Skills
• Intervention / Treatment: Behavioral: Mindfulness Meditation

Detailed Description

Investigators will recruit young adults to participate in a study to examine the effectiveness of respiration dynamics during meditation through phone motion data and microphones within headphones. Interested participants who contact us will be screened on study inclusion/exclusion criteria: (1) aged 18-30 years, (3]2) interested in coming on site to complete 14 smartphone guided mindfulness meditation training units, (4) willing to wear physiological monitoring equipment and provide ratings of their training experience, (5) Not currently pregnant and (6) no current or previous diagnosis of psychosis or schizophrenia

Participants are told they are going to participate in a study that focuses on monitoring physiological responses during meditation. At the start of the study, participants will complete questions via an online survey focused on demographics, prior meditation experience, their thoughts and feelings as these may be informative to participants' meditation experience.

Participants will complete a few brief questionnaires before and after each mindfulness practices to understand potential changes in mindfulness . Participant physiological data will be recorded (E.g., heart rate) via smartphones and headphones to track physiologic dynamics. Additionally, the sensory shirt, made by Hexoskin Smart Sensors; AI, will also continuously measure physiologics via two inductive plethysmography (RIP) sensors. The Hexoskin shirt also tracks motion via a three-axis accelerometer. These measures will enable investigators to better understand mindfulness measures during meditation.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • GATF Building, 4615 Forbes Avenue

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 provide ratings on their training experience

Exclusion Criteria:

• Currently pregnant
• Current or previous diagnosis with psychosis or schizophrenia

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Respiration Biosignal Feedback Condition; Participants will complete guided seated Equa training lessons on a laboratory smartphone device while physiological measures are tracked. After training lessons, a respiration biosignal feedback chart will appear.

Behavioral: Mindfulness Meditation; Participants will be instructed on how to wear the physiological monitoring equipment during the 14-unit mindfulness meditation curriculum. Participants will then complete 2-10 minute guided seated Equa training lessons on a laboratory smartphone device while physiological measures are tracked. After training lessons, a respiration biosignal feedback chart will appear on the smartphone screen. Participants will also complete a brief mindfulness survey before and after training lessons.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Optimization of deep learning algorithms that correlate changes in respiration dynamics during meditation training to changes in mindfulness skills from pre-training to post-training	Prediction accuracy of greater than 90%. There are three distinct mindfulness skills that will be measured before and after trainings - Concentration, Sensory Clarity, and Equanimity. Participants will respond to a likert scale from one to five. One is equivalent to a poor perceived level of skill and five indicates an excellent perceived level of skill.	Same day, change from pre-mindfulness meditation training to post-mindfulness meditation training

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
User satisfaction with the mindfulness meditation app, Equa as assessed by the Systems User Satisfaction scale at post treatment	Participants respond to the usability of a system by indicating the degree to which they agree or disagree with 10 statements using a 5-point scale that ranges from 1 "Strongly Disagree" to 5 "Strongly Agree" to 4 always.	End of treatment session at up to week 4
User satisfaction with the mindfulness meditation app, Equa as assessed by the Mobile App Rating Scale at post treatment	The rating scale assesses app quality on four dimensions - Engagement, Functionality, Aesthetics, Information, and Subjective Quality. We are assessing Engagement and Subjective Quality only. All items are rated on a 5-point scale from "1.Inadequate" to "5.Excellent". Ratings for individual items are averaged within the applicable dimension.	At the end of treatment session at up to week 4
Change from Baseline in total anxiety as assessed by the General Anxiety Disorder, 7-item questionnaire at post treatment	Participants respond to a questionnaire asking about how often they have been bothered by any of the listed problems over the last 2 weeks. Zero is equivalent to not at all and 3 indicates nearly every day	From enrollment to the end of treatment at up to week 4
Change from Baseline in total depression as assessed by the Patient Health Questionnaire-9 at post treatment	Participants respond to a questionnaire asking about how often they have been bothered by any of the listed problems over the last 2 weeks. Zero is equivalent to not at all and 3 indicates nearly every day	From enrollment to the end of treatment at up to week 4
Change from Baseline in total affect as assessed by the Positive and Negative Affect Scale at post treatment	Participants respond to a questionnaire asking to indicate the extent they have felt the following ways over the past 2 weeks. One is equivalent to not at all and five indicates extremely.	from enrollment to the end of treatment at up to week 4
Change from Baseline in mean state mindfulness as assessed by the Mindful Attention Awareness Scale - state at post treatment	Participants respond to a questionnaire asking to what degree they were having each experience described over the past 2 weeks. Zero is equivalent to not at all and six indicates very much.	From enrollment to the end of treatment at up to week 4
Change from Baseline in total perceived stress as assessed by the Perceived Stress Scale at post treatment	Participants respond to a questionnaire asking about their feelings and thoughts over the past 2 weeks. Zero is equivalent to never and four indicates very often.	From enrollment to the end of treatment at up to week 4
Change from Baseline in total social well-being as assessed by the Satisfaction with Life Scale at post treatment	Participants indicate how much they agree or disagree with each of the 5 items using a 7-point scale that ranges from 7 strongly agree to 1 strongly disagree. A score of 5-9 indicates extreme dissatisfaction and a score of 31-35 indicates extreme satisfaction.	From enrollment to the end of treatment at up to week 4
Change from Baseline in total loneliness as assessed by the UCLA Loneliness scale at post treatment	Participants indicate how often they feel the way described in each of the 20 statements using a 4-point scale that ranges from 1never to 4 always. The scoring is continuous.	From enrollment to the end of treatment at up to week 4

Collaborators and Investigators

• Sponsor: Equa Health
• Collaborators: National Institute of Mental Health (NIMH); Worcester Polytechnic Institute
• Investigators: Principal Investigator: David Creswell, PhD, Equa Health

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2024
• Primary Completion (Actual): August 8, 2025
• Study Completion (Actual): August 8, 2025

Study Registration Dates

• First Submitted: September 25, 2024
• First Submitted That Met QC Criteria: October 1, 2024
• First Posted (Actual): October 3, 2024

Study Record Updates

• Last Update Posted (Actual): August 19, 2025
• Last Update Submitted That Met QC Criteria: August 18, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: mental health; well-being; young adults; psychological distress; respiration biosignal feedback; mindfulness skills
• Other Study ID Numbers: 11744 (DAIDS ES Registry Number); 1R44MH134709-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The research team will only share de-identified data from our studies that allows outside groups to independently validate our claims in our published scientific articles. All data and documentation will be de-identified and will be consistent with applicable laws and regulations.
• IPD Sharing Time Frame: We will provide data within six months of any approved request.
• IPD Sharing Access Criteria: Scientific groups who aim to validate our findings can make requests for data access. The study team agrees that the names and Institutions of persons either given or denied access to the data, and the bases for such decisions, will be summarized in the annual progress reports.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No