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

NCT06064474 | Completed

• 1 other identifier: Sussex fast breathwork study
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Subjective anxiety

  Pre-post intervention and follow-up (immediately before the intervention, immediately after the intervention, and three weeks after the intervention)

• Subjective depressive symptoms

  Pre-post intervention and follow-up (immediately before the intervention, immediately after the intervention, and three weeks after the intervention)

• Subjective mental wellbeing

  Pre-post intervention and follow-up (immediately before the intervention, immediately after the intervention, and three weeks after the intervention)

• Subjective sleep-related impairment

  Pre-post intervention and follow-up (immediately before the intervention, immediately after the intervention, and three weeks after the intervention)

• Subjective positive affect

  Pre-intervention (immediately before the intervention), post first breathwork session (immediately after starting breathwork), and post-intervention (immediately after the intervention)

Other Outcomes (2)

• Overall experience

  Post-intervention and follow-up (immediately after the intervention, and three weeks after the intervention)

• Hypothesis guessing

  Follow-up (three weeks after the intervention)

Study Arms (2)

High ventilation breathwork with retention (HVBR)

EXPERIMENTAL

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)

Placebo HVBR

PLACEBO COMPARATOR

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

Interventions

High ventilation breathwork with retention (HVBR) BEHAVIORAL

Intervention

High ventilation breathwork with retention (HVBR)

Placebo HVBR BEHAVIORAL

Placebo

Placebo HVBR

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Sussex: lead
• Sylff Association: collaborator
• Brighton & Sussex Medical School: collaborator
• University of California, San Francisco: collaborator

Study Sites (1)

Prolific

Remote/Online, United Kingdom

Location

MeSH Terms

Conditions

Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Guy W Fincham, MSc

  University of Sussex

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 26, 2023
• First Posted: October 3, 2023
• Study Start: October 13, 2023
• Primary Completion: December 11, 2023
• Study Completion: December 11, 2023
• Last Updated: December 20, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Indefinitely after the study has been completed.
• 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.

Locations

GB (1)