Interactive Effects of Mindfulness and Slow-paced Breathing

Sponsor

Beth Israel Deaconess Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT04866901

Collaborator

Brigham and Women's Hospital (Other)

Enrollment

Location

Arms

4.6

Actual Duration (Months)

4.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Stress Stress, Psychological Stress Physiology Sleep Slow Breathing	Behavioral: Slow-Paced Breathing (SPB) Behavioral: Mindfulness (M) Behavioral: Yogic Breathing (SPB+M)	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

19 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Basic Science

Official Title:

Examining the Interactive Effects of Mindfulness and Slow-paced Breathing on Stress Physiology: A Pilot Study

Actual Study Start Date :

May 14, 2021

Actual Primary Completion Date :

Sep 30, 2021

Actual Study Completion Date :

Sep 30, 2021

Arms and Interventions

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.	Behavioral: Slow-Paced Breathing (SPB) 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.	Behavioral: Mindfulness (M) 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.	Behavioral: Yogic Breathing (SPB+M) see arm description

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.

Behavioral: Slow-Paced Breathing (SPB)

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.

Behavioral: Mindfulness (M)

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.

Behavioral: Yogic Breathing (SPB+M)

see arm description

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Systolic blood pressure [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.
Heart rate variability (normalized high-frequency power, HFnu) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 24 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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?"