StressNCT04866901
Interactive Effects of Mindfulness and Slow-paced Breathing
A study testing Slow-Paced Breathing (SPB), Mindfulness (M) and Yogic Breathing (SPB+M) in people with Stress and Stress, Psychological, run by Beth Israel Deaconess Medical Center at 1 site in United States.
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"). Read more about this study
- Who is it for?
- Ages 18 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress, Stress, Psychological, Stress Physiology
- What is being tested?
- Slow-Paced Breathing (SPB), Mindfulness (M) and Yogic Breathing (SPB+M)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 14 May 2021to 30 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 24 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18-24 years.
Who cannot join
- 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?"
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
Official title: Examining the Interactive Effects of Mindfulness and Slow-paced Breathing on Stress Physiology: A Pilot Study
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.
Read the 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
- Being tested
- Slow-Paced Breathing (SPB), Mindfulness (M), Yogic Breathing (SPB+M)
- Keywords
- stress, slow-paced breathing, breath training, mindfulness, yogic breathing, wellness, stress-management
- Medical subject headings
- Stress, Psychological, Hypoventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Slow-Paced Breathing (SPB)Behavioural
see arm description
Mindfulness (M)Behavioural
see arm description
Yogic Breathing (SPB+M)Behavioural
see arm description
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Behavioral: Yogic Breathing (SPB+M) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 8-weeks (post-intervention) completed electronically prior to virtual laboratory visit
Secondary outcomes (2)
Systolic blood pressure
We hypothesize that the combined SPB+M condition will show a pattern of lower systolic BP.
Measured: 8-weeks (post-intervention), stress induction task (Stroop test) during the virtual laboratory visit
Heart rate variability (normalized high-frequency power, HFnu)
We hypothesize that the combined SPB+M condition will show a pattern of higher HFnu.
Measured: 8-weeks (post-intervention), stress induction task (Stroop test) during the virtual laboratory visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2021
- Study start14 May 2021
- Primary completion30 Sep 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Brigham and Women's Hospital
- Responsible party
- Principal investigator, Michael R. Goldstein, Beth Israel Deaconess Medical Center
- Investigators
- Michael R Goldstein, PhD, Principal investigator, Beth Israel Deaconess Medical Center, Harvard Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04866901
- Sponsor's protocol ID
- 2020P000992
- Status last verified
- Mar 2022
- First submitted
- 27 Apr 2021
- Last updated
- 3 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Interactive Effects of Mindfulness and Slow-paced Breathing on Stress Physiology: A Pilot Study
- ClinicalTrials.gov ID
- NCT04866901
- Acronym / sponsor ID
- 2020P000992
- Conditions
- Stress, Stress, Psychological, Stress Physiology, Sleep, Slow Breathing
- Keywords
- stress, slow-paced breathing, breath training, mindfulness, yogic breathing, wellness, stress-management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Collaborators
- Brigham and Women's Hospital
- Study start
- 14 May 2021 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 30 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Slow-Paced Breathing (SPB) | Experimental | Behavioral: 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. |
| Mindfulness (M) | Experimental | Behavioral: 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. |
| Yogic Breathing (SPB+M) | Experimental | Behavioral: 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. |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Age 18-24 years.
Key exclusion criteria (4 listed)
- 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?"
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Slow-Paced Breathing (SPB)see arm description | Behavioural | Slow-Paced Breathing (SPB) |
| Mindfulness (M)see arm description | Behavioural | Mindfulness (M) |
| Yogic Breathing (SPB+M)see arm description | Behavioural | Yogic Breathing (SPB+M) |
Primary outcome
Breathing rate
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.
Five Facet Mindfulness Questionnaire (FFMQ)
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).
2 secondary outcomes
Systolic blood pressure
Time frame: 8-weeks (post-intervention), stress induction task (Stroop test) during the virtual laboratory visit
Heart rate variability (normalized high-frequency power, HFnu)
Time frame: 8-weeks (post-intervention), stress induction task (Stroop test) during the virtual laboratory visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael R Goldstein, PhD principal investigator
Beth Israel Deaconess Medical Center, Harvard Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Slow-Paced Breathing (SPB), Mindfulness (M) and Yogic Breathing (SPB+M) in people with Stress and Stress, Psychological, run by Beth Israel Deaconess Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Breathing rate (time frame: 8-weeks (post-intervention), 15 minute practice session during the virtual laboratory visit). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2022.