Recruiting
Early Phase 1

Floatation-REST

Sponsor:

Laureate Institute for Brain Research, Inc.

Code:

NCT07710417

Conditions

Posttraumatic Stress Symptoms

Burnout

Burnout, Healthcare Workers

First Responders

PTSD

Eligibility Criteria

Sex: All

Age: 18 - 64

Healthy Volunteers: Not accepted

Interventions

Floatation-REST

Documentary

Study Details

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

Posttraumatic Stress Symptoms

Burnout

Burnout, Healthcare Workers

First Responders

PTSD

Study ID

NCT07710417

Start date

Jun 10, 2026

Status verified date

Jul, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 64

Healthy Volunteers: Not accepted

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 Design

Enrollment

15 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Floatation-REST

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

active comparator: Documentary Condition

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

Interventions

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.

Documentary

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

Primary outcome measure

  • Adverse effects [ Time Frame: From baseline to post-intervention seven day follow-up ]
  • Dropout Rate [ Time Frame: Baseline through seven day post-intervention follow up ]

Central Contacts and Locations

Central contacts

Locations

Laureate Institute for Brain Research

Recruiting

Tulsa, Oklahoma, United States, 74136

Contacts

More Information

Sponsor

Laureate Institute for Brain Research, Inc.

Last update posted

Jul 17, 2026

Last verified

Jul, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Laureate Institute for Brain Research, Inc. on 2026-07-17.