Floatation-REST for frontline workers with post-traumatic stress symptoms

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-site, randomized pilot study in adults aged 18-64 with work-related PTSS to test the feasibility, tolerability, and safety of Floatation-REST versus a documentary-viewing control. Participants will receive two 60-minute float sessions or documentary viewing, with the aim of seeing if this low-burden intervention can be implemented in high-demand healthcare settings. The study uses a 2:1 randomization to Floatation-REST versus documentary and plans up to 30 participants with 15 completers. Outcomes focus on feasibility and safety, with secondary signals related to PTSS symptoms. The approach builds on prior work suggesting acute stress reduction with Floatation-REST, pending evaluation in this population.

Why it matters

Who can join: the full rules

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)

Where it's running

• Laureate Institute for Brain Research
  Tulsa, Oklahoma, United States Recruiting

Study contacts

• Study coordinator: Adrienne Taren, MD, PhD
• Email: ataren@laureateinstitute.org
• Phone: 918-340-4116

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.