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Completed

NCT Number: NCT04125758

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

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.

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Key information

Conditions

Not Seeking to Treat Any Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Wisconsin - Madison

Madison, Wisconsin, 53703, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Mindfulness Training

Behavioral

Brief audio recordings discussing mindfulness or guided mindfulness practices.

Other names: Mindfulness, contemplative, meditation

Tracking time spent on mobile device

Behavioral

Participants will record each day how much time they estimate they spent on their smart phone in the past 24 hours.

Primary outcomes

  1. 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.

Other outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. 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.

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

  • Mind and Life Institute, Hadley, Massachusetts

Registry information

Official study title

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

Acronym: SCIM

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Oct 14, 2019
Registry last updated
Dec 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.