Prolific
Remote/Online, United Kingdom
NCT Number: NCT06064474
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.
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Notify Me18 year–39 year
All sexes
Interventional
Not applicable
Remote/Online, United Kingdom
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
(self-assessed):
Exclusion criteria
(self-assessed):
Intervention
Placebo
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: Post-intervention (immediately after the intervention)
Whether participants experienced unpleasant/unwanted short-term effects and/or lasting bad effects from the breathwork
Time frame: Post-intervention (immediately after the intervention)
Number of sessions participants self-report practicing out of 21 days assigned
Time frame: 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
Time frame: Follow-up (three weeks after the intervention)
Whether participants can correctly guess which condition they were allocated to
University of Sussex
Other
Effects of High Ventilation Breathwork With Retention (HVBR) on Mental Health and Wellbeing: A Randomised Placebo-controlled Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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