Mindfulness Training and Respiration Biosignal Feedback - Study 2

NCT07136948 | Recruiting DMC

• 1 other identifier: 1R44MH134709-01A1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

respiration biosignal feedback; young adults; mental health; well-being; mindfulness skills; psychological distress

Outcome Measures

Primary Outcomes (1)

• Assess usability and user satisfaction with respiration biosignal tracking and predictive mindfulness skill scores during meditation training to changes in mindfulness skills from pre-training to post-training

  \>85 on System Usability Scale and significantly more user satisfaction with biosignal augmented Equa. The investigators will conduct usability testing with the respiration biosignal tracking on Equa, and experimentally evaluate if Equa-augmented respiration biosignal tracking increases user satisfaction in the lab relative to Equa with no biosignal tracking.

  Throughout 5 sessions over the course of 4 weeks (study completion)

Secondary Outcomes (7)

• Change from Baseline in total anxiety as assessed by the General Anxiety Disorder, 7-item questionnaire at post treatment

  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

  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

  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

  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

  From enrollment to the end of treatment at up to week 4

Study Arms (2)

Control Group, No Physiological Feedback

ACTIVE COMPARATOR

Participants 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. 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 the algorithm development. The control group will not see the graph tracking their physiology.

Behavioral: Mindfulness Meditation

Experimental Group, Physiological Feedback

EXPERIMENTAL

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 the 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.

Behavioral: Mindfulness Meditation with Respiration Feedback Chart and Predictive Mindfulness Skill Scores

Interventions

Mindfulness Meditation BEHAVIORAL

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.

Control Group, No Physiological Feedback

Mindfulness Meditation with Respiration Feedback Chart and Predictive Mindfulness Skill Scores BEHAVIORAL

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.

Experimental Group, Physiological Feedback

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Equa Health: lead
• Worcester Polytechnic Institute: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

GATF Building

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

MeSH Terms

Conditions

Psychological Well-Being

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• David Creswell, Ph.D.

  Equa Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emily G Thomas, BA

CONTACT

828-773-9584; emily.grace@equahealth.io

David Creswell, Ph.D.

CONTACT

4125353338; david@equahealth.io

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-Founder, Chief Science Officer

Model Details: The investigators will experimentally evaluate if Equa-augmented respiration biosignal tracking significantly increases user satisfaction relative to Equa with no biosignal tracking. Both groups will receive the 14 lessons of mindfulness meditation, however only one group (experimental) will see the respiration biosignal feedback from the algorithm developed and tested in Study 1.

Study Record Dates

• First Submitted: August 13, 2025
• First Posted: August 22, 2025
• Study Start: July 21, 2025
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: August 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: The investigators will provide data within six months of any approved request.
• 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.

Locations

US (1)