Clinical trial NCT05676658: Effects of Coherent Breathing Breathwork on Health
Official title: Effects of Coherent Breathing Breathwork on Mental Health and Wellbeing: A Randomised Placebo-controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress
Anxiety
Depressive Symptoms
Wellbeing
Sleep Disturbance
Lead sponsor: University of Sussex
Sponsor class: OTHER
Collaborators: name: Sylff Association
First posted: 2023-01-09
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria (self-assessed):

* 18+ years of age (18 is the automatic minimum age on Prolific)
* Able to breathe through nose
* Have access to headphones
* The following pre-screeners on Prolific will also be set so only those eligible on Prolific will see the study: Located/living in UK, Fluent in English, approval rate of 98% and at least 20 previous submissions (as recommended by Prolific to increase retention and reduce dropout rates in longitudinal and multi-part studies)

Exclusion Criteria (self-assessed):

* Any problems which affect ones ability to pace their breathing (i.e., active/chronic respiratory infection including blocked nose/cough/cold/fever, etc.), breathlessness, cardiovascular problems, respiratory conditions or diseases (i.e., uncontrolled symptomatic asthma, COPD, lung cancer, etc.), abnormally slow breathing (bradypnea), or abnormally fast breathing (tachypnoea)
* Any other physical/mental health conditions or current life events which impair or affect ones ability to engage in activities involving breath control

Primary outcomes:
measure: Subjective stress
timeFrame: 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
Secondary outcomes:
measure: Subjective anxiety
timeFrame: Pre-post intervention and follow-up (immediately before the intervention, immediately after the intervention, and four weeks after the intervention)
measure: Subjective depressive symptoms
timeFrame: Pre-post intervention and follow-up (immediately before the intervention, immediately after the intervention, and four weeks after the intervention)
measure: Subjective wellbeing
timeFrame: Pre-post intervention and follow-up (immediately before the intervention, immediately after the intervention, and four weeks after the intervention)
measure: Subjective sleep disturbance
timeFrame: Pre-post intervention and follow-up (immediately before the intervention, immediately after the intervention, and four weeks after the intervention)
measure: Self-reported adherence to protocol
timeFrame: Post-intervention (immediately after the intervention)
measure: Self-reported credibility and expectancy of protocol
timeFrame: Immediately after starting breathwork intervention
Other outcomes:
measure: Overall experience
timeFrame: Post-intervention and follow-up (immediately after the intervention, and four weeks after the intervention)
measure: Impairment of practice
timeFrame: Post-intervention (immediately after the intervention)
measure: Hypothesis guessing
timeFrame: Follow-up (four weeks after the intervention)
Locations:
city: Remote/Online
country: United Kingdom
facility: Prolific
Study officials:
affiliation: University of Sussex
name: Guy W Fincham, MSc
role: PRINCIPAL_INVESTIGATOR
References: