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This early-stage pilot trial aims to examine the feasibility, tolerability, and safety of Floatation-REST, or Reduced Environmental Stimulation Therapy via floatation in frontline healthcare workers, first responders, and emergency medical personnel who experience post-traumatic stress symptoms.
Frontline healthcare workers, first responders, and emergency medical personnel are repeatedly exposed to occupational stressors and potentially traumatic events, placing them at elevated risk for post-traumatic stress symptoms (PTSS), burnout, anxiety, and related impairments. Current stress-reduction approaches for healthcare workers often have limited evidence for efficacy or may be difficult to implement in high-demand emergency and healthcare settings. Therefore, rapid, low-burden interventions that are feasible, tolerable, and safe for this population are needed.
Floatation-REST, or Reduced Environmental Stimulation Therapy, is a non-pharmacological intervention that reduces sensory input to the nervous system through the act of floating supine in a pool of warm water saturated with Epsom salt. The float environment is designed to reduce visual, auditory, thermal, tactile, vestibular, and proprioceptive stimulation. Prior studies suggest that Floatation-REST may acutely reduce stress and anxiety-related symptoms, but it has not yet been systematically evaluated in frontline healthcare workers with elevated PTSS.
This single-site, double-arm pilot study will examine the feasibility, tolerability, and safety of two 60-minute sessions of Floatation-REST compared with a documentary-viewing condition in adults ages 18 to 64 with work-related post-traumatic stress symptoms. Up to 30 participants will be recruited, with the goal of retaining 15 completers randomized on a 2:1 basis to Floatation-REST versus comparator condition. Participants will complete two in-person study visits at the Laureate Institute for Brain Research, including self-report questionnaires, blood and saliva collection, functional magnetic resonance imaging scans, and either Floatation-REST or documentary viewing. Follow-up surveys will be completed virtually up to one week after final intervention session.
The primary aim is to evaluate the safety and tolerability of Floatation-REST in this population. Secondary aims will explore whether Floatation-REST is associated with acute changes in PTSS, perceived stress, anxiety, burnout, mood, mindfulness, and moral injury-related distress. Exploratory aims will examine whether changes in brain network connectivity, salivary cortisol, and blood-based proteomic markers may help explain symptom change. Results from this early-stage study will help determine whether Floatation-REST should be further studied as a potential intervention for post-traumatic stress symptoms in frontline healthcare and emergency personnel.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Floatation-REST | Experimental | Participants will float supine in a shallow pool for two one-hour sessions approximately seven days apart. |
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| Documentary Condition | Active Comparator | Participants will watch two one-hour documentaries in a relaxing environment approximately seven days apart. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Floatation-REST | Behavioral | Participants float supine in a shallow pool of water saturated with Epsom salt. The environment is designed to minimize external stimulation via multiple channels including sound, light, and temperature. |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse effects | Safety will be assessed using adverse events reported directly to study staff and adverse effects reported on the Floatation-REST effects checklist after each Floatation-REST or comparator session. As a proxy of safety, adverse effects will be calculated for each participant as the number of instances during the study in which the participant reports an increase above mild for any negatively experienced effect on the checklist. | From baseline to post-intervention seven day follow-up |
| Dropout Rate | As a proxy for tolerability, dropout rate for each arm = (# of subjects who are withdrawn from the study)/(# participants in specific arm). | Baseline through seven day post-intervention follow up |
| Measure | Description | Time Frame |
|---|---|---|
| Burnout Effects of Floatation-REST | Burnout measured using the MBI-HSS questionnaire after each experimental session and at follow-up time points | Baseline through seven day post-intervention follow up |
| Perceived Stress Effects of Floatation-REST |
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Inclusion Criteria:
Work-related post-traumatic stress dysfunction as measured by either of the following inclusion pathways:
(A) PTSS Pathway: PCL-5 greater than or equal to 20, OR meets criteria for full or partial PTSD on the MINI International Neuropsychiatric Interview 7 (DSM-V) (Criteria A + at least 2 B-E Criteria) OR (B) Functionally Anchored Pathway: evidence of work-related trauma exposure on the MINI International Neuropsychiatric Interview 7 (DSM-V) (Criterion A) or Life Events Checklist-5, and at least one of the following: Moral Injury and Distress Scale greater than or equal to 27, Sheehan Disability Scale greater than or equal to 5 on at least 1 of the 3 subscales, high or very high level of perceived stress (measured by PhenX Perceived Stress Scale greater than or equal to 16).
First responder or other emergency medical personnel
Ability to read, speak and understand English
Capable of providing consent
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Adrienne Taren, MD, PhD | Contact | 918-340-4116 | ataren@laureateinstitute.org | |
| Emily M Choquette, PhD | Contact | 918-240-2583 | echoquette@laureateinstitute.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Laureate Institute for Brain Research | Recruiting | Tulsa | Oklahoma | 74136 | United States |
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| ID | Term |
|---|---|
| D000077062 | Burnout, Psychological |
| D013313 | Stress Disorders, Post-Traumatic |
| D000073397 | Occupational Stress |
| ID | Term |
|---|---|
| D013315 | Stress, Psychological |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D040921 | Stress Disorders, Traumatic |
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Early stage feasibility, tolerability, and safety pilot.
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| Documentary | Behavioral | Participants will sit in a quiet room and watch a documentary. |
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Perceived stress measured using the Perceived Stress Scale after each experimental session and at follow-up time points
| Baseline through seven day post-intervention follow up |
| Moral Injury Effects of Floatation-REST | Moral injury measured using the Moral Injury and Distress Scale after each experimental session and at follow-up time points | Baseline through seven day post-intervention follow up |
| Depressive Symptomatology Effects of Floatation-REST | Depressive symptoms measured using the Quick Inventory of Depressive Symptomatology (QIDS-SR) after each experimental session and at follow-up time points | Baseline through seven day post-intervention follow up |
| D000068099 |
| Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
| D009784 | Occupational Diseases |