Anxiety, Depressive Symptoms, Mental Wellbeing, Negative Affect, Positive Affect, Sleep-Related Impairment, Stress
Conditions
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.
Interventions
BEHAVIORALHigh ventilation breathwork with retention (HVBR)
Intervention
BEHAVIORALPlacebo HVBR
Placebo
Sponsors
Sylff Association
Brighton & Sussex Medical School
University of California, San Francisco
University of Sussex
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 39 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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) |
| 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 |
| 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 |
| 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) |
| 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 |
| Self-reported adherence to protocol | Post-intervention (immediately after the intervention) | Number of sessions participants self-report practicing out of 21 days assigned |
| 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) |
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Hypothesis guessing | Follow-up (three weeks after the intervention) | Whether participants can correctly guess which condition they were allocated to |
Countries
United Kingdom
Outcome results
None listed