Effects of Coherent Breathing Breathwork on Health

Effects of Coherent Breathing Breathwork on Mental Health and Wellbeing: A Randomised Placebo-controlled Study

The investigators are conducting a randomised-controlled trial comparing coherent breathing at ~5.5 breath cycles per minute-bcpm (with equal inhalation/exhalation durations of ~5.5secs each) to a well-designed placebo (paced breathing at 12bcpm with equal inhalation/exhalation durations of 2.5secs each). The metric of 12bcpm is in line with guidance from the British Journal of Nursing, Royal College of Physicians, and Johns Hopkins University which state that the average, healthy bcpm should range from: 12-20bcpm, 12-18bcpm, and 12-16bcpm, respectively, hence the investigators chose the minimum/lower bound for the active placebo control group. The main questions that our study attempts to address are: Does coherent breathing (and placebo coherent breathing) lead to improved mental health and wellbeing in a general population adult sample?

The study will be conducted entirely online through the research platform Prolific, so participant data will be anonymous. The investigators will collect self-reports of mental health and wellbeing before and after the four-week breathwork period, along with a follow-up one-month later. Pre-post intervention and follow-up questionnaires will be completed online via the survey platform Qualtrics which will be linked to Prolific. Participants will also be asked how many times they practiced out of the assigned 28 days, to gauge self-reported adherence to the protocol. The investigators can then observe whether self-reported adherence correlates with changes in mental health and wellbeing, if any. Data on the self-reported credibility/expectancy of the breathwork randomly allocated to participants will also be collected, along with open-ended responses on participants' overall experience of the protocol/study.

Study Overview

• Status: Completed
• Conditions: Wellbeing; Stress; Anxiety; Sleep Disturbance; Depressive Symptoms
• Intervention / Treatment: Behavioral: Coherent breathing; Behavioral: Placebo coherent breathing

• Study Type: Interventional
• Enrollment (Actual): 400
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Remote/Online, United Kingdom
    • Prolific

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria (self-assessed):

• 18+ years of age (18 is the automatic minimum age on Prolific)
• Able to breathe through nose
• Have access to headphones
• The following pre-screeners on Prolific will also be set so only those eligible on Prolific will see the study: Located/living in UK, Fluent in English, approval rate of 98% and at least 20 previous submissions (as recommended by Prolific to increase retention and reduce dropout rates in longitudinal and multi-part studies)

Exclusion Criteria (self-assessed):

• Any problems which affect ones ability to pace their breathing (i.e., active/chronic respiratory infection including blocked nose/cough/cold/fever, etc.), breathlessness, cardiovascular problems, respiratory conditions or diseases (i.e., uncontrolled symptomatic asthma, COPD, lung cancer, etc.), abnormally slow breathing (bradypnea), or abnormally fast breathing (tachypnoea)
• Any other physical/mental health conditions or current life events which impair or affect ones ability to engage in activities involving breath control

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Coherent breathing	Behavioral: Coherent breathing; Guided audio of coherent breathing pre-recorded by trained breathwork facilitator: ~5.5bcpm (with equal inhalation/exhalation durations of ~5.5secs each) for ~10mins/day over four weeks / 28 days. Delivered remotely through audio link.
Placebo Comparator: Placebo coherent breathing	Behavioral: Placebo coherent breathing; Same audio of coherent breathing but paced at: ~12bcpm (with equal inhalation/exhalation durations of 2.5secs each) for ~10mins/day over four weeks / 28 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective stress	Depression Anxiety Stress Scale-21 (DASS-21) - stress subscale (score range: 0-21; higher scores denote worse outcome). Score on DASS-21 is then multiplied by two to convert it to the longer form DASS-42 final score	Pre-post intervention and follow-up (immediately before the intervention, immediately after the intervention, and four weeks after the intervention). Primary timepoint is post-intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective anxiety	DASS-21 - anxiety subscale (score range: 0-21; higher scores denote worse outcome)	Pre-post intervention and follow-up (immediately before the intervention, immediately after the intervention, and four weeks after the intervention)
Subjective depressive symptoms	DASS-21 - depression subscale (score range: 0-21; higher scores denote worse outcome)	Pre-post intervention and follow-up (immediately before the intervention, immediately after the intervention, and four weeks after the intervention)
Self-reported adherence to protocol	Number of sessions participants self-report practicing out of 28 days assigned	Post-intervention (immediately after the intervention)
Subjective wellbeing	The World Health Organisation-5 Well-Being Index (WHO-5) (score range: 0-25; higher scores denote better outcome)	Pre-post intervention and follow-up (immediately before the intervention, immediately after the intervention, and four weeks after the intervention)
Subjective sleep disturbance	PROMIS Item Bank v1.0 - Sleep Disturbance - Short Form 8a (score range: 5-40; higher scores denote worse outcome). Data scored using a T-score transformation according to PROMIS Sleep scoring manual on: www.healthmeasures.net	Pre-post intervention and follow-up (immediately before the intervention, immediately after the intervention, and four weeks after the intervention)
Self-reported credibility and expectancy of protocol	Credibility/Expectancy Questionnaire (CEQ-6). Two Sets (Credibility of course/therapy [breathwork] and expectancy of course/therapy [breathwork]). Four items scored 1-9 and two items scored 0-100%. Higher scores denote greater credibility and/or expectancy of specific breathwork technique	Immediately after starting breathwork intervention

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall experience	Optional open-ended questions on participants' perspectives and overall experience of the protocol/study-period	Post-intervention and follow-up (immediately after the intervention, and four weeks after the intervention)
Impairment of practice	Optional open-ended question on whether anything impaired participants' ability to perform their randomly allocated breathwork	Post-intervention (immediately after the intervention)
Hypothesis guessing	Optional open-ended question on whether participants can guess the hypothesis of the study	Follow-up (four weeks after the intervention)

Collaborators and Investigators

• Sponsor: University of Sussex
• Collaborators: Sylff Association
• Investigators: Principal Investigator: Guy W Fincham, MSc, University of Sussex

Study record dates

Study Major Dates

• Study Start (Actual): February 22, 2023
• Primary Completion (Actual): April 26, 2023
• Study Completion (Actual): April 26, 2023

Study Registration Dates

• First Submitted: December 14, 2022
• First Submitted That Met QC Criteria: January 4, 2023
• First Posted (Actual): January 9, 2023

Study Record Updates

• Last Update Posted (Actual): May 15, 2023
• Last Update Submitted That Met QC Criteria: May 11, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Nervous System Diseases; Sleep Wake Disorders; Depression; Dyssomnias; Parasomnias
• Other Study ID Numbers: Sussex coherent breath study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All participant data will be anonymous (only Prolific user IDs will be seen). No identifiable personal information will be collected. Participants will be able to check a box if they are happy for our research team at the University of Sussex to include the data again in future studies related to breathwork and meditation if these have gained independent ethically approval, based on the strict confidentiality terms described in the participant info/consent form.
• IPD Sharing Time Frame: Indefinitely after the study has been completed.
• IPD Sharing Access Criteria: Our research team at the University of Sussex will have access. The datasets used and/or analysed during the current study will be available from the principal investigator on reasonable request to other researchers working on meditation and breathwork.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No