FLOAT for Healthcare PTSS

NCT07710417 | Recruiting Early Phase 1

• 1 other identifier: #20261153
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Post-traumatic Stress Symptoms; Burnout; Burnout, Healthcare Workers; First Responders; PTSD; Healthcare Workforce Well-Being

Keywords

Floatation-REST; Posttraumatic Stress Symptoms; PTSD; First Responders; Burnout; Healthcare Workers; Emergency Medical Personnel; Occupational Stress; Post-traumatic Stress Symptoms

Outcome Measures

Primary Outcomes (2)

• 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  As a proxy for tolerability, dropout rate for each arm = (# of subjects who are withdrawn from the study)/(# participants in specific arm).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 Outcomes (4)

• Burnout Effects of Floatation-REST

  Baseline through seven day post-intervention follow up

• Perceived Stress Effects of Floatation-REST

  Baseline through seven day post-intervention follow up

• Moral Injury Effects of Floatation-REST

  Baseline through seven day post-intervention follow up

• Depressive Symptomatology Effects of Floatation-REST

  Baseline through seven day post-intervention follow up

Study Arms (2)

Floatation-REST

EXPERIMENTAL

Participants will float supine in a shallow pool for two one-hour sessions approximately seven days apart.

Behavioral: Floatation-REST

Documentary Condition

ACTIVE COMPARATOR

Participants will watch two one-hour documentaries in a relaxing environment approximately seven days apart.

Behavioral: Documentary

Interventions

Documentary BEHAVIORAL

Participants will sit in a quiet room and watch a documentary.

Documentary Condition

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.

Floatation-REST

Eligibility Criteria

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

You may qualify if:

• (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

You may not qualify if:

• History of neurological conditions
• Skin conditions or open wounds
• DSM-5 diagnosis of psychotic spectrum disorders, obsessive-compulsive disorder, bipolar disorder, severe substance use disorder, or eating disorder
• Inability to lay comfortably in a shallow pool of water
• Failure to adhere to "pre-float checklist"
• Breathalyzer test positive for alcohol or a drug-positive urine test
• Unwillingness to provide consent or complete major aspects of protocol
• MRI contraindications
• Unstable medical diagnoses
• Pregnancy
• Evidence of inability to comply with study procedures based on experimenter judgement
• 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)

Sponsors & Collaborators

• Laureate Institute for Brain Research, Inc.: lead

Study Sites (1)

Laureate Institute for Brain Research

Tulsa, Oklahoma, 74136, United States

RECRUITING

MeSH Terms

Conditions

Burnout, Psychological; Stress Disorders, Post-Traumatic; Occupational Stress

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Occupational Diseases

Central Study Contacts

Adrienne Taren, MD, PhD

CONTACT

918-340-4116; ataren@laureateinstitute.org

Emily M Choquette, PhD

CONTACT

918-240-2583; echoquette@laureateinstitute.org

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Investigator

Model Details: Early stage feasibility, tolerability, and safety pilot.

Study Record Dates

• First Submitted: July 8, 2026
• First Posted: July 17, 2026
• Study Start: June 10, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 17, 2026

Record last verified: 2026-07

Locations

US (1)