Breathwork Intervention for Posttraumatic Stress

NCT07129278 | Completed

• 1 other identifier: STUDY00005111
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this single-site, single-arm pilot study is to examine the impact of breathwork training for posttraumatic stress symptoms in an adult veteran population. Participants will complete a single, in-person breathwork session (2 hours) led by a certified breathwork facilitator and engage in an integration session (30 minute) with a licensed psychologist. Participants will be invited to engage in two, optional, virtual follow up breathwork sessions (40 minute practice each) during weeks 2 and 3 following the in-person breathwork session.

Conditions

PTSD

Keywords

PTSD; Breathwork; Contemplative practice; Cyclic sighing

Outcome Measures

Primary Outcomes (6)

• Recruitment Feasibility

  The primary outcome of recruitment feasibility will be assessed by the ability to enroll 30 eligible participants by September 30, 2025. This will inform the practicality of recruitment strategies for a future definitive trial.

  From date of first participant contact (May 6th) to the day before the final breathwork session (10th of October): 158 days

• Retention

  ≥80% of enrolled participants completing all study procedures through final follow-up.

  From baseline assessment (-2 weeks) to 13-week follow-up: 15 week span

• Acceptability of Intervention Measure (AIM)

  Acceptability of Intervention Measure (AIM) is a 4-item scale. It uses a 5-point ordinal scale for each item, ranging from "Completely Disagree" to "Completely Agree". Scores are typically calculated as either the mean or total of the responses, with higher scores indicating greater acceptability.

  Administered once at the conclusion of the in-person integration session (approx. 30 minutes post-intervention)

• Intervention Appropriateness Measure (IAM)

  Intervention Appropriateness Measure (IAM) is a 4-item scale. It uses a 5-point ordinal scale for each item, ranging from "Completely Disagree" to "Completely Agree". Scores are typically calculated as either the mean or total of the responses, with higher scores indicating greater appropriateness.

  Administered once at the conclusion of the in-person integration session (approx. 30 minutes post-intervention)

• Feasibility of Intervention Measure (FIM)

  Feasibility of Intervention Measure (FIM) is a 4-item scale. It uses a 5-point ordinal scale for each item, ranging from "Completely Disagree" to "Completely Agree". Scores are typically calculated as either the mean or total of the responses, with higher scores indicating greater feasibility.

  Administered once at the conclusion of the in-person integration session (approx. 30 minutes post-intervention)

• Acupuncture Expectancy Scale (AES)

  The Acupuncture Expectancy Scale (AES) is a 4-item scale. It uses a 5-point Likert scale for each item, and a higher total score (ranging from 4 to 20) indicates greater expectancy of benefit from acupuncture.

  Administered once at the conclusion of the in-person integration session (approx. 30 minutes post-intervention)

Secondary Outcomes (23)

• Post-Traumatic Stress Disorder Checklist for DSM-5 (PCL-5)

  Baseline (-2 weeks), 4-week follow up, 8-week follow up and 13-week follow-up: 15 week span

• Brief Trauma Questionnaire (BTQ)

  Baseline (-2 weeks), 4-week follow up, 8-week follow up and 13-week follow-up: 15 week span

• Posttraumatic Growth Inventory (PGI)

  Baseline (-2 weeks), 4-week follow up, 8-week follow up and 13-week follow-up: 15 week span

• Patient Health Questionnaire 2-item (PHQ-2)

  Baseline; 2-week follow up; 6-week follow up.

• Generalized Anxiety Disorder-2 (GAD-2)

  Baseline (-2 weeks), 4-week follow up, 8-week follow up and 13-week follow-up: 15 week span

Study Arms (1)

Active Treatment

EXPERIMENTAL

All participants will be assigned to breathwork.

Behavioral: Breathwork

Interventions

Breathwork BEHAVIORAL

Participants will complete their single-session, 2-hour training in a small group with the Breathwork instructor.

Active Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (1) having received a professional diagnosis of post-traumatic stress disorder (PTSD)
• (2) being able not to commit to another (new) treatment during the course of the study
• (3) understanding English instructions fluently
• (4) being 18 and above.

You may not qualify if:

• (1) having been exposed to breathwork any time in the past
• (2) being unable to perform most basic tasks due to PTSD or other mental illness.
• (3) Asthma, breathing problems, or a respiratory disorder (e.g., chronic obstructive pulmonary disease).
• (4) Uncontrolled hypertension (i.e., systolic blood pressure/diastolic blood pressure \> 150/95), orthostatic hypotension (e.g., issues with fainting), or cardiovascular or peripheral arterial disease.
• (5) Current or past diagnosis of a neurological disease (e.g., Parkinson's, multiple sclerosis, epilepsy, vasovagal syncope)
• (6) Serious psychiatric disorder requiring hospitalization within the past 12 months
• (7) Current substance use disorder or history of hospitalization for treatment of a substance use disorder.
• (8) Current participation in another research study involving an intervention or treatment.
• (9) Currently pregnant
• (10) Any significant comorbidities or issues that, in the opinion of the investigators, could interfere with the study or lead to deleterious effects for the participant.
• (11) Adults unable to consent
• (12) Prisoners

Sponsors & Collaborators

• Florida State University: lead

Study Sites (2)

Diamond Rose Sanctuary

Branford, Connecticut, 06405, United States

Location

Florida State University

Tallahassee, Florida, 32306, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Licensed Psychologist and an Associate Professor

Study Record Dates

• First Submitted: April 30, 2025
• First Posted: August 19, 2025
• Study Start: May 7, 2025
• Primary Completion: October 6, 2025
• Study Completion: October 6, 2025
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

US (2)