Effects of High Ventilation Breathwork With Retention (HVBR) on Health

Effects of High Ventilation Breathwork With Retention (HVBR) on Mental Health and Wellbeing: A Randomised Placebo-controlled Trial

The investigators are conducting a randomised-controlled trial comparing high ventilation breathwork with retention (HVBR) to a breathwork placebo (paced breathing at 15breaths/min with brief retentions). The metric of 15b/min aligns with guidance from the British Journal of Nursing, Royal College of Physicians and Johns Hopkins Medicine which state that the average, healthy rate should range from: 12-20, 12-18 and 12-16b/min, respectively. The main questions the study attempts to address are: Does HVBR lead to improved state and trait 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 three-week breathwork period, in addition to a follow-up three weeks later. Pre-post intervention and follow-up questionnaires will be completed online via the survey platform Qualtrics which will be linked to Prolific. Data on self-reported adherence to, and credibility/expectancy of, the breathwork will also be collected, along with participants' experiences to gauge the safety and tolerability of the breathwork protocol.

Study Overview

• Status: Completed
• Conditions: Stress; Anxiety; Depressive Symptoms; Positive Affect; Sleep-Related Impairment; Mental Wellbeing; Negative Affect
• Intervention / Treatment: Behavioral: High ventilation breathwork with retention (HVBR); Behavioral: Placebo HVBR

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Guy W Fincham, MSc; Phone Number: +44 (0)1273 876638; Email: g.fincham@sussex.ac.uk
• Study Contact Backup: Name: Kate Cavanagh, PhD; Phone Number: +44 (0)1273 876638; Email: kate.cavanagh@sussex.ac.uk

Study Locations

• United Kingdom
  • Remote/Online, United Kingdom
    • Prolific
    • Contact: Guy W Fincham

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria (self-assessed):

• Fluent in English and living in the UK
• Have access to headphones
• Comfortable with faster breathing and holding breath
• Willing to only practice breathwork in safe environment, lying down in soft area (i.e., bed, sofa, carpet/mat), and always away from water & hard ground
• Willing to only practice the breathwork away from large meals (i.e., before or 1hour after) and bedtime (i.e., at least 1 hour before if practicing in evening)

Exclusion Criteria (self-assessed):

• Hypotension or hypertension (low or high blood pressure)
• History of respiratory or cardiovascular/heart problems or disease
• History of fainting or syncope
• Epilepsy or seizures
• History of panic disorder or panic attacks
• Cerebral aneurysm
• Have had problems with prior breathwork sessions (i.e., fainting)
• Pregnancy, think one might be pregnant, trying to get pregnant, or are breastfeeding
• Any problems which affect one's ability to pace their breathing (i.e., active/chronic respiratory infection including blocked nose/cough/cold/fever, etc.), breathlessness, abnormally slow breathing (bradypnea), or abnormally fast breathing (tachypnoea)
• Any other physical/mental health conditions or current life events which impair or affect one's ability to engage in activities involving breath control
• Are taking any regular medication other than the contraceptive pill, including medications to reduce blood pressure (i.e., Ramipril or other ACE-inhibitors), beta blockers (i.e., Propranolol), antidepressants, anxiolytics or any other psychotropic medications

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: High ventilation breathwork with retention (HVBR); Guided audio of HVBR pre-recorded by a trained breathwork facilitator for ~20min/day over 21 days (three weeks). Delivered remotely through audio link, comprising evocative music and four rounds of hyperventilation with four separate retentions (breath holds), progressively increasing in length (from ~45seconds up to ~90 seconds).	Behavioral: High ventilation breathwork with retention (HVBR); Intervention
Placebo Comparator: Placebo HVBR; Guided audio of placebo HVBR pre-recorded by a trained breathwork facilitator for ~20min/day over 21 days (three weeks). Delivered remotely through audio link, comprising music and four rounds of paced breathing at 15b/min (equal inhale:exhale) with four separate brief retentions, progressively increasing in length (from ~10secs to ~25secs).	Behavioral: Placebo HVBR; Placebo

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 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 three 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 three 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 three weeks after the intervention)
Subjective mental wellbeing	Short Warwick-Edinburgh Mental Wellbeing Scale (SWEMWBS) (score range: 7 to 35; higher scores denote better outcome). Total raw scores are then transformed into metric scores using the SWEMWBS conversion table on: www.warwick.ac.uk	Pre-post intervention and follow-up (immediately before the intervention, immediately after the intervention, and three weeks after the intervention)
Subjective sleep-related impairment	PROMIS Item Bank v. 1.0 - Sleep-Related Impairment - Short Form 4a (score range: 5-20; 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 three weeks after the intervention)
Subjective positive affect	Positive and Negative Affect Schedule (PANAS) positive affect subscale (score range: 10-50; higher scores denote better outcome)	Pre-intervention (immediately before the intervention), post first breathwork session (immediately after starting breathwork), and post-intervention (immediately after the intervention)
Subjective negative affect	PANAS negative affect subscale (score range: 10-50; higher scores denote worse outcome)	Pre-intervention (immediately before the intervention), post first breathwork session (immediately after starting breathwork), and post-intervention (immediately after the intervention)
Subjective 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%. Scores for expectancy set then standardised via converting them to z-scores. Higher scores denote greater credibility and/or expectancy of specific breathwork technique	Immediately after starting breathwork intervention
Negative side effects due to protocol	Whether participants experienced unpleasant/unwanted short-term effects and/or lasting bad effects from the breathwork	Post-intervention (immediately after the intervention)
Self-reported adherence to protocol	Number of sessions participants self-report practicing out of 21 days assigned	Post-intervention (immediately after the intervention)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall experience	Participants' perspectives and overall experience of the protocol/study-period	Post-intervention and follow-up (immediately after the intervention, and three weeks after the intervention)
Hypothesis guessing	Whether participants can correctly guess which condition they were allocated to	Follow-up (three weeks after the intervention)

Collaborators and Investigators

• Sponsor: University of Sussex
• Collaborators: University of California, San Francisco; Brighton & Sussex Medical School; Sylff Association
• Investigators: Principal Investigator: Guy W Fincham, MSc, University of Sussex

Study record dates

Study Major Dates

• Study Start (Actual): October 13, 2023
• Primary Completion (Actual): December 11, 2023
• Study Completion (Actual): December 11, 2023

Study Registration Dates

• First Submitted: September 26, 2023
• First Submitted That Met QC Criteria: September 26, 2023
• First Posted (Actual): October 3, 2023

Study Record Updates

• Last Update Posted (Actual): December 20, 2023
• Last Update Submitted That Met QC Criteria: December 19, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: Sussex fast breathwork 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, as well as share with other research groups, if these have gained independent ethical 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 breathwork and meditation.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

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