AnxietyNCT06374810
Does Conscious Connected Breathwork Reduce Symptoms of Anxiety?
A study testing Conscious Connected Breathwork in people with Anxiety, run by Richard Blake at 1 site in United States.
Trial summary
The goal of this clinical trial is to test whether conscious connected breathwork reduces symptoms of anxiety in people with mild to severe anxiety symptoms, as measured by the Zung Self Rating Anxiety Scale. The main questions aims to answer: 1. Does conscious connected breathwork reduce symptoms of anxiety? 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety
- What is being tested?
- Conscious Connected Breathwork
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Sep 2023to 20 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Scores of 35 or higher on the Zung self-rating anxiety scale
Who cannot join
- anyone having completed more than 4 sessions of Conscious Connected Breathwork
- Anyone who has recently (within 1 year) started anti-depressant medication or psychotherapy
- Anyone with a history of panic disorder, psychosis, angina, pregnant, seizure disorder, glaucoma
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does Conscious Connected Breathwork Reduces Symptoms of Anxiety. A Quantitative Study Conducted in an Online Environment
The goal of this clinical trial is to test whether conscious connected breathwork reduces symptoms of anxiety in people with mild to severe anxiety symptoms, as measured by the Zung Self Rating Anxiety Scale.
The main questions aims to answer:
Read more
- Does conscious connected breathwork reduce symptoms of anxiety?
- Does an increased frequency of self-practice lead to even greater reductions of anxiety symptoms. there is a comparison group: Researchers will compare whether people doing the breathwork to see if [insert effects].
Participants will participate in 1, 90 minute breath workshop per week for 6 weeks. These sessions will be held on Zoom by 2 facilitators. Participants will also be given a 10 minute recording of a guided conscious connected breathwork session that they will be encouraged to complete daily.
- Conditions
- Anxiety
- Being tested
- Conscious Connected Breathwork, Placebo waitlist
- Keywords
- anxiety
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conscious Connected BreathworkBehavioural
Participants were taught the Conscious Connected Breathwork Technique. 2 facilitators were monitoring and coaching the participants to ensure adherence to the technique
Placebo waitlistOther
Participants were told the study was full and that they were placed on a waiting list until the 1st cohort had completed the breathwork program
| Study group | Role | What they receive |
|---|---|---|
| Breathwork Group | Experimental | This group participated in 6 weeks of 90-minute Conscious Connected Breathwork groups conducted via Zoom. Participants attended 1 workshop per week Receives: Behavioral: Conscious Connected Breathwork |
| Waitlist control group | Placebo comparator | This group were told the 1st cohort of the study was full and they would be permitted to join cohort 2 in 6 weeks time. At the end of this waitlist period participants were invited to join the second cohort so long as they still met the inclusion criteria. Receives: Other: Placebo waitlist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in anxiety symptoms
Scores on the Zung Self Rating Anxiety Scale - Scores range from a minimum of 20 and a maximum of 80. A higher score indicates more severe symptoms of anxiety than a lower score.
Measured: 6 - 8 weeks between taking the anxiety scale either before and after the breathwork program or remaining on the wait list
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2024
- Study start21 Sep 2023
- Primary completion20 Dec 2023
- Study completion20 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies 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
- Crossover
- Model description
- Participants were randomly assigned to either the breathwork group or they were told that they had been placed on a waitlist and that they would participate in the 2nd cohort, which would take place after the 1st 6-week program had been completed. Participants in the breathwork groups were also given a 10 minute guided conscious connected breathwork recording. They were advised to do this daily to support the integration of their process. This was not mandatory. At the end of the study participants were asked how often they used the guided self-practice. The frequency of use of the self-practice was used a covariate.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Richard Blake
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Richard Blake, California Institute of Integral Studies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06374810
- Sponsor's protocol ID
- CCB1
- Status last verified
- Apr 2024
- First submitted
- 16 Apr 2024
- Last updated
- 22 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Conscious Connected Breathwork Reduces Symptoms of Anxiety. A Quantitative Study Conducted in an Online Environment
- ClinicalTrials.gov ID
- NCT06374810
- Acronym / sponsor ID
- CCB1
- Conditions
- Anxiety
- Keywords
- anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Richard BlakeUniversity, hospital or other
- Study start
- 21 Sep 2023 (actual)
- Primary completion
- 20 Dec 2023 (actual)
- Study completion
- 20 Dec 2023 (actual)
- First posted
- 19 Apr 2024 (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 goal of this clinical trial is to test whether conscious connected breathwork reduces symptoms of anxiety in people with mild to severe anxiety symptoms, as measured by the Zung Self Rating Anxiety Scale.
The main questions aims to answer:
- Does conscious connected breathwork reduce symptoms of anxiety?
- Does an increased frequency of self-practice lead to even greater reductions of anxiety symptoms. there is a comparison group: Researchers will compare whether people doing the breathwork to see if [insert effects].
Participants will participate in 1, 90 minute breath workshop per week for 6 weeks. These sessions will be held on Zoom by 2 facilitators. Participants will also be given a 10 minute recording of a guided conscious connected breathwork session that they will be encouraged to complete daily.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants were randomly assigned to either the breathwork group or they were told that they had been placed on a waitlist and that they would participate in the 2nd cohort, which would take place after the 1st 6-week program had been completed. Participants in the breathwork groups were also given a 10 minute guided conscious connected breathwork recording. They were advised to do this daily to support the integration of their process. This was not mandatory. At the end of the study participants were asked how often they used the guided self-practice. The frequency of use of the self-practice was used a covariate.
| Arm | Type | Receives |
|---|---|---|
| Breathwork Group | Experimental | Behavioral: Conscious Connected BreathworkThis group participated in 6 weeks of 90-minute Conscious Connected Breathwork groups conducted via Zoom. Participants attended 1 workshop per week |
| Waitlist control group | Placebo comparator | Other: Placebo waitlistThis group were told the 1st cohort of the study was full and they would be permitted to join cohort 2 in 6 weeks time. At the end of this waitlist period participants were invited to join the second cohort so long as they still met the inclusion criteria. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Scores of 35 or higher on the Zung self-rating anxiety scale
Key exclusion criteria (3 listed)
- anyone having completed more than 4 sessions of Conscious Connected Breathwork
- Anyone who has recently (within 1 year) started anti-depressant medication or psychotherapy
- Anyone with a history of panic disorder, psychosis, angina, pregnant, seizure disorder, glaucoma
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 |
|---|---|---|
| Conscious Connected BreathworkParticipants were taught the Conscious Connected Breathwork Technique. 2 facilitators were monitoring and coaching the participants to ensure adherence to the technique | Behavioural | Breathwork Group |
| Placebo waitlistParticipants were told the study was full and that they were placed on a waiting list until the 1st cohort had completed the breathwork program | Other | Waitlist control group |
Primary outcome
Changes in anxiety symptoms
Time frame: 6 - 8 weeks between taking the anxiety scale either before and after the breathwork program or remaining on the wait list
Scores on the Zung Self Rating Anxiety Scale - Scores range from a minimum of 20 and a maximum of 80. A higher score indicates more severe symptoms of anxiety than a lower score.
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 22 Apr 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conscious Connected Breathwork in people with Anxiety, run by Richard Blake at 1 site in United States.
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 1 inclusion and 3 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 22 Apr 2024. 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 States. 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?
Changes in anxiety symptoms (time frame: 6 - 8 weeks between taking the anxiety scale either before and after the breathwork program or remaining on the wait list). 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 22 Apr 2024.