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Effects of Coherent Breathing Breathwork on Health

Primary Purpose

Stress, Anxiety, Depressive Symptoms

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Coherent breathing
Placebo coherent breathing
Sponsored by
University of Sussex
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Prolific

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Coherent breathing

Placebo coherent breathing

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Subjective anxiety
DASS-21 - anxiety subscale (score range: 0-21; higher scores denote worse outcome)
Subjective depressive symptoms
DASS-21 - depression subscale (score range: 0-21; higher scores denote worse outcome)
Subjective wellbeing
The World Health Organisation-5 Well-Being Index (WHO-5) (score range: 0-25; higher scores denote better outcome)
Subjective sleep disturbance
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
Self-reported adherence to protocol
Number of sessions participants self-report practicing out of 28 days assigned
Self-reported credibility and expectancy of protocol
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

Full Information

First Posted
December 14, 2022
Last Updated
May 11, 2023
Sponsor
University of Sussex
Collaborators
Sylff Association
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1. Study Identification

Unique Protocol Identification Number
NCT05676658
Brief Title
Effects of Coherent Breathing Breathwork on Health
Official Title
Effects of Coherent Breathing Breathwork on Mental Health and Wellbeing: A Randomised Placebo-controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
February 22, 2023 (Actual)
Primary Completion Date
April 26, 2023 (Actual)
Study Completion Date
April 26, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sussex
Collaborators
Sylff Association

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress, Anxiety, Depressive Symptoms, Wellbeing, Sleep Disturbance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
400 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Coherent breathing
Arm Type
Experimental
Arm Title
Placebo coherent breathing
Arm Type
Placebo Comparator
Intervention Type
Behavioral
Intervention Name(s)
Coherent breathing
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Placebo coherent breathing
Intervention Description
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 Outcome Measure Information:
Title
Subjective stress
Description
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
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
Secondary Outcome Measure Information:
Title
Subjective anxiety
Description
DASS-21 - anxiety subscale (score range: 0-21; higher scores denote worse outcome)
Time Frame
Pre-post intervention and follow-up (immediately before the intervention, immediately after the intervention, and four weeks after the intervention)
Title
Subjective depressive symptoms
Description
DASS-21 - depression subscale (score range: 0-21; higher scores denote worse outcome)
Time Frame
Pre-post intervention and follow-up (immediately before the intervention, immediately after the intervention, and four weeks after the intervention)
Title
Subjective wellbeing
Description
The World Health Organisation-5 Well-Being Index (WHO-5) (score range: 0-25; higher scores denote better outcome)
Time Frame
Pre-post intervention and follow-up (immediately before the intervention, immediately after the intervention, and four weeks after the intervention)
Title
Subjective sleep disturbance
Description
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
Time Frame
Pre-post intervention and follow-up (immediately before the intervention, immediately after the intervention, and four weeks after the intervention)
Title
Self-reported adherence to protocol
Description
Number of sessions participants self-report practicing out of 28 days assigned
Time Frame
Post-intervention (immediately after the intervention)
Title
Self-reported credibility and expectancy of protocol
Description
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
Time Frame
Immediately after starting breathwork intervention
Other Pre-specified Outcome Measures:
Title
Overall experience
Description
Optional open-ended questions on participants' perspectives and overall experience of the protocol/study-period
Time Frame
Post-intervention and follow-up (immediately after the intervention, and four weeks after the intervention)
Title
Impairment of practice
Description
Optional open-ended question on whether anything impaired participants' ability to perform their randomly allocated breathwork
Time Frame
Post-intervention (immediately after the intervention)
Title
Hypothesis guessing
Description
Optional open-ended question on whether participants can guess the hypothesis of the study
Time Frame
Follow-up (four weeks after the intervention)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guy W Fincham, MSc
Organizational Affiliation
University of Sussex
Official's Role
Principal Investigator
Facility Information:
Facility Name
Prolific
City
Remote/Online
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All participant data will be anonymous (only Prolific user IDs will be seen). No identifiable personal information will be collected. Participants will be able to check a box if they are happy for our research team at the University of Sussex to include the data again in future studies related to breathwork and meditation if these have gained independent ethically approval, based on the strict confidentiality terms described in the participant info/consent form.
IPD Sharing Time Frame
Indefinitely after the study has been completed.
IPD Sharing 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.

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Effects of Coherent Breathing Breathwork on Health

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