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| Name | Class |
|---|---|
| Sylff Association | UNKNOWN |
| Brighton & Sussex Medical School | OTHER |
| University of California, San Francisco | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High ventilation breathwork with retention (HVBR) | Behavioral | Intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Subjective depressive symptoms |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Hypothesis guessing |
Inclusion Criteria (self-assessed):
Exclusion Criteria (self-assessed):
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| Name | Affiliation | Role |
|---|---|---|
| Guy W Fincham, MSc | University of Sussex | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prolific | Remote/Online | United Kingdom |
All participant data will be anonymous (only Prolific user IDs will be seen). No identifiable personal information will be collected. Participants will be able to check a box if they are happy for our research team at the University of Sussex to include the data again in future studies related to breathwork and meditation, as well as share with other research groups, if these have gained independent ethical approval, based on the strict confidentiality terms described in the participant info/consent form.
Indefinitely after the study has been completed.
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.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 9, 2023 | Oct 9, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 9, 2023 | Oct 9, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D003863 | Depression |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| Placebo HVBR | Behavioral | Placebo |
|
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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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 |
| 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) |
| Self-reported adherence to protocol | Number of sessions participants self-report practicing out of 21 days assigned | Post-intervention (immediately after the intervention) |
Whether participants can correctly guess which condition they were allocated to
| Follow-up (three weeks after the intervention) |