StressNCT05676658
Effects of Coherent Breathing Breathwork on Health
A study testing Coherent breathing in people with Stress and Anxiety, run by University of Sussex at 1 site in United Kingdom.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stress, Anxiety, Depressive Symptoms
- What is being tested?
- Coherent breathing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 22 Feb 2023to 26 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Coherent Breathing Breathwork on Mental Health and Wellbeing: A Randomised Placebo-controlled Study
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
- Being tested
- Coherent breathing, Placebo coherent breathing
- Medical subject headings
- Anxiety Disorders, Depression, Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coherent breathingBehavioural
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 coherent breathingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Coherent breathing | Experimental | Not described Receives: Behavioral: Coherent breathing |
| Placebo coherent breathing | Placebo comparator | Not described Receives: Behavioral: Placebo coherent breathing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
DASS-21 - anxiety subscale (score range: 0-21; higher scores denote worse outcome)
Measured: Pre-post intervention and follow-up (immediately before the intervention, immediately after the intervention, and four weeks after the intervention)
Subjective depressive symptoms
DASS-21 - depression subscale (score range: 0-21; higher scores denote worse outcome)
Measured: Pre-post intervention and follow-up (immediately before the intervention, immediately after the intervention, and four weeks after the intervention)
Subjective wellbeing
The World Health Organisation-5 Well-Being Index (WHO-5) (score range: 0-25; higher scores denote better outcome)
Measured: Pre-post intervention and follow-up (immediately before the intervention, immediately after the intervention, and four weeks after the intervention)
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
Measured: 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
Number of sessions participants self-report practicing out of 28 days assigned
Measured: Post-intervention (immediately after the intervention)
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
Measured: Immediately after starting breathwork intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2023
- Study start22 Feb 2023
- Primary completion26 Apr 2023
- Study completion26 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sussex
- Sponsor type
- University, hospital or other
- Collaborators
- Sylff Association
- Responsible party
- Principal investigator, Guy Fincham, University of Sussex
- Investigators
- Guy W Fincham, MSc, Principal investigator, University of Sussex
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05676658
- Sponsor's protocol ID
- Sussex coherent breath study
- Status last verified
- May 2023
- First submitted
- 14 Dec 2022
- Last updated
- 15 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Coherent Breathing Breathwork on Mental Health and Wellbeing: A Randomised Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT05676658
- Acronym / sponsor ID
- Sussex coherent breath study
- Conditions
- Stress, Anxiety, Depressive Symptoms, Wellbeing, Sleep Disturbance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- University of SussexUniversity, hospital or other
- Collaborators
- Sylff Association
- Study start
- 22 Feb 2023 (actual)
- Primary completion
- 26 Apr 2023 (actual)
- Study completion
- 26 Apr 2023 (actual)
- First posted
- 9 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Coherent breathing | Experimental | Behavioral: Coherent breathing |
| Placebo coherent breathing | Placebo comparator | Behavioral: Placebo coherent breathing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coherent breathingGuided 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. | Behavioural | Coherent breathing |
| Placebo coherent breathingSame 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. | Behavioural | Placebo coherent breathing |
Primary outcome
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
6 secondary outcomes
Subjective anxiety
Time frame: Pre-post intervention and follow-up (immediately before the intervention, immediately after the intervention, and four weeks after the intervention)
Subjective depressive symptoms
Time frame: Pre-post intervention and follow-up (immediately before the intervention, immediately after the intervention, and four weeks after the intervention)
Subjective wellbeing
Time frame: Pre-post intervention and follow-up (immediately before the intervention, immediately after the intervention, and four weeks after the intervention)
Subjective sleep disturbance
Time frame: 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
Time frame: Post-intervention (immediately after the intervention)
Self-reported credibility and expectancy of protocol
Time frame: Immediately after starting breathwork intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2023.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guy W Fincham, MSc principal investigator
University of Sussex
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coherent breathing in people with Stress and Anxiety, run by University of Sussex at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2023.