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Clinical Trials/NCT05676658
NCT05676658
Completed
Not Applicable

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

University of Sussex1 site in 1 country400 target enrollmentFebruary 22, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stress
Sponsor
University of Sussex
Enrollment
400
Locations
1
Primary Endpoint
Subjective stress
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 22, 2023
End Date
April 26, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Guy Fincham

Guy William Fincham

University of Sussex

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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

  • Self-reported credibility and expectancy of protocol(Immediately after starting breathwork intervention)
  • 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))
  • Self-reported adherence to protocol(Post-intervention (immediately 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))

Study Sites (1)

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