- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04866901
Interactive Effects of Mindfulness and Slow-paced Breathing
Examining the Interactive Effects of Mindfulness and Slow-paced Breathing on Stress Physiology: A Pilot Study
Study Overview
Status
Intervention / Treatment
Detailed Description
Slow-paced breathing (SPB), mindfulness (M), and their combination (SPB+M) in the form of yoga, yogic breathing, Tai Chi, Qigong, and other practices are considered distinct forms of intervention, yet are often considered inextricably linked and overlapping in their effects on the autonomic nervous system. Although the scientific community continues to build understanding of autonomic mechanisms that might be unique to SPB, M, and their interaction (SPB+M), no studies we are aware of have attempted to directly compare these three forms of intervention in a controlled fashion that enables a 'dismantling' framework of interpretation.
The goal of this pilot project is to compare the separate and combined effects of SPB and M on autonomic function. We will test the feasibility of a three-arm intervention trial (N=5 per group), involving 20-min daily practice for 8 weeks, with multimodal ambulatory autonomic measurement before and after intervention. We will first focus on a healthy young adult population to then inform translation to hypertension, insomnia, and other clinical groups.
Aim 1: Distinguish SPB, M, and SPB+M training in terms of breathing rate and subjective mindfulness.
Aim 2: Obtain pilot data comparing the three interventions in terms of autonomic regulation using both conventional metrics and non-linear dynamics.
Aim 3: Develop methods to examine relationships across domains of autonomic regulation, stress, and sleep for the three interventions.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02215
- Beth Israel Deaconess Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age 18-24 years.
Exclusion Criteria:
- Active infection/disease
- Current untreated mental or physical health condition deemed likely to interfere with ability to complete study procedures (determined by study staff consensus)
- Current use of medications with known effects on stress physiology (antidepressants [SSRI, SNSI, NDRI, atypical, TCA, MAOI], anitpsychotics, benzodiazepines, non-benzodiazepine receptor agonists, melatonin and melatonin receptor agonists, orexin/hypocretin receptor antagonists, barbiturates, mood stabilizers, anticonvulsants, anticholinergics, first generation antihistamines, and stimulants including NRI, antihypertensives, opioids, or systemic corticosteroids)
- Moderate/substantial prior meditation, yoga, or other mind-body practice self-reported as a self-rating of 5 or higher on a scale of 0-10 asking "How experienced are you with meditation, yoga, or other mind-body interventions?"
Study Plan
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Slow-Paced Breathing (SPB)
Participants will first be provided with a brief overview of the science of breathing and benefits for autonomic regulation.
Then, participants will receive specific practice instruction and guided breathing at a rhythm of 6 breaths/min (4-6 count) via auditory tones.
Each participant will be encouraged to breathe as comfortably and effortlessly as possible, while keeping the lungs moving in accordance with the audio guidance.
The accompanying training and daily instruction reminder will emphasize the importance of following the specific rhythm of breathing, without regard to thoughts or inner experience.
A soft but firm tone of voice will be employed to minimize likelihood of relaxing effects, while maintaining similarity to the tone of voice used in the other conditions.
|
see arm description
|
EXPERIMENTAL: Mindfulness (M)
Procedures are based on Berghoff et al., providing a brief history of mindfulness practices, definitions, instructions for practice, common challenges, and recommendations.
An audio recording will then guide the mindfulness practice.
Specific to this study, in order to further distinguish the three conditions, the guided audio recording will emphasize the importance of attending to the quality of experience while not changing or attending to breathing patterns.
|
see arm description
|
EXPERIMENTAL: Yogic Breathing (SPB+M)
Information from the other two conditions will be synthesized with the aim of eliciting attention to the same breathing instruction used for SPB, while also observing the quality of experience during the practice, as conducted for M.
|
see arm description
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Breathing rate
Time Frame: 8-weeks (post-intervention), 15 minute practice session during the virtual laboratory visit
|
Participants will wear a Polar H10 chest strap heart rate monitor during training and daily practice, and breathing rate will be derived from the HR interbeat interval series.
