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

NCT04125758 | Completed

• 4 other identifiers: 2019-0153A487400L&S/PSYCHOLOGY/PSYCHOLOGYProtocol Version 6/10/2022
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Not Seeking to Treat Any Conditions

Outcome Measures

Primary Outcomes (1)

• 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

Other Outcomes (18)

• Mean Change in Accuracy on Method of Constant Stimuli (MCS) Interoceptive Accuracy Task

  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)

  Baseline and post-test, separated by 4 weeks

• Mean Change in Meta-Awareness Measured on a Method of Constant Stimuli Light-Tone Task

  Baseline and post-test, separated by 4 weeks

Study Arms (2)

Mindfulness training

EXPERIMENTAL

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

Tracking time spent on mobile device

ACTIVE COMPARATOR

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

Interventions

Mindfulness training BEHAVIORAL

Brief audio recordings discussing mindfulness or guided mindfulness practices.

Also known as: Mindfulness, contemplative, meditation

Mindfulness training

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.

Tracking time spent on mobile device

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• Mind and Life Institute, Hadley, Massachusetts: collaborator

Study Sites (1)

University of Wisconsin - Madison

Madison, Wisconsin, 53703, United States

Location

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MeSH Terms

Interventions

Mindfulness; Meditation

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Relaxation Therapy

Study Officials

• Sasha Sommerfeldt, M.S.

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Researchers involved in participant testing will not know the participant's group. Researchers conducting data analysis will not know data codes assigned to groups.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: September 5, 2019
• First Posted: October 14, 2019
• Study Start: January 21, 2020
• Primary Completion: November 30, 2022
• Study Completion: November 30, 2022
• Last Updated: December 21, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• 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.

Locations

US (1)