Not Seeking to Treat Any ConditionsSCIMNCT04125758

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

A study testing Mindfulness training and Tracking time spent on mobile device in people with Not Seeking to Treat Any Conditions, run by University of Wisconsin, Madison at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Not Seeking to Treat Any Conditions
What is being tested?: Mindfulness training and Tracking time spent on mobile device
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 120 participants
Where: 1 siteUnited States
Study dates: 21 Jan 2020to 30 Nov 2022
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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);

Show all 11Show fewer

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

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Wisconsin - Madison
Madison, Wisconsin, 53703

Other trials in United States

About this study

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

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
Being tested: Mindfulness training, Tracking time spent on mobile device

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Mindfulness trainingBehavioural
Also called Mindfulness, contemplative, meditation
Brief audio recordings discussing mindfulness or guided mindfulness practices.
Tracking time spent on mobile deviceBehavioural
Participants will record each day how much time they estimate they spent on their smart phone in the past 24 hours.

Study groups in NCT04125758
Study group	Role	What they receive
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. Receives: 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. Receives: Behavioral: Tracking time spent on mobile device

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline and post-test, separated by 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Jan 202030 Nov 2022

First posted14 Oct 2019
Study start21 Jan 2020
Primary completion30 Nov 2022
Study completion30 Nov 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (28)Papers the sponsor has linked to this study.
Other trials for Not Seeking to Treat Any ConditionsStudies of the same condition, open and under way.
More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Model description: Participants are randomly assigned after a baseline testing to either a mindfulness intervention or control group.
Masking: Double blind
Who is masked: Investigator, Outcomes assessor
Enrolment: 120 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04125758
Sponsor's protocol ID: 2019-0153
Other IDs: A487400, L&S/PSYCHOLOGY/PSYCHOLOGY, Protocol Version 6/10/2022
Acronym: SCIM
Status last verified: Dec 2022
First submitted: 5 Sep 2019
Last updated: 21 Dec 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Coded data only may be banked for future use to address research questions not included in this registration. We may share coded data with other researchers within and outside of UW-Madison, and data may also be used in additional future approved research studies. These studies may include analysis of the information from this study alone or in combination with data collected in other studies. All data except Protected Health Information may be shared. Data may be shared as Supplemental Information uploaded to a journal website and/or shared on a UW data sharing website. Data sharing would not require any further participation from participants. Participants may withdraw their data from future research by submitting a request in writing to our study team.

Publications

Birkett MA. The Trier Social Stress Test protocol for inducing psychological stress. J Vis Exp. 2011 Oct 19;(56):3238. doi: 10.3791/3238.
PubMed 22042290
Ekman, P. (1992). An argument for basic emotions. Cognition & emotion, 6(3-4), 169-200.
Mauss IB, Levenson RW, McCarter L, Wilhelm FH, Gross JJ. The tie that binds? Coherence among emotion experience, behavior, and physiology. Emotion. 2005 Jun;5(2):175-90. doi: 10.1037/1528-3542.5.2.175.
PubMed 15982083
Campbell J, Ehlert U. Acute psychosocial stress: does the emotional stress response correspond with physiological responses? Psychoneuroendocrinology. 2012 Aug;37(8):1111-34. doi: 10.1016/j.psyneuen.2011.12.010. Epub 2012 Jan 18.
PubMed 22260938
Carver CS, Scheier MF, Weintraub JK. Assessing coping strategies: a theoretically based approach. J Pers Soc Psychol. 1989 Feb;56(2):267-83. doi: 10.1037//0022-3514.56.2.267.
PubMed 2926629
Darwin, C. (2009). The expression of the emotions in man and animals (P. Ekman, Ed.). Oxford, England: Oxford University Press. (Original work published 1872)
Garfinkel SN, Manassei MF, Hamilton-Fletcher G, In den Bosch Y, Critchley HD, Engels M. Interoceptive dimensions across cardiac and respiratory axes. Philos Trans R Soc Lond B Biol Sci. 2016 Nov 19;371(1708):20160014. doi: 10.1098/rstb.2016.0014. Epub 2016 Oct 10.
PubMed 28080971
Hirshberg MJ, Goldberg SB, Schaefer SM, Flook L, Findley D, Davidson RJ. Divergent effects of brief contemplative practices in response to an acute stressor: A randomized controlled trial of brief breath awareness, loving-kindness, gratitude or an attention control practice. PLoS One. 2018 Dec 12;13(12):e0207765. doi: 10.1371/journal.pone.0207765. eCollection 2018.
PubMed 30540772
Lang, P. J. (1988). What are the data of emotion? In V. Hamilton, G. H. Bower, & N. Frijda (Eds.), Cognitive perspectives on emotion and motivation (pp. 173-191). Amsterdam, The Netherlands: Martinus Nijhoff Publishers.
Lazarus, R. S. (1991). Emotion and adaptation. Oxford, England: Oxford University Press.
Levenson, R. W. (1994). Human emotion: A functional view. In P. Ekman & R. J. Davidson (Eds.), The nature of emotion: Fundamental questions (pp. 123-126). New York, NY: Oxford University Press.
Plutchik, R. (1980). Emotion: A psychoevolutionary synthesis. New York, NY: HarperCollins College Division.
Radloff, L. S. (1977). The CES-D scale: A self-report depression scale for research in the general population. Applied Psychology Measurement, 1, 385-401.
Ryff, C. D. (1989). Happiness is everything, or is it? Explorations on the meaning of psychological well-being. Journal of Personality and Social Psychology, 57, 1069-1081.
Sommerfeldt SL, Schaefer SM, Brauer M, Ryff CD, Davidson RJ. Individual Differences in the Association Between Subjective Stress and Heart Rate Are Related to Psychological and Physical Well-Being. Psychol Sci. 2019 Jul;30(7):1016-1029. doi: 10.1177/0956797619849555. Epub 2019 Jun 12.
PubMed 31188735

