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

Study Overview
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Brief Summary
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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.

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

Conditions
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Stress, Anxiety, Depressive Symptoms, Mental Wellbeing, Positive Affect, Negative Affect, Sleep-Related Impairment

Intervention / Treatment
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* Behavioral: High ventilation breathwork with retention (HVBR)
* Behavioral: Placebo HVBR


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 39 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High ventilation breathwork with retention (HVBR)<br>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)<br>* Intervention<br>|
| Placebo Comparator: Placebo HVBR<br>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<br>* Placebo<br>|

What is the study measuring?
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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) |