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| Name | Class |
|---|---|
| Sylff Association | UNKNOWN |
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The investigators are conducting a randomised-controlled trial comparing coherent breathing at ~5.5 breath cycles per minute-bcpm (with equal inhalation/exhalation durations of ~5.5secs each) to a well-designed placebo (paced breathing at 12bcpm with equal inhalation/exhalation durations of 2.5secs each). The metric of 12bcpm is in line with guidance from the British Journal of Nursing, Royal College of Physicians, and Johns Hopkins University which state that the average, healthy bcpm should range from: 12-20bcpm, 12-18bcpm, and 12-16bcpm, respectively, hence the investigators chose the minimum/lower bound for the active placebo control group. The main questions that our study attempts to address are: Does coherent breathing (and placebo coherent breathing) lead to improved 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 four-week breathwork period, along with a follow-up one-month later. Pre-post intervention and follow-up questionnaires will be completed online via the survey platform Qualtrics which will be linked to Prolific. Participants will also be asked how many times they practiced out of the assigned 28 days, to gauge self-reported adherence to the protocol. The investigators can then observe whether self-reported adherence correlates with changes in mental health and wellbeing, if any. Data on the self-reported credibility/expectancy of the breathwork randomly allocated to participants will also be collected, along with open-ended responses on participants' overall experience of the protocol/study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Coherent breathing | Experimental |
| |
| Placebo coherent breathing | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Coherent breathing | Behavioral | Guided audio of coherent breathing pre-recorded by trained breathwork facilitator: ~5.5bcpm (with equal inhalation/exhalation durations of ~5.5secs each) for ~10mins/day over four weeks / 28 days. Delivered remotely through audio link. |
| 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 is 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 four 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 four weeks after the intervention) |
| Subjective depressive symptoms |
| Measure | Description | Time Frame |
|---|---|---|
| Overall experience | Optional open-ended questions on participants' perspectives and overall experience of the protocol/study-period | Post-intervention and follow-up (immediately after the intervention, and four weeks after the intervention) |
| Impairment of practice |
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 if these have gained independent ethically approval, based on the strict confidentiality terms described in the participant info/consent form.
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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 meditation and breathwork.
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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 | Mar 15, 2023 | Mar 15, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 15, 2023 | Mar 15, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D003863 | Depression |
| D020447 | Parasomnias |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D012893 | Sleep Wake Disorders |
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| Placebo coherent breathing | Behavioral | Same audio of coherent breathing but paced at: ~12bcpm (with equal inhalation/exhalation durations of 2.5secs each) for ~10mins/day over four weeks / 28 days. |
|
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 four weeks after the intervention) |
| Subjective wellbeing | The World Health Organisation-5 Well-Being Index (WHO-5) (score range: 0-25; higher scores denote better outcome) | Pre-post intervention and follow-up (immediately before the intervention, immediately after the intervention, and four weeks after the intervention) |
| Subjective sleep disturbance | PROMIS Item Bank v1.0 - Sleep Disturbance - Short Form 8a (score range: 5-40; 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 four weeks after the intervention) |
| Self-reported adherence to protocol | Number of sessions participants self-report practicing out of 28 days assigned | Post-intervention (immediately after the intervention) |
| Self-reported 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%. Higher scores denote greater credibility and/or expectancy of specific breathwork technique | Immediately after starting breathwork intervention |
Optional open-ended question on whether anything impaired participants' ability to perform their randomly allocated breathwork |
| Post-intervention (immediately after the intervention) |
| Hypothesis guessing | Optional open-ended question on whether participants can guess the hypothesis of the study | Follow-up (four weeks after the intervention) |
| D009422 |
| Nervous System Diseases |