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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Treatment | Experimental | All participants will be assigned to breathwork. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Breathwork | Behavioral | Participants will complete their single-session, 2-hour training in a small group with the Breathwork instructor. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Post-Traumatic Stress Disorder Checklist for DSM-5 (PCL-5) | The PCL-5 is a 20-item self-report measure. It is scored by summing the ratings for each of the 20 items. Each item is rated on a 5-point scale (0-4), where 0 means "Not at all" and 4 means "Extremely". The total score, ranging from 0 to 80, represents the severity of PTSD symptoms. | Baseline (-2 weeks), 4-week follow up, 8-week follow up and 13-week follow-up: 15 week span |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Diamond Rose Sanctuary | Branford | Connecticut | 06405 | United States | ||
| Florida State University |
Data may be shared with qualified researchers upon request.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Apr 16, 2025 | Apr 28, 2025 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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| 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) |
| Brief Trauma Questionnaire (BTQ) | The BTQ is a 10-item instrument that lists a number of difficult of stressful things that sometimes happen to people. The Brief Trauma Questionnaire (BTQ) is scored by counting the number of traumatic events experienced that meet DSM-IV "Criterion A" criteria (life threat or serious injury). Each of the 10 items on the BTQ is scored as positive if the respondent reports experiencing the event and also reports either life threat or serious injury (depending on the specific question). A higher score indicates a greater number of traumatic events experienced | Baseline (-2 weeks), 4-week follow up, 8-week follow up and 13-week follow-up: 15 week span |
| Posttraumatic Growth Inventory (PGI) | Posttraumatic growth will be assessed with the 21-item Posttraumatic Growth Inventory (PGI). It is scored by summing responses to its 21 items, each rated on a 6-point Likert scale. The total score ranges from 0 to 105, with higher scores indicating greater perceived post-traumatic growth. Scores on the five subscales (Relating to Others, New Possibilities, Personal Strength, Spiritual Change, and Appreciation of Life) are calculated by averaging the relevant items within each subscale. | 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) | The Patient Health Questionnaire 2-item (PHQ-2) is scored by summing the responses to its two questions. Each question offers four possible responses, scored from 0 to 3, with 0 being "not at all" and 3 being "nearly every day". A total score is calculated by adding the scores of both questions, resulting in a range from 0 to 6. A score of 3 or higher suggests further evaluation for depression | Baseline; 2-week follow up; 6-week follow up. |
| Generalized Anxiety Disorder-2 (GAD-2) | Patients will note their anxiety with the Generalized Anxiety Disorder-2 (GAD-2). This 2-item scale is scored by summing the responses to two questions, each rated on a 4-point scale. The possible scores for each item range from 0 to 3, with 0 representing "Not at all" and 3 representing "Nearly every day". The total score, which ranges from 0 to 6, is then calculated by adding the scores of the two items. A higher score indicates a greater likelihood of anxiety. | 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) | Participants will be asked about their pain intensity and pain interference with the Pain, Enjoyment of Life and General Activity (PEG) Scale. The 11-item Likert scale is scored by averaging the responses to three questions, each rated on a scale of 0 to 10. A higher score indicates a greater impact of pain. | 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 | The PROMIS Sleep Disturbance 6a and Sleep Duration measures are scored by first summing the responses to the individual items, then converting the raw sum score to a standardized T-score using conversion tables. The PROMIS Sleep Disturbance 6a uses a 5-point Likert scale for each item, and the Sleep Duration is a separate item with its own scoring. The T-score represents the individual's sleep disturbance relative to a reference population (mean of 50, standard deviation of 10). | 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 | The PROMIS v1.0 Alcohol Use - Short Form 7a is a 7-item questionnaire using a 5-point Likert scale (1- never to 5- almost always). It is scored by summing the responses to each question, where each question has a 5-point Likert scale. Higher scores indicate stronger positive expectancies about alcohol use. The raw score is then converted to a T-score for comparison with a normative sample. | 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 | The Smoking: Nicotine Dependence for All Smokers - Short Form 4a is a 4-item questionnaire using a 5-point Likert scale (1-never, 5-always). The Smoking: Nicotine Dependence for All Smokers - Short Form 4a is scored by summing the values of the responses to each of its four items. Each item has five possible response options, ranging from 1 to 5, with higher scores indicating greater nicotine dependence. The total raw score ranges from 4 (lowest dependence) to 20 (highest dependence). | 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) | The PGIC is a single-item, seven-point scale used to assess a patient's perception of change in their condition since a specific point in time. The scale ranges from "very much worse" to "very much