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FLOAT for Healthcare PTSS (PTSS FLOAT)

13 luglio 2026 aggiornato da: adrienne taren, Laureate Institute for Brain Research, Inc.

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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

15

Fase

  • Prima fase 1

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

  • Stati Uniti
    • Oklahoma
      • Tulsa, Oklahoma, Stati Uniti, 74136
        • Reclutamento
        • Laureate Institute for Brain Research
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto

Accetta volontari sani

No

Descrizione

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)

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Floatation-REST
Participants will float supine in a shallow pool for two one-hour sessions approximately seven days apart.
Comportamentale: 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.
Comparatore attivo: Documentary Condition
Participants will watch two one-hour documentaries in a relaxing environment approximately seven days apart.
Comportamentale: Documentary
Participants will sit in a quiet room and watch a documentary.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Adverse effects
Lasso di tempo: From baseline to post-intervention seven day follow-up
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
Lasso di tempo: Baseline through seven day post-intervention follow up
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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Burnout Effects of Floatation-REST
Lasso di tempo: Baseline through seven day post-intervention follow up
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
Lasso di tempo: Baseline through seven day post-intervention follow up
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
Lasso di tempo: Baseline through seven day post-intervention follow up
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
Lasso di tempo: Baseline through seven day post-intervention follow up
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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Laureate Institute for Brain Research, Inc.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

10 giugno 2026

Completamento primario (Stimato)

1 dicembre 2026

Completamento dello studio (Stimato)

1 dicembre 2026

Date di iscrizione allo studio

Primo inviato

8 luglio 2026

Primo inviato che soddisfa i criteri di controllo qualità

13 luglio 2026

Primo Inserito (Effettivo)

17 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

17 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

13 luglio 2026

Ultimo verificato

1 luglio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • #20261153

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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