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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04125758
Acronym
SCIM
Enrollment
120
Registered
2019-10-14
Start date
2020-01-21
Completion date
2022-11-30
Last updated
2022-12-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Not Seeking to Treat Any Conditions

Brief summary

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.

Interventions

BEHAVIORALMindfulness training

Brief audio recordings discussing mindfulness or guided mindfulness practices.

BEHAVIORALTracking 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.

Sponsors

Mind and Life Institute, Hadley, Massachusetts
CollaboratorOTHER
University of Wisconsin, Madison
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Investigator, Outcomes Assessor)

Masking description

Researchers involved in participant testing will not know the participant's group. Researchers conducting data analysis will not know data codes assigned to groups.

Intervention model description

Participants are randomly assigned after a baseline testing to either a mindfulness intervention or control group.

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change in subjective stress-heart rate coherenceBaseline and post-test, separated by 4 weeksWithin-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

MeasureTime frameDescription
Mean Change in Total (Sum) Score on Psychological Well Being Scale (42-item version)Baseline and post-test, separated by 4 weeksTotal score (sum) on Psychological Well Being Scale (42-item version). Scores range from 42 to 294. Higher scores indicate higher psychological well-being.
Mean Change in Accuracy on Method of Constant Stimuli (MCS) Interoceptive Accuracy TaskBaseline and post-test, separated by 4 weeksParticipants 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.
Mean Change in Interoceptive Sensibility measured as the total score on the Multidimensional Assessment of Interoceptive Awareness Version 2 (MAIA-2)Baseline and post-test, separated by 4 weeksInteroceptive 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.
Mean Change in Meta-Awareness Measured on a Method of Constant Stimuli Light-Tone TaskBaseline and post-test, separated by 4 weeksParticipants 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.
Mean Change in Total (Sum) Score on the Cognitive Fusion Questionnaire (CFQ)Baseline and post-test, separated by 4 weeksCognitive Fusion Questionnaire (CFQ) total (sum) score. Scores range from 7-49. Greater numbers reflect greater cognitive fusion.
Mean Change in Total (Sum) Score on the Brief Experiential Avoidance Questionnaire (BEAQ)Baseline and post-test, separated by 4 weeksBrief Experiential Avoidance Questionnaire (BEAQ) total (sum) score. Scores ranger from 15 to 90. Higher scores indicate greater experiential avoidance.
Mean Change in Acceptance Subscale Total (Sum) Score of the COPE QuestionnaireBaseline and post-test, separated by 4 weeksAcceptance subscale total (sum) score of the COPE questionnaire. Scores range from 4 to 16. Higher scores indicate more use of acceptance coping.
Mean Change in Denial Subscale Total (Sum) Score of the COPE QuestionnaireBaseline and post-test, separated by 4 weeksDenial subscale total (sum) score of the COPE questionnaire. Scores range from 4 to 16. Higher scores indicate more use of denial coping.
Mean Change in Internal Locus of Control Subscale Total (Sum) Score of the Locus of Control (LOC)Baseline and post-test, separated by 4 weeksInternal 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.
Mean Change in Total (Sum) Score on Spielberger Trait Anxiety Inventory Y2Baseline and post-test, separated by 4 weeksTotal (Sum) Score on Spielberger Trait Anxiety Inventory Y2. Scores range from 20-80. Higher scores indicate greater trait anxiety.
Mean Change in Global Score on Pittsburgh Sleep Quality Index (PSQI)Baseline and post-test, separated by 4 weeksGlobal score on Pittsburgh Sleep Quality Index (PSQI). Global scores range from 0 to 21. Higher scores indicate worse sleep quality.
Mean Change in Total (Sum) Score on Perceived Stress Scale-10 (PSS-10)Baseline and post-test, separated by 4 weeksTotal (sum) score on Perceived Stress Scale-10 (PSS-10). Scores range from 0 to 40. Higher scores indicating higher perceived stress.
Mean Change in Nonjudging of Inner Experience Subscale Total (Sum) Score on the Five Facet Mindfulness Questionnaire (FFMQ)Baseline and post-test, separated by 4 weeksNonjudging 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.
Mean Change in Observing Subscale Total (Sum) Score on the Five Facet Mindfulness Questionnaire (FFMQ)Baseline and post-test, separated by 4 weeksObserving 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.
Mean Change in Self-Awareness Subscale Total (Sum) Score on the Emotional Styles Questionnaire (ESQ)Baseline and post-test, separated by 4 weeksSelf-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.
Mean Change in Difficulty Identifying Feelings Subscale Total (Sum) Score on the Toronto Alexithymia Scale (TAS-20)Baseline and post-test, separated by 4 weeksDifficulty 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.
Mean Change in Incremental Mindset Total (Average) Score on the Dweck Mindset Instrument (DWI)Baseline and post-test, separated by 4 weeksScores 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.
Mean Change in Total (Sum) Score on Center for Epidemiological Studies Depression Inventory - Revised 20-item (CESD-R-20)Baseline and post-test, separated by 4 weeksTotal 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026