Effects of Coherent Breathing Breathwork on Health

Sponsor
University of Sussex (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05676658
Collaborator
Sylff Association (Other)
400
2
2.9

Study Details

Study Description

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, well-being and sleep disturbance 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, well-being, and sleep disturbance 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, well-being and sleep disturbance, if any. Open-ended responses on participants' overall experience of the protocol/study will also be collected.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Coherent breathing
  • Behavioral: Placebo coherent breathing
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
400 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Effects of Coherent Breathing Breathwork on Mental Health and Sleep: A Randomised Placebo-controlled Study
Anticipated Study Start Date :
Feb 1, 2023
Anticipated Primary Completion Date :
Apr 1, 2023
Anticipated Study Completion Date :
May 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Coherent breathing

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 Comparator: Placebo coherent breathing

Behavioral: 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.

Outcome Measures

Primary Outcome Measures

  1. Subjective stress [Pre-post intervention and follow-up (immediately before the intervention, immediately after the intervention, and four weeks after the intervention)]

    Depression Anxiety Stress Scale-21 (DASS-21) - stress subscale (score range: 0-21; higher scores denote worse outcome)

Secondary Outcome Measures

  1. Subjective anxiety [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 [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 well-being [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 [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)

  5. Self-reported adherence to protocol [Post-intervention (immediately after the intervention)]

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

Other Outcome Measures

  1. Overall experience [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University of Sussex
  • Sylff Association

Investigators

  • Principal Investigator: Guy W Fincham, MSc, University of Sussex

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Guy Fincham, Guy William Fincham, University of Sussex
ClinicalTrials.gov Identifier:
NCT05676658
Other Study ID Numbers:
  • Sussex coherent breath study
First Posted:
Jan 9, 2023
Last Update Posted:
Jan 9, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 9, 2023