Mindfulness Training and Respiration Biosignal Feedback - Study 1

NCT06625697 | Completed DMC

• 2 other identifiers: 117441R44MH134709-01A1
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• User satisfaction with the mindfulness meditation app, Equa as assessed by the Systems User Satisfaction scale at post treatment

  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

  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

  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

Study Arms (1)

Respiration Biosignal Feedback Condition

EXPERIMENTAL

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

Interventions

Mindfulness Meditation 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.

Respiration Biosignal Feedback Condition

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 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, 4615 Forbes Avenue

Pittsburgh, Pennsylvania, 15213, United States

Location

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, PhD

  Equa Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-Founder, Chief Science Officer

Study Record Dates

• First Submitted: September 25, 2024
• First Posted: October 3, 2024
• Study Start: May 1, 2024
• Primary Completion: August 8, 2025
• Study Completion: August 8, 2025
• Last Updated: August 19, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: We 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)