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

Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06064474
• Other study ID #: Sussex fast breathwork study
• Status: Completed
• Phase: N/A
• Start date: October 13, 2023
• Est. completion date: December 11, 2023

Study information

• Verified date: December 2023
• Source: University of Sussex
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: December 11, 2023
• Est. primary completion date: December 11, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 39 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Depression
• Depressive Symptoms
• Mental Wellbeing
• Positive Affect
• Sleep-Related Impairment
• Stress

Intervention

Behavioral:
• High ventilation breathwork with retention (HVBR)
Intervention
• Placebo HVBR
Placebo

Locations

Country	Name	City	State
United Kingdom	Prolific	Remote/Online

Sponsors (4)

Lead Sponsor	Collaborator
University of Sussex	Brighton & Sussex Medical School, Sylff Association, University of California, San Francisco

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Other	Hypothesis guessing	Whether participants can correctly guess which condition they were allocated to	Follow-up (three weeks after the intervention)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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
Secondary	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)
Secondary	Self-reported adherence to protocol	Number of sessions participants self-report practicing out of 21 days assigned	Post-intervention (immediately after the intervention)