Psychological DistressNCT06625697
Mindfulness Training and Respiration Biosignal Feedback - Study 1
A study testing Mindfulness Meditation in people with Psychological Distress and Develop a Respiration Biosignal Feedback Algorithm, run by Equa Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Psychological Distress, Develop a Respiration Biosignal Feedback Algorithm, Utilize Respiration Algorithm to Predict Mindfulness Skills
- What is being tested?
- Mindfulness Meditation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2024to 8 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Currently pregnant
- Current or previous diagnosis with psychosis or schizophrenia
Trial locations and contacts
1 site in 1 country.
United States1 site
GATF Building, 4615 Forbes Avenue
Pittsburgh, Pennsylvania, 15213
About this study
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:
Read more
- 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
Read the 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.
- Conditions
- Psychological Distress, Develop a Respiration Biosignal Feedback Algorithm, Utilize Respiration Algorithm to Predict Mindfulness Skills
- Being tested
- Mindfulness Meditation
- Keywords
- respiration biosignal feedback, young adults, mental health, well-being, mindfulness skills, psychological distress
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness MeditationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Mindfulness Meditation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From enrollment to the end of treatment at up to week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2024
- Study start1 May 2024
- Primary completion8 Aug 2025
- Study completion8 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychological DistressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Equa Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Worcester Polytechnic Institute, National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, David Creswell, Equa Health
- Investigators
- David Creswell, PhD, Principal investigator, Equa Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06625697
- Sponsor's protocol ID
- 11744
- Other IDs
- 1R44MH134709-01A1
- Status last verified
- Aug 2025
- First submitted
- 25 Sep 2024
- Last updated
- 19 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness Training and Respiration Biosignal Feedback - Study 1
- ClinicalTrials.gov ID
- NCT06625697
- Acronym / sponsor ID
- 11744
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Equa HealthIndustry (pharma, biotech, devices)
- Collaborators
- Worcester Polytechnic Institute, National Institute of Mental Health (NIMH)
- Study start
- 1 May 2024 (actual)
- Primary completion
- 8 Aug 2025 (actual)
- Study completion
- 8 Aug 2025 (actual)
- First posted
- 3 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Respiration Biosignal Feedback Condition | Experimental | Behavioral: Mindfulness MeditationParticipants 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. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (2 listed)
- Currently pregnant
- Current or previous diagnosis with psychosis or schizophrenia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness MeditationParticipants 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. | Behavioural | Respiration Biosignal Feedback Condition |
Primary outcome
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
Time frame: Same day, change from pre-mindfulness meditation training to post-mindfulness meditation 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.
9 secondary outcomes
User satisfaction with the mindfulness meditation app, Equa as assessed by the Systems User Satisfaction scale at post treatment
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: From enrollment to the end of treatment at up to week 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2025.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Creswell, PhD principal investigator
Equa Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness Meditation in people with Psychological Distress and Develop a Respiration Biosignal Feedback Algorithm, run by Equa Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Same day, change from pre-mindfulness meditation training to post-mindfulness meditation training). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2025.