Effects of Coherent Breathing Breathwork on Health

NCT05676658 | Completed

• 1 other identifier: Sussex coherent breath study
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress; Anxiety; Depressive Symptoms; Wellbeing; Sleep Disturbance

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Subjective anxiety

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

• Subjective depressive symptoms

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

• Subjective wellbeing

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

• Subjective sleep disturbance

  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

  Post-intervention (immediately after the intervention)

Other Outcomes (3)

• Overall experience

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

• Impairment of practice

  Post-intervention (immediately after the intervention)

• Hypothesis guessing

  Follow-up (four weeks after the intervention)

Study Arms (2)

Coherent breathing

EXPERIMENTAL

Behavioral: Coherent breathing

Placebo coherent breathing

PLACEBO COMPARATOR

Behavioral: Placebo coherent breathing

Interventions

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.

Coherent breathing

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.

Placebo coherent breathing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• + 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Sussex: lead
• Sylff Association: collaborator

Study Sites (1)

Prolific

Remote/Online, United Kingdom

Location

MeSH Terms

Conditions

Anxiety Disorders; Depression; Parasomnias

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Guy W Fincham, MSc

  University of Sussex

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Guy William Fincham

Study Record Dates

• First Submitted: December 14, 2022
• First Posted: January 9, 2023
• Study Start: February 22, 2023
• Primary Completion: April 26, 2023
• Study Completion: April 26, 2023
• Last Updated: May 15, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Time Frame: Indefinitely after the study has been completed.
• Access Criteria: 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.

Locations

GB (1)