FLOAT for Healthcare PTSS (PTSS FLOAT)

Neural Mechanisms of Floatation-REST Therapy for Post-Traumatic Stress Symptoms in Frontline Healthcare Workers

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.

Study Overview

• Status: Recruiting
• Conditions: PTSD; Burnout; Posttraumatic Stress Symptoms; Post-traumatic Stress Symptoms; First Responders; Burnout, Healthcare Workers; Healthcare Workforce Well-Being
• Intervention / Treatment: Behavioral: Floatation-REST; Behavioral: Documentary

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Adrienne Taren, MD, PhD; Phone Number: 918-340-4116; Email: ataren@laureateinstitute.org
• Study Contact Backup: Name: Emily M Choquette, PhD; Phone Number: 918-240-2583; Email: echoquette@laureateinstitute.org

Study Locations

• United States
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74136
      • Recruiting
      • Laureate Institute for Brain Research
      • Contact: LIBR Assessment Team; Phone Number: 918-502-5100; Email: info@laureateinstitute.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 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).

2. First responder or other emergency medical personnel
3. Ability to read, speak and understand English
4. Capable of providing consent

Exclusion Criteria:

1. History of neurological conditions
2. Skin conditions or open wounds
3. DSM-5 diagnosis of psychotic spectrum disorders, obsessive-compulsive disorder, bipolar disorder, severe substance use disorder, or eating disorder
4. Inability to lay comfortably in a shallow pool of water
5. Failure to adhere to "pre-float checklist"
6. Breathalyzer test positive for alcohol or a drug-positive urine test
7. Unwillingness to provide consent or complete major aspects of protocol
8. MRI contraindications
9. Unstable medical diagnoses
10. Pregnancy
11. Evidence of inability to comply with study procedures based on experimenter judgement
12. Change in the dose or prescription of a medication within the 6 weeks before enrolling in the study that could affect brain functioning (e.g., anxiolytics, antipsychotics, antidepressants, benzodiazepines, or mood stabilizers)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Floatation-REST; Participants will float supine in a shallow pool for two one-hour sessions approximately seven days apart.	Behavioral: Floatation-REST; 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.
Active Comparator: Documentary Condition; Participants will watch two one-hour documentaries in a relaxing environment approximately seven days apart.	Behavioral: Documentary; Participants will sit in a quiet room and watch a documentary.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Laureate Institute for Brain Research, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: July 8, 2026
• First Submitted That Met QC Criteria: July 13, 2026
• First Posted (Actual): July 17, 2026

Study Record Updates

• Last Update Posted (Actual): July 17, 2026
• Last Update Submitted That Met QC Criteria: July 13, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: PTSD; Occupational Stress; Posttraumatic Stress Symptoms; Burnout; Healthcare Workers; Floatation-REST; First Responders; Post-traumatic Stress Symptoms; Emergency Medical Personnel
• Additional Relevant MeSH Terms: Trauma and Stressor Related Disorders; Mental Disorders; Behavioral Symptoms; Stress, Psychological; Occupational Diseases; Stress Disorders, Traumatic; Behavior; Burnout, Psychological; Occupational Stress; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: #20261153

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No