Mindfulness Training and Respiration Biosignal Feedback - Study 2
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Mindfulness Meditation, Mindfulness Meditation with Respiration Feedback Chart and Predictive Mindfulness Skill Scores.
- Who it may be relevant to
- Registry conditions: Psychological Distress, Mindfulness Skills, Usability Satisfaction. Basic parameters: 18 years — 30 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Behavioral Mindfulness Meditation
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 through - Behavioral Mindfulness Meditation with Respiration Feedback Chart and Predictive Mindfulness Skill Scores
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 th
Primary outcome measures
- 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)]
Secondary outcome measures (7)
- 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]
Eligibility criteria
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 be randomized to one of two conditions
- Willing to provide ratings on their training experience
Exclusion criteria
- Currently pregnant
- Current or previous diagnosis with psychosis or schizophrenia
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Sequential
- Masking
- Double blind
- Primary purpose
- Basic science
Study locations
United States · 1 center
- GATF Building — Pittsburgh
Identifiers
NCT: NCT07136948 · 1R44MH134709-01A1 · 1R44MH134709-01A1