We expect participants randomized to SPB and SPB+M to show slower breathing rates compared to M during a recorded practice session at 8-weeks.
|
8-weeks (post-intervention), 15 minute practice session during the virtual laboratory visit
|
Five Facet Mindfulness Questionnaire (FFMQ)
Time Frame: 8-weeks (post-intervention) completed electronically prior to virtual laboratory visit
|
We expect M and SPB+M to more highly report qualities of experience consistent with mindfulness.
Primary outcome will focus on total score, summing across the five facets (total score range: 39-195; higher scores reflect higher mindfulness ratings).
|
8-weeks (post-intervention) completed electronically prior to virtual laboratory visit
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Systolic blood pressure
Time Frame: 8-weeks (post-intervention), stress induction task (Stroop test) during the virtual laboratory visit
|
We hypothesize that the combined SPB+M condition will show a pattern of lower systolic BP.
|
8-weeks (post-intervention), stress induction task (Stroop test) during the virtual laboratory visit
|
Heart rate variability (normalized high-frequency power, HFnu)
Time Frame: 8-weeks (post-intervention), stress induction task (Stroop test) during the virtual laboratory visit
|
We hypothesize that the combined SPB+M condition will show a pattern of higher HFnu.
|
8-weeks (post-intervention), stress induction task (Stroop test) during the virtual laboratory visit
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Michael R Goldstein, PhD, Beth Israel Deaconess Medical Center, Harvard Medical School
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020P000992
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Stress
-
Massachusetts General HospitalCompletedStress | Emotional Stress | Psychological Stress | Social Stress | Life StressUnited States
-
University of PadovaRecruitingStress | Stress Disorder | Work Related StressItaly
-
University of California, Los AngelesUniversity of California, San Francisco; Stanford University; California Initiative...Enrolling by invitationStress | Stress, Psychological | Stress, Emotional | Stress, Physiological | Stress ReactionUnited States
-
Duquesne UniversityUniversity of California, San Diego; West Penn Allegheny Health System; El Centro... and other collaboratorsTerminated
-
University of Sao PauloCompleted
-
Dana-Farber Cancer InstituteEnrolling by invitationStress | Post Traumatic Stress Disorder | Work Related StressUnited States
-
Syracuse VA Medical CenterUS Department of Veterans AffairsCompletedEmotional Stress | Psychological Stress | Life StressUnited States
-
Royal Cornwall Hospitals TrustEnrolling by invitationStress | Stress, Psychological | Stress, JobUnited Kingdom
-
Taichung Veterans General HospitalUnknown
-
Northumbria UniversityVolac International LtdRecruitingStress | Mood | Physiological StressUnited Kingdom
Clinical Trials on Slow-Paced Breathing (SPB)
-
Old Dominion UniversityCompletedAnxiety | Visceral Pain | Gastrointestinal System--AbnormalitiesUnited States
-
University of FloridaCompletedNonobstructive Coronary Artery DiseaseUnited States
-
Philips RespironicsCompletedSleep Apnea, ObstructiveUnited States
-
University of PennsylvaniaCompletedPulmonary Arterial HypertensionUnited States
-
The Netherlands Cancer InstituteRecruiting
-
The Hong Kong Polytechnic UniversityUniversity of California, Berkeley; University of WaterlooCompletedVision, Balance and Falls in Older AdultsChina
-
Oregon Health and Science UniversityNational Center for Complementary and Integrative Health (NCCIH); Oregon Clinical...CompletedPost-Traumatic Stress DisordersUnited States
-
University of Southern CaliforniaUniversity of California, IrvineCompletedAlzheimer Disease | Aging | Age-related Cognitive DeclineUnited States
-
University of MiamiNational Heart, Lung, and Blood Institute (NHLBI)Completed