StressNCT06064474
Effects of High Ventilation Breathwork With Retention (HVBR) on Health
A study testing High ventilation breathwork with retention (HVBR) 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 high ventilation breathwork with retention (HVBR) to a breathwork placebo (paced breathing at 15breaths/min with brief retentions). Read more about this study
- Who is it for?
- Ages 18 to 39 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress, Anxiety, Depressive Symptoms
- What is being tested?
- High ventilation breathwork with retention (HVBR)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 13 Oct 2023to 11 Dec 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 to 39 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Fluent in English and living in the UK
- Have access to headphones
- Comfortable with faster breathing and holding breath
- Willing to only practice breathwork in safe environment, lying down in soft area (i.e., bed, sofa, carpet/mat), and always away from water \& hard ground
- Willing to only practice the breathwork away from large meals (i.e., before or 1hour after) and bedtime (i.e., at least 1 hour before if practicing in evening)
Who cannot join
- Hypotension or hypertension (low or high blood pressure)
- History of respiratory or cardiovascular/heart problems or disease
- History of fainting or syncope
- Epilepsy or seizures
- History of panic disorder or panic attacks
- Cerebral aneurysm
Show all 11Show fewer
- Have had problems with prior breathwork sessions (i.e., fainting)
- Pregnancy, think one might be pregnant, trying to get pregnant, or are breastfeeding
- Any problems which affect one's ability to pace their breathing (i.e., active/chronic respiratory infection including blocked nose/cough/cold/fever, etc.), breathlessness, abnormally slow breathing (bradypnea), or abnormally fast breathing (tachypnoea)
- Any other physical/mental health conditions or current life events which impair or affect one's ability to engage in activities involving breath control
- Are taking any regular medication other than the contraceptive pill, including medications to reduce blood pressure (i.e., Ramipril or other ACE-inhibitors), beta blockers (i.e., Propranolol), antidepressants, anxiolytics or any other psychotropic medications
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of High Ventilation Breathwork With Retention (HVBR) on Mental Health and Wellbeing: A Randomised Placebo-controlled Trial
The investigators are conducting a randomised-controlled trial comparing high ventilation breathwork with retention (HVBR) to a breathwork placebo (paced breathing at 15breaths/min with brief retentions). The metric of 15b/min aligns with guidance from the British Journal of Nursing, Royal College of Physicians and Johns Hopkins Medicine which state that the average, healthy rate should range from: 12-20, 12-18 and 12-16b/min, respectively. The main questions the study attempts to address are: Does HVBR lead to improved state and trait 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 three-week breathwork period, in addition to a follow-up three weeks later. Pre-post intervention and follow-up questionnaires will be completed online via the survey platform Qualtrics which will be linked to Prolific. Data on self-reported adherence to, and credibility/expectancy of, the breathwork will also be collected, along with participants' experiences to gauge the safety and tolerability of the breathwork protocol.
- Conditions
- Stress, Anxiety, Depressive Symptoms, Mental Wellbeing, Positive Affect, Negative Affect
- Being tested
- High ventilation breathwork with retention (HVBR), Placebo HVBR
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High ventilation breathwork with retention (HVBR)Behavioural
Intervention
Placebo HVBRBehavioural
Placebo
| Study group | Role | What they receive |
|---|---|---|
| High ventilation breathwork with retention (HVBR) | Experimental | Guided audio of HVBR pre-recorded by a trained breathwork facilitator for ~20min/day over 21 days (three weeks). Delivered remotely through audio link, comprising evocative music and four rounds of hyperventilation with four separate retentions (breath holds), progressively increasing in length (from ~45seconds up to ~90 seconds). Receives: Behavioral: High ventilation breathwork with retention (HVBR) |
| Placebo HVBR | Placebo comparator | Guided audio of placebo HVBR pre-recorded by a trained breathwork facilitator for ~20min/day over 21 days (three weeks). Delivered remotely through audio link, comprising music and four rounds of paced breathing at 15b/min (equal inhale:exhale) with four separate brief retentions, progressively increasing in length (from ~10secs to ~25secs). Receives: Behavioral: Placebo HVBR |
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 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 three weeks after the intervention). Primary timepoint is post-intervention
Secondary outcomes (9)
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 three 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 three weeks after the intervention)
Subjective mental wellbeing
Short Warwick-Edinburgh Mental Wellbeing Scale (SWEMWBS) (score range: 7 to 35; higher scores denote better outcome). Total raw scores are then transformed into metric scores using the SWEMWBS conversion table on: www.warwick.ac.uk
Measured: Pre-post intervention and follow-up (immediately before the intervention, immediately after the intervention, and three weeks after the intervention)
Subjective sleep-related impairment
PROMIS Item Bank v. 1.0 - Sleep-Related Impairment - Short Form 4a (score range: 5-20; 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 three weeks after the intervention)
Subjective positive affect
Positive and Negative Affect Schedule (PANAS) positive affect subscale (score range: 10-50; higher scores denote better outcome)
Measured: Pre-intervention (immediately before the intervention), post first breathwork session (immediately after starting breathwork), and post-intervention (immediately after the intervention)
Subjective negative affect
PANAS negative affect subscale (score range: 10-50; higher scores denote worse outcome)
Measured: Pre-intervention (immediately before the intervention), post first breathwork session (immediately after starting breathwork), and post-intervention (immediately after the intervention)
Subjective 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%. Scores for expectancy set then standardised via converting them to z-scores. Higher scores denote greater credibility and/or expectancy of specific breathwork technique
Measured: Immediately after starting breathwork intervention
Negative side effects due to protocol
Whether participants experienced unpleasant/unwanted short-term effects and/or lasting bad effects from the breathwork
Measured: Post-intervention (immediately after the intervention)
Self-reported adherence to protocol
