Psychological DistressNCT07136948
Mindfulness Training and Respiration Biosignal Feedback - Study 2
A study testing Mindfulness Meditation and Mindfulness Meditation with Respiration Feedback Chart and Predictive Mindfulness Skill Scores in people with Psychological Distress and Mindfulness Skills, run by Equa Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Psychological Distress, Mindfulness Skills, Usability Satisfaction
- What is being tested?
- Mindfulness Meditation and Mindfulness Meditation with Respiration Feedback Chart and Predictive Mindfulness Skill Scores
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jul 2025to Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 be randomized to one of two conditions
- 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. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
GATF Building
Pittsburgh, Pennsylvania, 15213
Emily G Thomas, BA, 828-773-9584, emily.grace@equahealth.io
David Creswell, Ph.D., 412-535-3338, david@equahealth.io
About this study
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:
Read more
- 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
Read the detailed description
Investigators will recruit young adults to participate in a study to examine the usability and user satisfaction of respiration biosignal feedback during meditation through phone motion data and microphones within headphones. Interested participants will be screened on study inclusion/exclusion criteria: (1) aged 18-30 years, (2) interested in coming on site to complete 14 smartphone guided mindfulness meditation training units, (3) willing to be assigned to one of two conditions, (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 to understand potential changes in mindfulness before and after select lessons. 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.
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. The control group will not see the graph tracking their physiological responses.
- Being tested
- Mindfulness Meditation, Mindfulness Meditation with Respiration Feedback Chart and Predictive Mindfulness Skill Scores
- 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 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.
Mindfulness Meditation with Respiration Feedback Chart and Predictive Mindfulness Skill ScoresBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Mindfulness Meditation with Respiration Feedback Chart and Predictive Mindfulness Skill Scores |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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 (lower anxiety) and 3 indicates nearly every day (higher anxiety).
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 related to the severity of depression symptomology. Zero is equivalent to not at all (lower depression) and 3 indicates nearly every day (higher depression)
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 related to their feelings and emotions. One is equivalent to not at all and five indicates extremely. The scores on items 1, 3, 5, 9, 10, 12, 14, 16, 17, and 19 are added. Scores can range from 10 - 50, with higher scores representing higher levels of positive affect. The scores on items 2, 4, 6, 7, 8, 11, 13, 15, 18, and 20 are added. Scores can range from 10 - 50, with lower scores representing lower levels of negative affect.
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 related to mindfulness practices. Zero is equivalent to not at all and six indicates very much. A mean score of the 15 items is taken, a higher score indicates greater mindfulness and a lower score indicates lower mindfulness.
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. Scores are added and those ranging from 0-13 would be considered low stress. Scores ranging from 14-26 would be considered moderate stress and scores ranging from 27-40 would be considered high perceived stress.
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 related to loneliness and isolation described in each of the 20 statements using a 4-point scale that ranges from 1=never to 4=always. The scoring is continuous with items 1, 5, 6, 9, 10, 15, 16, 19, 20 are all reverse scored. A higher score indicates greater feelings of isolation and loneliness, while a lower score indicates lower feelings of isolation and loneliness.
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 posted22 Aug 2025
- Study start21 Jul 2025
- Primary completionAug 2026 (estimated)
- Study completionSep 2026 (estimated)
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
- Randomised
- Intervention model
- Sequential
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
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, Ph.D., Principal investigator, Equa Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07136948
- Sponsor's protocol ID
- 1R44MH134709-01A1
- Other IDs
- 1R44MH134709-01A1
- Status last verified
- Jul 2026
- First submitted
- 13 Aug 2025
- Last updated
- 20 Jul 2026
- 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 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness Training and Respiration Biosignal Feedback - Study 2
- ClinicalTrials.gov ID
- NCT07136948
- Acronym / sponsor ID
- 1R44MH134709-01A1
- Keywords
- respiration biosignal feedback, young adults, mental health, well-being, mindfulness skills, psychological distress
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Equa HealthIndustry (pharma, biotech, devices)
- Collaborators
- Worcester Polytechnic Institute, National Institute of Mental Health (NIMH)
- Study start
- 21 Jul 2025 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 22 Aug 2025 (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 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
Detailed description
Investigators will recruit young adults to participate in a study to examine the usability and user satisfaction of respiration biosignal feedback during meditation through phone motion data and microphones within headphones. Interested participants will be screened on study inclusion/exclusion criteria: (1) aged 18-30 years, (2) interested in coming on site to complete 14 smartphone guided mindfulness meditation training units, (3) willing to be assigned to one of two conditions, (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 to understand potential changes in mindfulness before and after select lessons. 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.
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. The control group will not see the graph tracking their physiological responses.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control Group, No Physiological Feedback | Active comparator | Behavioral: Mindfulness MeditationParticipants 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. |
| Experimental Group, Physiological Feedback | Experimental | Behavioral: Mindfulness Meditation with Respiration Feedback Chart and Predictive Mindfulness Skill ScoresFollowing 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. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 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 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. | Behavioural | Control Group, No Physiological Feedback |
| Mindfulness Meditation with Respiration Feedback Chart and Predictive Mindfulness Skill ScoresParticipants 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. | Behavioural | Experimental Group, Physiological Feedback |
Primary outcome
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
Time frame: Throughout 5 sessions over the course of 4 weeks (study completion)
>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.
7 secondary outcomes
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
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
- 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.
David Creswell, Ph.D. 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 and Mindfulness Meditation with Respiration Feedback Chart and Predictive Mindfulness Skill Scores in people with Psychological Distress and Mindfulness Skills, 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 7 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: looking for participants now, as of the sponsor's last update on 20 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emily G Thomas, BA (828-773-9584, emily.grace@equahealth.io), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Throughout 5 sessions over the course of 4 weeks (study completion)). 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 20 Jul 2026.