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

Sponsor
University of Sussex (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06064474
Collaborator
Sylff Association (Other), Brighton & Sussex Medical School (Other), University of California, San Francisco (Other)
200
1
2
2
99.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: High ventilation breathwork with retention (HVBR)
  • Behavioral: Placebo HVBR
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Effects of High Ventilation Breathwork With Retention (HVBR) on Mental Health and Wellbeing: A Randomised Placebo-controlled Trial
Anticipated Study Start Date :
Oct 17, 2023
Anticipated Primary Completion Date :
Dec 17, 2023
Anticipated Study Completion Date :
Dec 17, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Subjective stress [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]

    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

Secondary Outcome Measures

  1. Subjective anxiety [Pre-post intervention and follow-up (immediately before the intervention, immediately after the intervention, and three weeks after the intervention)]

    DASS-21 - anxiety subscale (score range: 0-21; higher scores denote worse outcome)

  2. Subjective depressive symptoms [Pre-post intervention and follow-up (immediately before the intervention, immediately after the intervention, and three weeks after the intervention)]

    DASS-21 - depression subscale (score range: 0-21; higher scores denote worse outcome)

  3. Subjective mental wellbeing [Pre-post intervention and follow-up (immediately before the intervention, immediately after the intervention, and three weeks after the intervention)]

    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

  4. Subjective sleep-related impairment [Pre-post intervention and follow-up (immediately before the intervention, immediately after the intervention, and three weeks after the intervention)]

    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

  5. Subjective positive affect [Pre-intervention (immediately before the intervention), post first breathwork session (immediately after starting breathwork), and post-intervention (immediately after the intervention)]

    Positive and Negative Affect Schedule (PANAS) positive affect subscale (score range: 10-50; higher scores denote better outcome)

  6. Subjective negative affect [Pre-intervention (immediately before the intervention), post first breathwork session (immediately after starting breathwork), and post-intervention (immediately after the intervention)]

    PANAS negative affect subscale (score range: 10-50; higher scores denote worse outcome)

  7. Subjective credibility and expectancy of protocol [Immediately after starting breathwork intervention]

    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

  8. Negative side effects due to protocol [Post-intervention (immediately after the intervention)]

    Whether participants experienced unpleasant/unwanted short-term effects and/or lasting bad effects from the breathwork

  9. Self-reported adherence to protocol [Post-intervention (immediately after the intervention)]

    Number of sessions participants self-report practicing out of 21 days assigned

Other Outcome Measures

  1. Overall experience [Post-intervention and follow-up (immediately after the intervention, and three weeks after the intervention)]

    Participants' perspectives and overall experience of the protocol/study-period

  2. Hypothesis guessing [Follow-up (three weeks after the intervention)]

    Whether participants can guess the hypothesis of the study

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 39 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Prolific Remote/Online United Kingdom

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Guy W Fincham, MSc, University of Sussex

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Guy Fincham, Principal Investigator, University of Sussex
ClinicalTrials.gov Identifier:
NCT06064474
Other Study ID Numbers:
  • Sussex fast breathwork study
First Posted:
Oct 3, 2023
Last Update Posted:
Oct 6, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 6, 2023