Mindfulness Training and Respiration Biosignal Feedback - Study 1

NCT ID: NCT06625697

Last Updated: 2025-08-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-01

Study Completion Date

2025-08-08

Brief Summary

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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

Detailed Description

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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.

Conditions

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Psychological Distress Develop a Respiration Biosignal Feedback Algorithm Utilize Respiration Algorithm to Predict Mindfulness Skills

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Mindfulness Meditation

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Worcester Polytechnic Institute

OTHER

Sponsor Role collaborator

National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Equa Health

INDUSTRY

Sponsor Role lead

Responsible Party

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David Creswell

Co-Founder, Chief Science Officer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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David Creswell, PhD

Role: PRINCIPAL_INVESTIGATOR

Equa Health

Locations

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GATF Building, 4615 Forbes Avenue

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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1R44MH134709-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

11744

Identifier Type: -

Identifier Source: org_study_id

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