Mindfulness Training and Respiration Biosignal Feedback - Study 1

Equa Health

Status: Completed

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

Treatments: Behavioral: Mindfulness Meditation

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT06625697

11744 (Registry Identifier)

1R44MH134709-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 18 to 30 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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80 participants in 1 patient group

Respiration Biosignal Feedback Condition

Experimental group

Description:

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.

Treatment:

Behavioral: Mindfulness Meditation