Interactive Effects of Mindfulness and Slow-paced Breathing

Stress Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04866901
• Other study ID #: 2020P000992
• Status: Completed
• Phase: N/A
• Start date: May 14, 2021
• Est. completion date: September 30, 2021

Study information

• Verified date: March 2022
• Source: Beth Israel Deaconess Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: September 30, 2021
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 24 Years

Eligibility

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?"

Related Conditions & MeSH terms

• Respiratory Aspiration
• Sleep
• Stress
• Stress Physiology
• Stress, Psychological

Intervention

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

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center	Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Breathing rate	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.	8-weeks (post-intervention), 15 minute practice session during the virtual laboratory visit
Primary	Five Facet Mindfulness Questionnaire (FFMQ)	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).	8-weeks (post-intervention) completed electronically prior to virtual laboratory visit
Secondary	Systolic blood pressure	We hypothesize that the combined SPB+M condition will show a pattern of lower systolic BP.	8-weeks (post-intervention), stress induction task (Stroop test) during the virtual laboratory visit
Secondary	Heart rate variability (normalized high-frequency power, HFnu)	We hypothesize that the combined SPB+M condition will show a pattern of higher HFnu.	8-weeks (post-intervention), stress induction task (Stroop test) during the virtual laboratory visit