NCT06374810

Brief 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. 1.Does conscious connected breathwork reduce symptoms of anxiety?
  2. 2.Does an increased frequency of self-practice lead to even greater reductions of anxiety symptoms.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P50-P75 for not_applicable anxiety

Timeline
Completed

Started Sep 2023

Shorter than P25 for not_applicable anxiety

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 21, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 16, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 19, 2024

Completed
Last Updated

April 22, 2024

Status Verified

April 1, 2024

Enrollment Period

3 months

First QC Date

April 16, 2024

Last Update Submit

April 18, 2024

Conditions

Keywords

anxiety

Outcome Measures

Primary Outcomes (1)

  • 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.

    6 - 8 weeks between taking the anxiety scale either before and after the breathwork program or remaining on the wait list

Study Arms (2)

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

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.

Other: Placebo waitlist

Interventions

Participants were taught the Conscious Connected Breathwork Technique. 2 facilitators were monitoring and coaching the participants to ensure adherence to the technique

Breathwork Group

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

Waitlist control group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- Scores of 35 or higher on the Zung self-rating anxiety scale

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CIIS

San Francisco, California, 94103, United States

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants in group 2 were told that the trial was full but actually they were just placed in the placebo control group.
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PhD Candidate

Study Record Dates

First Submitted

April 16, 2024

First Posted

April 19, 2024

Study Start

September 21, 2023

Primary Completion

December 20, 2023

Study Completion

December 20, 2023

Last Updated

April 22, 2024

Record last verified: 2024-04

Locations