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Completed

NCT Number: NCT05676658

Effects of Coherent Breathing Breathwork on Health

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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Key information

Conditions

Stress Anxiety Anxiety Disorders Behavior Behavioral Symptoms Depression Depressive Symptoms Mental Disorders Nervous System Diseases Parasomnias Sleep Disturbance Sleep Wake Disorders Wellbeing

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Prolific

Remote/Online, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Subjective stress

    Time frame: 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

    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

Secondary outcomes

  1. Subjective anxiety

    Time frame: Pre-post intervention and follow-up (immediately before the intervention, immediately after the intervention, and four weeks after the intervention)

    DASS-21 - anxiety subscale (score range: 0-21; higher scores denote worse outcome)

  2. Subjective depressive symptoms

    Time frame: Pre-post intervention and follow-up (immediately before the intervention, immediately after the intervention, and four weeks after the intervention)

    DASS-21 - depression subscale (score range: 0-21; higher scores denote worse outcome)

  3. Subjective wellbeing

    Time frame: Pre-post intervention and follow-up (immediately before the intervention, immediately after the intervention, and four weeks after the intervention)

    The World Health Organisation-5 Well-Being Index (WHO-5) (score range: 0-25; higher scores denote better outcome)

  4. Subjective sleep disturbance

    Time frame: Pre-post intervention and follow-up (immediately before the intervention, immediately after the intervention, and four weeks after the intervention)

    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

  5. Self-reported adherence to protocol

    Time frame: Post-intervention (immediately after the intervention)

    Number of sessions participants self-report practicing out of 28 days assigned

  6. Self-reported credibility and expectancy of protocol

    Time frame: 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%. Higher scores denote greater credibility and/or expectancy of specific breathwork technique

Other outcomes

  1. Overall experience

    Time frame: Post-intervention and follow-up (immediately after the intervention, and four weeks after the intervention)

    Optional open-ended questions on participants' perspectives and overall experience of the protocol/study-period

  2. Impairment of practice

    Time frame: Post-intervention (immediately after the intervention)

    Optional open-ended question on whether anything impaired participants' ability to perform their randomly allocated breathwork

  3. Hypothesis guessing

    Time frame: Follow-up (four weeks after the intervention)

    Optional open-ended question on whether participants can guess the hypothesis of the study

Sponsors and collaborators

Lead sponsor

University of Sussex

Other

Collaborators

  • Sylff Association

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jan 9, 2023
Registry last updated
May 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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