Breathwork Intervention for Individuals With Post-Traumatic Stress Symptoms
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 4
- 主要终点
- Acceptability of Intervention Measure (AIM)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(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.
排除标准
- •(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
研究组 & 干预措施
Active Treatment
All participants will be assigned to breathwork.
干预措施: Breathwork (Behavioral)
结局指标
主要结局
Acceptability of Intervention Measure (AIM)
时间窗: Administered once at the conclusion of the in-person integration session (approx. 30 minutes post-intervention)
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.
Intervention Appropriateness Measure (IAM)
时间窗: Administered once at the conclusion of the in-person integration session (approx. 30 minutes post-intervention)
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.
Feasibility of Intervention Measure (FIM)
时间窗: Administered once at the conclusion of the in-person integration session (approx. 30 minutes post-intervention)
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.
Recruitment Feasibility
时间窗: From date of first participant contact (May 6th) to the day before the final breathwork session (10th of October): 158 days
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.
Retention
时间窗: From baseline assessment (-2 weeks) to 13-week follow-up: 15 week span
≥80% of enrolled participants completing all study procedures through final follow-up.
Acceptability of Intervention Measure (AIM)
时间窗: Administered once at the conclusion of the in-person integration session (approx. 30 minutes post-intervention)
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.
Intervention Appropriateness Measure (IAM)
时间窗: Administered once at the conclusion of the in-person integration session (approx. 30 minutes post-intervention)
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.
Feasibility of Intervention Measure (FIM)
时间窗: Administered once at the conclusion of the in-person integration session (approx. 30 minutes post-intervention)
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.
Acupuncture Expectancy Scale (AES)
时间窗: Administered once at the conclusion of the in-person integration session (approx. 30 minutes post-intervention)
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.
次要结局
- 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)
- Nondual Awareness Dimensional Assessment (NADA-State)(From immediately before to immediately after the in-person breathwork session (approximately 2-hour span); and from immediately before to immediately after each optional virtual follow-up session.)
- Emotional Breakthrough Inventory (EBI)(From immediately before to immediately after the in-person breathwork session (approximately 2-hour span); and from immediately before to immediately after each optional virtual follow-up session.)
- Perceived Body Boundary Scale (PBBS)(From immediately before to immediately after the in-person breathwork session (approximately 2-hour span); and from immediately before to immediately after each optional virtual follow-up session.)
- PROMIS Sleep Disturbance 6a + Sleep Duration(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)
- Patient Global Impression of Change (PGIC)(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)
- Pain, Enjoyment of Life, and General Activity Scale (PEG)(Baseline (-2 weeks), 4-week follow up, 8-week follow up and 13-week follow-up: 15 week span)
- Inclusion of Other in Self Scale (IOS)(From immediately before to immediately after the in-person breathwork session (approximately 2-hour span); and from immediately before to immediately after each optional virtual follow-up session.)
- Nondual Awareness Dimensional Assessment-Trait (NADA-T)(From immediately before to immediately after the in-person breathwork session (approximately 2-hour span); and from immediately before to immediately after each optional virtual follow-up session.)
- Integration Engagement Scale (IES)(4-week follow up, 8-week follow up and 13-week follow-up)
- Experienced Integration Scale (EIS)(4-week follow up, 8-week follow up and 13-week follow-up)
- Whole Person Health Index(4-week follow up, 8-week follow up and 13-week follow-up)
- Single-Item State Relaxation Measure(From immediately before to immediately after the in-person breathwork session (approximately 2-hour span); and from immediately before to immediately after each optional virtual follow-up session.)
- Brief Trauma Questionnaire (BTQ)(Baseline (-2 weeks), 4-week follow up, 8-week follow up and 13-week follow-up: 15 week span)
- 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)
- 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)
- Pain, Enjoyment of Life, and General Activity Scale (PEG)(Baseline (-2 weeks), 4-week follow up, 8-week follow up and 13-week follow-up: 15 week span)
- PROMIS Sleep Disturbance 6a + Sleep Duration(Baseline (-2 weeks), 4-week follow up, 8-week follow up and 13-week follow-up: 15 week span)
- PROMIS v1.0 Alcohol Use - Short Form 7a(Baseline (-2 weeks), 4-week follow up, 8-week follow up and 13-week follow-up: 15 week span)
- Smoking: Nicotine Dependence for All Smokers - Short Form 4a(Baseline (-2 weeks), 4-week follow up, 8-week follow up and 13-week follow-up: 15 week span)
- Patient Global Impression of Change (PGIC)(Baseline (-2 weeks), 4-week follow up, 8-week follow up and 13-week follow-up: 15 week span)
- Nondual Awareness Dimensional Assessment (NADA-State)(From immediately before to immediately after the in-person breathwork session (approximately 2-hour span); and from immediately before to immediately after each optional virtual follow-up session.)
- Emotional Breakthrough Inventory (EBI)(From immediately before to immediately after the in-person breathwork session (approximately 2-hour span); and from immediately before to immediately after each optional virtual follow-up session.)
- Perceived Body Boundary Scale (PBBS)(From immediately before to immediately after the in-person breathwork session (approximately 2-hour span); and from immediately before to immediately after each optional virtual follow-up session.)
- Spatial Frame of Reference Continuum (SFoRC)(From immediately before to immediately after the in-person breathwork session (approximately 2-hour span); and from immediately before to immediately after each optional virtual follow-up session.)
- Inclusion of Other in Self Scale (IOS)(From immediately before to immediately after the in-person breathwork session (approximately 2-hour span); and from immediately before to immediately after each optional virtual follow-up session.)
- Nondual Awareness Dimensional Assessment-Trait (NADA-T)(From immediately before to immediately after the in-person breathwork session (approximately 2-hour span); and from immediately before to immediately after each optional virtual follow-up session.)
- Integration Engagement Scale (IES)(4-week follow up, 8-week follow up and 13-week follow-up)
- Experienced Integration Scale (EIS)(4-week follow up, 8-week follow up and 13-week follow-up)
- Whole Person Health Index(4-week follow up, 8-week follow up and 13-week follow-up)
- Single-Item State Anxiety Measure(From immediately before to immediately after the in-person breathwork session (approximately 2-hour span); and from immediately before to immediately after each optional virtual follow-up session.)
- Brief Inventory of Psychosocial Functioning (B-IPF)(Baseline (-2 weeks), 4-week follow up, 8-week follow up and 13-week follow-up: 15 week span)
- Single-Item State Optimism Measure(From immediately before to immediately after the in-person breathwork session (approximately 2-hour span); and from immediately before to immediately after each optional virtual follow-up session.)
- Single-Item State Relaxation Measure(From immediately before to immediately after the in-person breathwork session (approximately 2-hour span); and from immediately before to immediately after each optional virtual follow-up session.)
研究者
Adam Hanley
Licensed Psychologist and an Associate Professor
Florida State University