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Interactive Effects of Mindfulness and Slow-paced Breathing

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04866901
Enrollment
19
Registered
2021-04-30
Start date
2021-05-14
Completion date
2021-09-30
Last updated
2022-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep, Slow Breathing, Stress, Stress Physiology, Stress, Psychological

Keywords

stress, slow-paced breathing, breath training, mindfulness, yogic breathing, wellness, stress-management

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.

Interventions

BEHAVIORALSlow-Paced Breathing (SPB)

see arm description

BEHAVIORALMindfulness (M)

see arm description

BEHAVIORALYogic Breathing (SPB+M)

see arm description

Sponsors

Brigham and Women's Hospital
CollaboratorOTHER
Beth Israel Deaconess Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 24 Years
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?

Design outcomes

Primary

MeasureTime frameDescription
Breathing rate8-weeks (post-intervention), 15 minute practice session during the virtual laboratory visitParticipants 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 visitWe 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

MeasureTime frameDescription
Systolic blood pressure8-weeks (post-intervention), stress induction task (Stroop test) during the virtual laboratory visitWe 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 visitWe hypothesize that the combined SPB+M condition will show a pattern of higher HFnu.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026