Effects of Coherent Breathing Breathwork on Health

Anxiety Clinical Trial

Official title:

Effects of Coherent Breathing Breathwork on Mental Health and Wellbeing: A Randomised Placebo-controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05676658
• Other study ID #: Sussex coherent breath study
• Status: Completed
• Phase: N/A
• Start date: February 22, 2023
• Est. completion date: April 26, 2023

Study information

• Verified date: May 2023
• Source: University of Sussex
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: April 26, 2023
• Est. primary completion date: April 26, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Depression
• Depressive Symptoms
• Dyssomnias
• Parasomnias
• Sleep Disturbance
• Stress
• Wellbeing

Intervention

Behavioral:
• Coherent breathing
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.
• Placebo coherent breathing
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.

Locations

Country	Name	City	State
United Kingdom	Prolific	Remote/Online

Sponsors (2)

Lead Sponsor	Collaborator
University of Sussex	Sylff Association

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Other	Impairment of practice	Optional open-ended question on whether anything impaired participants' ability to perform their randomly allocated breathwork	Post-intervention (immediately after the intervention)
Other	Hypothesis guessing	Optional open-ended question on whether participants can guess the hypothesis of the study	Follow-up (four 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 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
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 four 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 four weeks after the intervention)
Secondary	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)
Secondary	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)
Secondary	Self-reported adherence to protocol	Number of sessions participants self-report practicing out of 28 days assigned	Post-intervention (immediately after the intervention)
Secondary	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