Clinical trial NCT04866901: Interactive Effects of Mindfulness and Slow-paced Breathing
Official title: Examining the Interactive Effects of Mindfulness and Slow-paced Breathing on Stress Physiology: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress
Stress, Psychological
Stress Physiology
Sleep
Slow Breathing
Keywords: stress
slow-paced breathing
breath training
mindfulness
yogic breathing
wellness
stress-management
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
Collaborators: name: Brigham and Women's Hospital
First posted: 2021-04-30
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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?"

Primary outcomes:
measure: Breathing rate
timeFrame: 8-weeks (post-intervention), 15 minute practice session during the virtual laboratory visit
measure: Five Facet Mindfulness Questionnaire (FFMQ)
timeFrame: 8-weeks (post-intervention) completed electronically prior to virtual laboratory visit
Secondary outcomes:
measure: Systolic blood pressure
timeFrame: 8-weeks (post-intervention), stress induction task (Stroop test) during the virtual laboratory visit
measure: Heart rate variability (normalized high-frequency power, HFnu)
timeFrame: 8-weeks (post-intervention), stress induction task (Stroop test) during the virtual laboratory visit
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center, Harvard Medical School
name: Michael R Goldstein, PhD
role: PRINCIPAL_INVESTIGATOR
References: