Stress-physiology Coherence, Interoception, and Well-being Following Mindfulness Training or Tracking Time Spent on Mobile Device (SCIM)

December 20, 2022 updated by: University of Wisconsin, Madison

Is Knowing the Body Knowing the Mind? Stress-physiology Coherence, Interoception, and Mindfulness

Chronic stress has been shown to impact long-term emotional and physical health. When nearly three-quarters of Americans report stress at levels that exceed what they consider healthy, there is a desperate need to understand factors that contribute to effective stress regulation. This work seeks to develop a measure tied to awareness and acceptance of stress that has shown promise as a predictor of multiple markers of mental and physical well-being, understand how it relates to awareness of the body, and explore whether it can be trained to alleviate suffering and promote well-being. This study aims to 1) Conceptually replicate and extend previous findings linking greater stress-physiology coherence to higher well-being. 2) Assess whether awareness of physiology is associated with stress-physiology coherence. 3) Explore whether stress-physiology coherence can be trained through a brief mindfulness training intervention.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Wisconsin
      • Madison, Wisconsin, United States, 53703
        • University Of Wisconsin - Madison

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age 18 to 65;
  2. Comfortable reading, writing, and conversing in English
  3. U.S. Citizen or permanent resident (for payment purposes)
  4. Have a smartphone compatible with our study app

Exclusion Criteria:

  1. Significant past experience with meditation, yoga, tai chi, or qi gong;
  2. Current or past psychotic disorder, Bipolar Disorder, PTSD, or social phobia;
  3. Current, severe major depressive episode;
  4. Current, severe generalized anxiety;
  5. Active prescription stimulant use (current or in the past month);
  6. Active prescription beta-blocker, beta-agonist, anti-high blood pressure, or anti-anxiety medication use (current or in the past month);
  7. Currently pregnant (due to physiological changes);
  8. History of neurological disorder;
  9. Currently diagnosed with high blood pressure, or heart murmur;
  10. Have a pacemaker
  11. Have participated in the Trier Social Stress Test previously

