Interactive Effects of Mindfulness and Slow-paced Breathing

NCT04866901 | Completed

• 1 other identifier: 2020P000992
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

stress; slow-paced breathing; breath training; mindfulness; yogic breathing; wellness; stress-management

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• Systolic blood pressure

  8-weeks (post-intervention), stress induction task (Stroop test) during the virtual laboratory visit

• Heart rate variability (normalized high-frequency power, HFnu)

  8-weeks (post-intervention), stress induction task (Stroop test) during the virtual laboratory visit

Study Arms (3)

Slow-Paced Breathing (SPB)

EXPERIMENTAL

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.

Behavioral: Slow-Paced Breathing (SPB)

Mindfulness (M)

EXPERIMENTAL

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.

Behavioral: Mindfulness (M)

Yogic Breathing (SPB+M)

EXPERIMENTAL

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.

Behavioral: Yogic Breathing (SPB+M)

Interventions

Slow-Paced Breathing (SPB) BEHAVIORAL

see arm description

Slow-Paced Breathing (SPB)

Mindfulness (M) BEHAVIORAL

see arm description

Mindfulness (M)

Yogic Breathing (SPB+M) BEHAVIORAL

see arm description

Yogic Breathing (SPB+M)

Eligibility Criteria

• Age: 18 Years - 24 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18-24 years.

You may not qualify if:

• 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?"

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead
• Brigham and Women's Hospital: collaborator

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Stress, Psychological; Hypoventilation

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Respiratory Insufficiency; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Michael R Goldstein, PhD

  Beth Israel Deaconess Medical Center, Harvard Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Fellow

Study Record Dates

• First Submitted: April 27, 2021
• First Posted: April 30, 2021
• Study Start: May 14, 2021
• Primary Completion: September 30, 2021
• Study Completion: September 30, 2021
• Last Updated: March 3, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)