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CompletedNCT04866901

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
Phase
N/A
Study type
Interventional
Enrollment
19 (actual)
Sponsor
Beth Israel Deaconess Medical Center · Academic / Other
Sex
All
Age
18 Years – 24 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALSlow-Paced Breathing (SPB)see arm description
BEHAVIORALMindfulness (M)see arm description
BEHAVIORALYogic Breathing (SPB+M)see arm description

Timeline

Start date
2021-05-14
Primary completion
2021-09-30
Completion
2021-09-30
First posted
2021-04-30
Last updated
2022-03-03

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT04866901. Inclusion in this directory is not an endorsement.

Interactive Effects of Mindfulness and Slow-paced Breathing (NCT04866901) · Clinical Trials Directory