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mindfulness training
Participants will listen to one to two 3-30 minute audio recordings each day for 4 weeks between study visits (28 days total) through the Healthy Minds @Work smartphone app and record when they listen to each recording on a paper log. The app will also collect data on which recordings, when, and for how long participants listen.
Behavioral: Mindfulness training
Brief audio recordings discussing mindfulness or guided mindfulness practices.
Other Names:
  • Mindfulness, contemplative, meditation
Active Comparator: Tracking time spent on mobile device
Participants will record how much time they estimate they have spent on their phone in the past 24 hours, each day for 4 weeks (28 days total) between study visits.
Behavioral: Tracking time spent on mobile device
Participants will record each day how much time they estimate they spent on their smart phone in the past 24 hours.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in subjective stress-heart rate coherence
Time Frame: Baseline and post-test, separated by 4 weeks
Within-participant association between repeated measures of subjective stress (1-100 Visual Analog Scale rating) and heart rate over the course of a stress-induction paradigm. Stronger positive associations indicate higher stress-heart rate coherence.
Baseline and post-test, separated by 4 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Change in Accuracy on Method of Constant Stimuli (MCS) Interoceptive Accuracy Task
Time Frame: Baseline and post-test, separated by 4 weeks
Participants will complete a modified version of the MCS heart beat detection task used by Brener, Ring, and Liu. Participants will be asked to report whether a series of five tones are simultaneous with five of their heart beats. Each trial involves five heart beats. Each heart beat is followed by a tone, and the lag between heart beat and tone is varied across trials with five delay conditions: 0 ms, 100 ms, 200 ms, 300 ms, 400 ms, or 500 ms. Thus, each trial involves five beat-tone pairs, separated according to a single delay condition. Delays will be pseudorandomly presented across trials. Varying delays allow for individual differences in when participants perceive their heart beat. A continuous measure of judgement precision is defined as the participant's interquartile range (IQR) of the distribution of percent of simultaneous responses for each delay condition. IQR ranges from 0 to 450. Lower IQRs indicate more consistent responses and thus higher accuracy.
Baseline and post-test, separated by 4 weeks
Mean Change in Interoceptive Sensibility measured as the total score on the Multidimensional Assessment of Interoceptive Awareness Version 2 (MAIA-2)
Time Frame: Baseline and post-test, separated by 4 weeks
Interoceptive Sensibility measured as the total score on the Multidimensional Assessment of Interoceptive Awareness Version 2. Scores range from 0 to 185. Higher scores indicate greater interoceptive sensibility.
Baseline and post-test, separated by 4 weeks
Mean Change in Meta-Awareness Measured on a Method of Constant Stimuli Light-Tone Task
Time Frame: Baseline and post-test, separated by 4 weeks
Participants will complete a Method of Constant Stimuli (MCS) light-tone task. Participants will be asked to report whether a series of five tones are simultaneous with five light flashes. Each trial involves five light-tone pairs. Each light flash is followed by a tone, and the lag between light flash and tone is varied across trials with five delay conditions: 0 ms, 100 ms, 200 ms, 300 ms, 400 ms, or 500 ms. Thus, each trial involves five light-tone pairs, separated according to a single delay condition. Delays will be pseudorandomly presented across trials. After each trial in the task, participants will be asked how confident they are in their response on a simple likert scale ranging from 1 = not at all confident to 4 = completely confident. Meta-awareness is defined as the correlation between accurate responses (simultaneous judgements at the 0 ms delay) and confidence ratings. Scores thus range from -1 to 1. Higher scores indicate more meta-awareness.
Baseline and post-test, separated by 4 weeks
Mean Change in Total (Sum) Score on the Cognitive Fusion Questionnaire (CFQ)
Time Frame: Baseline and post-test, separated by 4 weeks
Cognitive Fusion Questionnaire (CFQ) total (sum) score. Scores range from 7-49. Greater numbers reflect greater cognitive fusion.
Baseline and post-test, separated by 4 weeks
Mean Change in Internal Locus of Control Subscale Total (Sum) Score of the Locus of Control (LOC)
Time Frame: Baseline and post-test, separated by 4 weeks
Internal locus of control subscale total (sum) score of the Locus of Control (LOC). Scores range from 0-48 on this subscale. Higher scores indicate greater internal locus of control.
Baseline and post-test, separated by 4 weeks
Mean Change in Total (Sum) Score on Psychological Well Being Scale (42-item version)
Time Frame: Baseline and post-test, separated by 4 weeks
Total score (sum) on Psychological Well Being Scale (42-item version). Scores range from 42 to 294. Higher scores indicate higher psychological well-being.
Baseline and post-test, separated by 4 weeks
Mean Change in Total (Sum) Score on the Brief Experiential Avoidance Questionnaire (BEAQ)
Time Frame: Baseline and post-test, separated by 4 weeks
Brief Experiential Avoidance Questionnaire (BEAQ) total (sum) score. Scores ranger from 15 to 90. Higher scores indicate greater experiential avoidance.
Baseline and post-test, separated by 4 weeks
Mean Change in Acceptance Subscale Total (Sum) Score of the COPE Questionnaire
Time Frame: Baseline and post-test, separated by 4 weeks
Acceptance subscale total (sum) score of the COPE questionnaire. Scores range from 4 to 16. Higher scores indicate more use of acceptance coping.
Baseline and post-test, separated by 4 weeks
Mean Change in Denial Subscale Total (Sum) Score of the COPE Questionnaire
Time Frame: Baseline and post-test, separated by 4 weeks
Denial subscale total (sum) score of the COPE questionnaire. Scores range from 4 to 16. Higher scores indicate more use of denial coping.
Baseline and post-test, separated by 4 weeks
Mean Change in Total (Sum) Score on Center for Epidemiological Studies Depression Inventory - Revised 20-item (CESD-R-20)
Time Frame: Baseline and post-test, separated by 4 weeks
Total score (sum) on Center for Epidemiological Studies Depression Inventory - Revised 20-item. Scores range from 0 to 60, with higher scores indicating more depressive symptoms.
Baseline and post-test, separated by 4 weeks
Mean Change in Total (Sum) Score on Spielberger Trait Anxiety Inventory Y2
Time Frame: Baseline and post-test, separated by 4 weeks
Total (Sum) Score on Spielberger Trait Anxiety Inventory Y2. Scores range from 20-80. Higher scores indicate greater trait anxiety.
Baseline and post-test, separated by 4 weeks
Mean Change in Global Score on Pittsburgh Sleep Quality Index (PSQI)
Time Frame: Baseline and post-test, separated by 4 weeks
Global score on Pittsburgh Sleep Quality Index (PSQI). Global scores range from 0 to 21. Higher scores indicate worse sleep quality.
Baseline and post-test, separated by 4 weeks
Mean Change in Total (Sum) Score on Perceived Stress Scale-10 (PSS-10)
Time Frame: Baseline and post-test, separated by 4 weeks
Total (sum) score on Perceived Stress Scale-10 (PSS-10). Scores range from 0 to 40. Higher scores indicating higher perceived stress.
Baseline and post-test, separated by 4 weeks
Mean Change in Nonjudging of Inner Experience Subscale Total (Sum) Score on the Five Facet Mindfulness Questionnaire (FFMQ)
Time Frame: Baseline and post-test, separated by 4 weeks
Nonjudging of Inner Experience Subscale Total (Sum) Score on the Five Facet Mindfulness Questionnaire (FFMQ). Scores on this subscale range from 8-40. Higher scores indicate greater nonjudging of inner experience.
Baseline and post-test, separated by 4 weeks
Mean Change in Observing Subscale Total (Sum) Score on the Five Facet Mindfulness Questionnaire (FFMQ)
Time Frame: Baseline and post-test, separated by 4 weeks
Observing Subscale Total (Sum) Score on the Five Facet Mindfulness Questionnaire (FFMQ). Scores on this subscale range from 8-40. Higher scores indicate greater observing of experience.
Baseline and post-test, separated by 4 weeks
Mean Change in Self-Awareness Subscale Total (Sum) Score on the Emotional Styles Questionnaire (ESQ)
Time Frame: Baseline and post-test, separated by 4 weeks
Self-Awareness Subscale Total (Sum) Score on the Emotional Styles Questionnaire (ESQ). Scores on this subscale range from 4-28. Higher scores indicate greater self-awareness.
Baseline and post-test, separated by 4 weeks
Mean Change in Difficulty Identifying Feelings Subscale Total (Sum) Score on the Toronto Alexithymia Scale (TAS-20)
Time Frame: Baseline and post-test, separated by 4 weeks
Difficulty Identifying Feelings Subscale Total (Sum) Score on the Toronto Alexithymia Scale (TAS-20; Bagby, Parker, & Taylor, 1994). Scores range from 20-60. Greater scores indicate stronger alexithymia.
Baseline and post-test, separated by 4 weeks
Mean Change in Incremental Mindset Total (Average) Score on the Dweck Mindset Instrument (DWI)
Time Frame: Baseline and post-test, separated by 4 weeks
Scores range from 1 to 6. Lower scores indicate more fixed/entity views of intelligence and talent. Higher scores indicate more incremental/malleable views of intelligence and talent.
Baseline and post-test, separated by 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Wisconsin, Madison

