Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
NCT Number: NCT04866901
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.
Looking for future studies?
Notify Me18 year–24 year
All sexes
Interventional
Not applicable
Boston, Massachusetts, 02215, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
see arm description
see arm description
see arm description
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.
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).
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.
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.
Beth Israel Deaconess Medical Center
Other
Examining the Interactive Effects of Mindfulness and Slow-paced Breathing on Stress Physiology: A Pilot Study
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.
Published trials that share one or more normalized conditions with this study.
NCT05523414
Anxiety, Anxiety Disorders
San Diego, California, United States
View Trial DetailsNCT04907942
Anxiety Disorders, Behavior
New York, United States
View Trial DetailsNCT05019131
Adverse Outcomes, Behavior
Migori, Kenya
View Trial DetailsNCT06063174
Behavior, Behavioral Symptoms
Los Angeles, California, United States
View Trial Details