Clinical trial NCT04125758: Stress-physiology Coherence, Interoception, and Well-being Following Mindfulness Training or Tracking Time Spent on Mobile Device
Official title: Is Knowing the Body Knowing the Mind? Stress-physiology Coherence, Interoception, and Mindfulness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Not Seeking to Treat Any Conditions
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: Mind and Life Institute, Hadley, Massachusetts
First posted: 2019-10-14
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are randomly assigned after a baseline testing to either a mindfulness intervention or control group.
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in subjective stress-heart rate coherence
timeFrame: Baseline and post-test, separated by 4 weeks
Secondary outcomes:
Other outcomes:
measure: Mean Change in Accuracy on Method of Constant Stimuli (MCS) Interoceptive Accuracy Task
timeFrame: Baseline and post-test, separated by 4 weeks
measure: Mean Change in Interoceptive Sensibility measured as the total score on the Multidimensional Assessment of Interoceptive Awareness Version 2 (MAIA-2)
timeFrame: Baseline and post-test, separated by 4 weeks
measure: Mean Change in Meta-Awareness Measured on a Method of Constant Stimuli Light-Tone Task
timeFrame: Baseline and post-test, separated by 4 weeks
measure: Mean Change in Total (Sum) Score on the Cognitive Fusion Questionnaire (CFQ)
timeFrame: Baseline and post-test, separated by 4 weeks
measure: Mean Change in Internal Locus of Control Subscale Total (Sum) Score of the Locus of Control (LOC)
timeFrame: Baseline and post-test, separated by 4 weeks
measure: Mean Change in Total (Sum) Score on Psychological Well Being Scale (42-item version)
timeFrame: Baseline and post-test, separated by 4 weeks
measure: Mean Change in Total (Sum) Score on the Brief Experiential Avoidance Questionnaire (BEAQ)
timeFrame: Baseline and post-test, separated by 4 weeks
measure: Mean Change in Acceptance Subscale Total (Sum) Score of the COPE Questionnaire
timeFrame: Baseline and post-test, separated by 4 weeks
measure: Mean Change in Denial Subscale Total (Sum) Score of the COPE Questionnaire
timeFrame: Baseline and post-test, separated by 4 weeks
measure: Mean Change in Total (Sum) Score on Center for Epidemiological Studies Depression Inventory - Revised 20-item (CESD-R-20)
timeFrame: Baseline and post-test, separated by 4 weeks
measure: Mean Change in Total (Sum) Score on Spielberger Trait Anxiety Inventory Y2
timeFrame: Baseline and post-test, separated by 4 weeks
measure: Mean Change in Global Score on Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Baseline and post-test, separated by 4 weeks
measure: Mean Change in Total (Sum) Score on Perceived Stress Scale-10 (PSS-10)
timeFrame: Baseline and post-test, separated by 4 weeks
measure: Mean Change in Nonjudging of Inner Experience Subscale Total (Sum) Score on the Five Facet Mindfulness Questionnaire (FFMQ)
timeFrame: Baseline and post-test, separated by 4 weeks
measure: Mean Change in Observing Subscale Total (Sum) Score on the Five Facet Mindfulness Questionnaire (FFMQ)
timeFrame: Baseline and post-test, separated by 4 weeks
measure: Mean Change in Self-Awareness Subscale Total (Sum) Score on the Emotional Styles Questionnaire (ESQ)
timeFrame: Baseline and post-test, separated by 4 weeks
measure: Mean Change in Difficulty Identifying Feelings Subscale Total (Sum) Score on the Toronto Alexithymia Scale (TAS-20)
timeFrame: Baseline and post-test, separated by 4 weeks
measure: Mean Change in Incremental Mindset Total (Average) Score on the Dweck Mindset Instrument (DWI)
timeFrame: Baseline and post-test, separated by 4 weeks
Locations:
city: Madison
country: United States
facility: University of Wisconsin - Madison
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Sasha Sommerfeldt, M.S.
role: PRINCIPAL_INVESTIGATOR
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