Not Seeking to Treat Any Conditions Clinical Trial
— SCIMOfficial title:
Is Knowing the Body Knowing the Mind? Stress-physiology Coherence, Interoception, and Mindfulness
| Verified date | December 2022 |
| Source | University of Wisconsin, Madison |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 120 |
| Est. completion date | November 30, 2022 |
| Est. primary completion date | November 30, 2022 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 65 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | University of Wisconsin - Madison | Madison | Wisconsin |
| Lead Sponsor | Collaborator |
|---|---|
| University of Wisconsin, Madison | Mind and Life Institute, Hadley, Massachusetts |
United States,
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* Note: There are 28 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Mean Change in Accuracy on Method of Constant Stimuli (MCS) Interoceptive Accuracy Task | 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 | |
| Other | Mean Change in Interoceptive Sensibility measured as the total score on the Multidimensional Assessment of Interoceptive Awareness Version 2 (MAIA-2) | 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 | |
| Other | Mean Change in Meta-Awareness Measured on a Method of Constant Stimuli Light-Tone Task | 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 | |
| Other | Mean Change in Total (Sum) Score on the Cognitive Fusion Questionnaire (CFQ) | 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 | |
| Other | Mean Change in Internal Locus of Control Subscale Total (Sum) Score of the Locus of Control (LOC) | 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 | |
| Other | Mean Change in Total (Sum) Score on Psychological Well Being Scale (42-item version) | 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 | |
| Other | Mean Change in Total (Sum) Score on the Brief Experiential Avoidance Questionnaire (BEAQ) | 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 | |
| Other | Mean Change in Acceptance Subscale Total (Sum) Score of the COPE Questionnaire | 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 | |
| Other | Mean Change in Denial Subscale Total (Sum) Score of the COPE Questionnaire | 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 | |
| Other | Mean Change in Total (Sum) Score on Center for Epidemiological Studies Depression Inventory - Revised 20-item (CESD-R-20) | 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 | |
| Other | Mean Change in Total (Sum) Score on Spielberger Trait Anxiety Inventory Y2 | 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 | |
| Other | Mean Change in Global Score on Pittsburgh Sleep Quality Index (PSQI) | 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 | |
| Other | Mean Change in Total (Sum) Score on Perceived Stress Scale-10 (PSS-10) | 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 | |
| Other | Mean Change in Nonjudging of Inner Experience Subscale Total (Sum) Score on the Five Facet Mindfulness Questionnaire (FFMQ) | 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 | |
| Other | Mean Change in Observing Subscale Total (Sum) Score on the Five Facet Mindfulness Questionnaire (FFMQ) | 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 | |
| Other | Mean Change in Self-Awareness Subscale Total (Sum) Score on the Emotional Styles Questionnaire (ESQ) | 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 | |
| Other | Mean Change in Difficulty Identifying Feelings Subscale Total (Sum) Score on the Toronto Alexithymia Scale (TAS-20) | 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 | |
| Other | Mean Change in Incremental Mindset Total (Average) Score on the Dweck Mindset Instrument (DWI) | 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 | |
| Primary | Change in subjective stress-heart rate coherence | 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 |