Interactive Effects of Mindfulness and Slow-paced Breathing

NCT ID: NCT04866901

Last Updated: 2022-03-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-14
• Study Completion Date: 2021-09-30

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Slow-Paced Breathing (SPB)

Intervention Type: BEHAVIORAL

see arm description

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.

Group Type: EXPERIMENTAL

Mindfulness (M)

Intervention Type: BEHAVIORAL

see arm description

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.

Group Type: EXPERIMENTAL

Yogic Breathing (SPB+M)

Intervention Type: BEHAVIORAL

see arm description

Interventions

Slow-Paced Breathing (SPB)

see arm description

Intervention Type: BEHAVIORAL

Mindfulness (M)

see arm description

Intervention Type: BEHAVIORAL

Yogic Breathing (SPB+M)

see arm description

Intervention Type: BEHAVIORAL

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?"

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 24 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Brigham and Women's Hospital

OTHER

Sponsor Role: collaborator

Beth Israel Deaconess Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Michael R. Goldstein

Research Fellow

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael R Goldstein, PhD

Role: PRINCIPAL_INVESTIGATOR

Beth Israel Deaconess Medical Center, Harvard Medical School

Locations

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

2020P000992

Identifier Type: -

Identifier Source: org_study_id