Collaborators

Mind and Life Institute, Hadley, Massachusetts

Investigators

  • Principal Investigator: Sasha Sommerfeldt, M.S., University of Wisconsin, Madison

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 21, 2020

Primary Completion (Actual)

November 30, 2022

Study Completion (Actual)

November 30, 2022

Study Registration Dates

First Submitted

September 5, 2019

First Submitted That Met QC Criteria

October 10, 2019

First Posted (Actual)

October 14, 2019

Study Record Updates

Last Update Posted (Estimate)

December 21, 2022

Last Update Submitted That Met QC Criteria

December 20, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • 2019-0153
  • A487400 (Other Identifier: UW Madison)
  • L&S/PSYCHOLOGY/PSYCHOLOGY (Other Identifier: UW Madison)
  • Protocol Version 6/10/2022 (Other Identifier: UW Madison)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Coded data only may be banked for future use to address research questions not included in this registration.

We may share coded data with other researchers within and outside of UW-Madison, and data may also be used in additional future approved research studies. These studies may include analysis of the information from this study alone or in combination with data collected in other studies.

All data except Protected Health Information may be shared. Data may be shared as Supplemental Information uploaded to a journal website and/or shared on a UW data sharing website. Data sharing would not require any further participation from participants. Participants may withdraw their data from future research by submitting a request in writing to our study team.

IPD Sharing Time Frame

Data will become available after Sasha Sommerfeldt's dissertation defense. The study protocol, analysis plan, informed consent form, and analytic code will be shared publicly through the open science framework upon acceptance of a manuscript detailing findings for the main aims of the study. Data will be shared upon request from qualified researchers.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Analytic Code

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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