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Interactive Effects of Mindfulness and Slow-paced Breathing

Primary Purpose

Stress, Stress, Psychological, Stress Physiology

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Slow-Paced Breathing (SPB)
Mindfulness (M)
Yogic Breathing (SPB+M)
Sponsored by
Beth Israel Deaconess Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Stress focused on measuring stress, slow-paced breathing, breath training, mindfulness, yogic breathing, wellness, stress-management

Eligibility Criteria

18 Years - 24 Years (Adult)All SexesAccepts Healthy Volunteers

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?"

Sites / Locations

  • Beth Israel Deaconess Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Slow-Paced Breathing (SPB)

Mindfulness (M)

Yogic Breathing (SPB+M)

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Breathing rate
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.
Five Facet Mindfulness Questionnaire (FFMQ)
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).

Secondary Outcome Measures

Systolic blood pressure
We hypothesize that the combined SPB+M condition will show a pattern of lower systolic BP.
Heart rate variability (normalized high-frequency power, HFnu)
We hypothesize that the combined SPB+M condition will show a pattern of higher HFnu.

Full Information

First Posted
April 27, 2021
Last Updated
March 2, 2022
Sponsor
Beth Israel Deaconess Medical Center
Collaborators
Brigham and Women's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04866901
Brief Title
Interactive Effects of Mindfulness and Slow-paced Breathing
Official Title
Examining the Interactive Effects of Mindfulness and Slow-paced Breathing on Stress Physiology: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
May 14, 2021 (Actual)
Primary Completion Date
September 30, 2021 (Actual)
Study Completion Date
September 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beth Israel Deaconess Medical Center
Collaborators
Brigham and Women's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to better understand specific stress-management practices on mood, sleep, and physiology. Participants will be assigned to one of three interventions (they all active interventions - none are a "wait-list"). Each intervention asks participants to engage in a daily practice of 20 minutes per day for 8 weeks. Questionnaires and measures of heart rate and blood pressure will be collected at the start and end of the 8 weeks, including a virtual laboratory visit.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress, Stress, Psychological, Stress Physiology, Sleep, Slow Breathing
Keywords
stress, slow-paced breathing, breath training, mindfulness, yogic breathing, wellness, stress-management

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Slow-Paced Breathing (SPB)
Arm Type
Experimental
Arm Description
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.
Arm Title
Mindfulness (M)
Arm Type
Experimental
Arm Description
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.
Arm Title
Yogic Breathing (SPB+M)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Slow-Paced Breathing (SPB)
Intervention Description
see arm description
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness (M)
Intervention Description
see arm description
Intervention Type
Behavioral
Intervention Name(s)
Yogic Breathing (SPB+M)
Intervention Description
see arm description
Primary Outcome Measure Information:
Title
Breathing rate
Description
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.
Time Frame
8-weeks (post-intervention), 15 minute practice session during the virtual laboratory visit
Title
Five Facet Mindfulness Questionnaire (FFMQ)
Description
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).
Time Frame
8-weeks (post-intervention) completed electronically prior to virtual laboratory visit
Secondary Outcome Measure Information:
Title
Systolic blood pressure
Description
We hypothesize that the combined SPB+M condition will show a pattern of lower systolic BP.
Time Frame
8-weeks (post-intervention), stress induction task (Stroop test) during the virtual laboratory visit
Title
Heart rate variability (normalized high-frequency power, HFnu)
Description
We hypothesize that the combined SPB+M condition will show a pattern of higher HFnu.
Time Frame
8-weeks (post-intervention), stress induction task (Stroop test) during the virtual laboratory visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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?"
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael R Goldstein, PhD
Organizational Affiliation
Beth Israel Deaconess Medical Center, Harvard Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Interactive Effects of Mindfulness and Slow-paced Breathing

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