Number of sessions participants self-report practicing out of 21 days assigned
Measured: Post-intervention (immediately after the intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2023
- Study start13 Oct 2023
- Primary completion11 Dec 2023
- Study completion11 Dec 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
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sussex
- Sponsor type
- University, hospital or other
- Collaborators
- Sylff Association, Brighton & Sussex Medical School, University of California, San Francisco
- 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
- NCT06064474
- Sponsor's protocol ID
- Sussex fast breathwork study
- Status last verified
- Dec 2023
- First submitted
- 26 Sep 2023
- Last updated
- 20 Dec 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, as well as share with other research groups, if these have gained independent ethical 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 20 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of High Ventilation Breathwork With Retention (HVBR) on Mental Health and Wellbeing: A Randomised Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT06064474
- Acronym / sponsor ID
- Sussex fast breathwork study
- Conditions
- Stress, Anxiety, Depressive Symptoms, Mental Wellbeing, Positive Affect, Negative Affect
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University of SussexUniversity, hospital or other
- Collaborators
- Sylff Association, Brighton & Sussex Medical School, University of California, San Francisco
- Study start
- 13 Oct 2023 (actual)
- Primary completion
- 11 Dec 2023 (actual)
- Study completion
- 11 Dec 2023 (actual)
- First posted
- 3 Oct 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 high ventilation breathwork with retention (HVBR) to a breathwork placebo (paced breathing at 15breaths/min with brief retentions). The metric of 15b/min aligns with guidance from the British Journal of Nursing, Royal College of Physicians and Johns Hopkins Medicine which state that the average, healthy rate should range from: 12-20, 12-18 and 12-16b/min, respectively. The main questions the study attempts to address are: Does HVBR lead to improved state and trait 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 three-week breathwork period, in addition to a follow-up three weeks later. Pre-post intervention and follow-up questionnaires will be completed online via the survey platform Qualtrics which will be linked to Prolific. Data on self-reported adherence to, and credibility/expectancy of, the breathwork will also be collected, along with participants' experiences to gauge the safety and tolerability of the breathwork protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High ventilation breathwork with retention (HVBR) | Experimental | Behavioral: High ventilation breathwork with retention (HVBR)Guided audio of HVBR pre-recorded by a trained breathwork facilitator for ~20min/day over 21 days (three weeks). Delivered remotely through audio link, comprising evocative music and four rounds of hyperventilation with four separate retentions (breath holds), progressively increasing in length (from ~45seconds up to ~90 seconds). |
| Placebo HVBR | Placebo comparator | Behavioral: Placebo HVBRGuided audio of placebo HVBR pre-recorded by a trained breathwork facilitator for ~20min/day over 21 days (three weeks). Delivered remotely through audio link, comprising music and four rounds of paced breathing at 15b/min (equal inhale:exhale) with four separate brief retentions, progressively increasing in length (from ~10secs to ~25secs). |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Fluent in English and living in the UK
- Have access to headphones
- Comfortable with faster breathing and holding breath
- Willing to only practice breathwork in safe environment, lying down in soft area (i.e., bed, sofa, carpet/mat), and always away from water \& hard ground
- Willing to only practice the breathwork away from large meals (i.e., before or 1hour after) and bedtime (i.e., at least 1 hour before if practicing in evening)
Key exclusion criteria (11 listed)
- Hypotension or hypertension (low or high blood pressure)
- History of respiratory or cardiovascular/heart problems or disease
- History of fainting or syncope
- Epilepsy or seizures
- History of panic disorder or panic attacks
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 |
|---|---|---|
| High ventilation breathwork with retention (HVBR)Intervention | Behavioural | High ventilation breathwork with retention (HVBR) |
| Placebo HVBRPlacebo | Behavioural | Placebo HVBR |
Primary outcome
Subjective stress
Time frame: Pre-post intervention and follow-up (immediately before the intervention, immediately after the intervention, and three 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 then multiplied by two to convert it to the longer form DASS-42 final score
9 secondary outcomes
Subjective anxiety
Time frame: Pre-post intervention and follow-up (immediately before the intervention, immediately after the intervention, and three weeks after the intervention)
Subjective depressive symptoms
Time frame: Pre-post intervention and follow-up (immediately before the intervention, immediately after the intervention, and three weeks after the intervention)
Subjective mental wellbeing
Time frame: Pre-post intervention and follow-up (immediately before the intervention, immediately after the intervention, and three weeks after the intervention)
Subjective sleep-related impairment
Time frame: Pre-post intervention and follow-up (immediately before the intervention, immediately after the intervention, and three weeks after the intervention)
Subjective positive affect
Time frame: Pre-intervention (immediately before the intervention), post first breathwork session (immediately after starting breathwork), and post-intervention (immediately after the intervention)
Subjective negative affect
Time frame: Pre-intervention (immediately before the intervention), post first breathwork session (immediately after starting breathwork), and post-intervention (immediately after the intervention)
Subjective credibility and expectancy of protocol
Time frame: Immediately after starting breathwork intervention
Negative side effects due to protocol
Time frame: Post-intervention (immediately after the intervention)
Self-reported adherence to protocol
Time frame: Post-intervention (immediately after the 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 20 Dec 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, as well as share with other research groups, if these have gained independent ethical 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 High ventilation breathwork with retention (HVBR) 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 5 inclusion and 11 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 20 Dec 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 three 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 20 Dec 2023.