Effects of Coherent Breathing Breathwork on Health

Not Applicable

Completed

• Conditions: Stress; Anxiety; Wellbeing; Sleep Disturbance; Depressive Symptoms
• Interventions: Behavioral: Placebo coherent breathing; Behavioral: Coherent breathing

• Registration Number: NCT05676658
• Lead Sponsor: University of Sussex

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-12-14
• Study First Submitted QC: 2023-01-04
• Study First Posted: 2023-01-09
• Study Start: 2023-02-22
• Primary Completion: 2023-04-26
• Study Completion: 2023-04-26
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-11
• Last Update Posted: 2023-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo coherent breathing	Placebo coherent breathing	-
Coherent breathing	Coherent breathing	-

Primary Outcome Measures

Name	Time	Method
Subjective stress	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 Outcome Measures

Name	Time	Method
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)
Self-reported credibility and expectancy of protocol	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
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)
Subjective wellbeing	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)
Self-reported adherence to protocol	Post-intervention (immediately after the intervention)	Number of sessions participants self-report practicing out of 28 days assigned
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). Data scored using a T-score transformation according to PROMIS Sleep scoring manual on: www.healthmeasures.net

Trial Locations

Locations (1)

Prolific; 🇬🇧 Remote/Online, United Kingdom