improved". Higher scores indicate greater improvement, while lower scores indicate worsening or no change. | 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) | Participants will complete the 3-item, state version of the Nondual Awareness Dimensional Assessment. The NADA is scored 0-10 and responses are averaged across the 3-items. A higher score is indicative of a greater self-transcendent 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) | The Emotional Breakthrough Inventory is a 6-item questionnaire to assess emotional breakthrough resulting from an experience. It is scored 0-10 and scores are summed, with a higher score being indicative of a greater emotional breakthrough. | 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) | The Perceived Body Boundary Scale is a single visual item used to assess the strength of the boundary between the self and the world using a 7-point Likert type scale (1=Weak boundary, 7=Strong boundary). | 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) | The single-item Spatial Frame of Reference Continuum describes a spectrum of ways individuals and organisms represent and interact with spatial information, ranging from response A (self-centered (egocentric)) to response G (world-centered (allocentric) perspectives). Response G indicates the highest level of world-centered perspective. | 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) | The Inclusion of Other in Self (IOS) is a single-item scale. It is scored by having the respondent select one of seven pairs of overlapping circles that best represents their relationship with another person or group. Each pair of circles represents a different level of overlap, from completely separate (1) to almost completely overlapping (7). The chosen number (1-7) serves as the score, indicating the degree of perceived closeness and interconnectedness. | 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) | The 13-item Nondual Awareness Dimensional Assessment-Trait (NADA-T) will be used to assess traits of consciousness. The Nondual Awareness Dimensional Assessment-Trait (NADA-T) is scored by summing responses to 13 items, each on a 5-point Likert scale, ranging from "never or very rarely" to "very often or always". The scale assesses two dimensions of nondual awareness: self-transcendence and bliss. The total score can range from 13 to 65, with higher scores indicating a greater experience of nondual awareness. | 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) | The Integration Engagement Scale is a 12-item questionnaire used to measure positive behavioral engagement with integration. Participants are asked to rate their experiences on a 5-point Likert scale (0 = not at all to 4 = extremely). The IES yields a total score, typically ranging from 0 to 60. Higher scores on the IES generally indicate increased positive behavioral engagement with integration. | 4-week follow up, 8-week follow up and 13-week follow-up |
| Experienced Integration Scale (EIS) | The Experienced Integration Scale is a 12-item questionnaire to capture internal aspects of feeling integrated. Participants are asked to rate their experiences on a 5-point Likert scale (1- strongly disagree to 5=strongly agree). Items are summed; a higher score indicates greater feelings of integration. | 4-week follow up, 8-week follow up and 13-week follow-up |
| Whole Person Health Index | The Whole Person Health Index (WPHI) is a 9-item survey. It is scored by The WPHI can be calculated by summing the nine response scores, such that, over time, for example, an individual's WPHI going from 45 to 25 would indicate an improvement in overall self-assessed health | 4-week follow up, 8-week follow up and 13-week follow-up |
| Brief Inventory of Psychosocial Functioning (B-IPF) | Psychosocial functioning will be assessed using the Brief Inventory of Psychosocial Functioning (B-IPF), a validated 7-item self-report instrument designed to measure psychosocial impairment across key life domains. Each item is rated on a 7-point Likert scale ranging from 0 ("Not at all") to 6 ("Very much"), with higher scores indicating greater psychosocial impairment. The total score is calculated by summing responses across all items, yielding a possible range of 0 to 42. Sample item: "I had trouble in my romantic relationship with my spouse or partner. | Baseline (-2 weeks), 4-week follow up, 8-week follow up and 13-week follow-up: 15 week span |
| Single-Item State Anxiety Measure | State anxiety will be measured using a single item adapted from the Generalized Anxiety Disorder 2-item (GAD-2) scale: "Right now, to what extent are you feeling… nervous, anxious, or on edge?" Participants respond using a 7-point Likert scale ranging from 0 ("Not at all") to 6 ("Extremely"), with higher scores indicating greater state anxiety. | 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 Optimism Measure | State optimism will be assessed using a single item adapted from the State Optimism Measure: "Right now, to what extent are you feeling… optimistic about life's challenges?" Participants respond using a 7-point Likert scale ranging from 0 ("Not at all") to 6 ("Extremely"), with higher scores indicating greater state optimism. | 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 | State relaxation will be measured using a single item adapted from the Relaxation State Questionnaire: "Right now, to what extent are you feeling… refreshed and awake?" Participants respond using a 7-point Likert scale ranging from 0 ("Not at all") to 6 ("Extremely"), with higher scores indicating greater relaxation or alertness. | 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. |
| Tallahassee |
| Florida |
| 32306 |
| United States |