Anxiety Clinical Trial
Official title:
Effects of High Ventilation Breathwork With Retention (HVBR) on Mental Health and Wellbeing: A Randomised Placebo-controlled Trial
Verified date | December 2023 |
Source | University of Sussex |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Prolific | Remote/Online |
Lead Sponsor | Collaborator |
---|---|
University of Sussex | Brighton & Sussex Medical School, Sylff Association, University of California, San Francisco |
United Kingdom,
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) |
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