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Completed

NCT Number: NCT04866901

Interactive Effects of Mindfulness and Slow-paced Breathing

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.

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Key information

Age range

18 year–24 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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?"

Treatment and study plan

Slow-Paced Breathing (SPB)

Behavioral

see arm description

Mindfulness (M)

Behavioral

see arm description

Yogic Breathing (SPB+M)

Behavioral

see arm description

Primary outcomes

  1. 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.

  2. 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).

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Beth Israel Deaconess Medical Center

Other

Collaborators

  • Brigham and Women's Hospital

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Apr 30, 2021
Registry last updated
Mar 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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