Study at a glance

From the registry record, last updated by the sponsor on 21 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Is Knowing the Body Knowing the Mind? Stress-physiology Coherence, Interoception, and Mindfulness
ClinicalTrials.gov ID: NCT04125758
Acronym / sponsor ID: SCIM / 2019-0153
Conditions: Not Seeking to Treat Any Conditions
Study type: Interventional
Recruitment status: Completed
Enrolment: 120 participants (actual)
Lead sponsor: University of Wisconsin, MadisonUniversity, hospital or other
Collaborators: Mind and Life Institute, Hadley, Massachusetts
Study start: 21 Jan 2020 (actual)
Primary completion: 30 Nov 2022 (actual)
Study completion: 30 Nov 2022 (actual)
First posted: 14 Oct 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (investigator, outcomes assessor)
Number of arms: 2
Model description: Participants are randomly assigned after a baseline testing to either a mindfulness intervention or control group.

Arm	Type	Receives
Mindfulness training	Experimental	Behavioral: Mindfulness trainingParticipants 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.
Tracking time spent on mobile device	Active comparator	Behavioral: Tracking time spent on mobile deviceParticipants 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.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (11 listed)

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);

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Mindfulness trainingAlso: Mindfulness, contemplative, meditationBrief audio recordings discussing mindfulness or guided mindfulness practices.	Behavioural	Mindfulness training
Tracking time spent on mobile deviceParticipants will record each day how much time they estimate they spent on their smart phone in the past 24 hours.	Behavioural	Tracking time spent on mobile device

Primary outcome

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.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2022.
Background: PubMed 22042290Birkett MA. The Trier Social Stress Test protocol for inducing psychological stress. J Vis Exp. 2011 Oct 19;(56):3238. doi: 10.3791/3238.
BackgroundEkman, P. (1992). An argument for basic emotions. Cognition & emotion, 6(3-4), 169-200.
Background: PubMed 15982083Mauss IB, Levenson RW, McCarter L, Wilhelm FH, Gross JJ. The tie that binds? Coherence among emotion experience, behavior, and physiology. Emotion. 2005 Jun;5(2):175-90. doi: 10.1037/1528-3542.5.2.175.
Background: PubMed 22260938Campbell J, Ehlert U. Acute psychosocial stress: does the emotional stress response correspond with physiological responses? Psychoneuroendocrinology. 2012 Aug;37(8):1111-34. doi: 10.1016/j.psyneuen.2011.12.010. Epub 2012 Jan 18.
Background: PubMed 2926629Carver CS, Scheier MF, Weintraub JK. Assessing coping strategies: a theoretically based approach. J Pers Soc Psychol. 1989 Feb;56(2):267-83. doi: 10.1037//0022-3514.56.2.267.
BackgroundDarwin, C. (2009). The expression of the emotions in man and animals (P. Ekman, Ed.). Oxford, England: Oxford University Press. (Original work published 1872)
Background: PubMed 28080971Garfinkel SN, Manassei MF, Hamilton-Fletcher G, In den Bosch Y, Critchley HD, Engels M. Interoceptive dimensions across cardiac and respiratory axes. Philos Trans R Soc Lond B Biol Sci. 2016 Nov 19;371(1708):20160014. doi: 10.1098/rstb.2016.0014. Epub 2016 Oct 10.
Background: PubMed 30540772Hirshberg MJ, Goldberg SB, Schaefer SM, Flook L, Findley D, Davidson RJ. Divergent effects of brief contemplative practices in response to an acute stressor: A randomized controlled trial of brief breath awareness, loving-kindness, gratitude or an attention control practice. PLoS One. 2018 Dec 12;13(12):e0207765. doi: 10.1371/journal.pone.0207765. eCollection 2018.
BackgroundLang, P. J. (1988). What are the data of emotion? In V. Hamilton, G. H. Bower, & N. Frijda (Eds.), Cognitive perspectives on emotion and motivation (pp. 173-191). Amsterdam, The Netherlands: Martinus Nijhoff Publishers.
BackgroundLazarus, R. S. (1991). Emotion and adaptation. Oxford, England: Oxford University Press.
BackgroundLevenson, R. W. (1994). Human emotion: A functional view. In P. Ekman & R. J. Davidson (Eds.), The nature of emotion: Fundamental questions (pp. 123-126). New York, NY: Oxford University Press.
BackgroundPlutchik, R. (1980). Emotion: A psychoevolutionary synthesis. New York, NY: HarperCollins College Division.
Individual participant dataSharing planned: Yes. Coded data only may be banked for future use to address research questions not included in this registration. We may share coded data with other researchers within and outside of UW-Madison, and data may also be used in additional future approved research studies. These studies may include analysis of the information from this study alone or in combination with data collected in other studies. All data except Protected Health Information may be shared. Data may be shared as Supplemental Information uploaded to a journal website and/or shared on a UW data sharing website. Data sharing would not require any further participation from participants. Participants may withdraw their data from future research by submitting a request in writing to our study team.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Sasha Sommerfeldt, M.S. principal investigator

University of Wisconsin, Madison

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Mindfulness training and Tracking time spent on mobile device in people with Not Seeking to Treat Any Conditions, run by University of Wisconsin, Madison at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in subjective stress-heart rate coherence (time frame: Baseline and post-test, separated by 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04125758, which also lists 28 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2022.