FLOAT for Healthcare PTSS (PTSS FLOAT)
Neural Mechanisms of Floatation-REST Therapy for Post-Traumatic Stress Symptoms in Frontline Healthcare Workers
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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 de estudio
Inscripción (Estimado)
Fase
- Fase temprana 1
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Adrienne Taren, MD, PhD
- Número de teléfono: 918-340-4116
- Correo electrónico: ataren@laureateinstitute.org
Copia de seguridad de contactos de estudio
- Nombre: Emily M Choquette, PhD
- Número de teléfono: 918-240-2583
- Correo electrónico: echoquette@laureateinstitute.org
Ubicaciones de estudio
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Oklahoma
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Tulsa, Oklahoma, Estados Unidos, 74136
- Reclutamiento
- Laureate Institute for Brain Research
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Contacto:
- LIBR Assessment Team
- Número de teléfono: 918-502-5100
- Correo electrónico: info@laureateinstitute.org
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
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).
- First responder or other emergency medical personnel
- Ability to read, speak and understand English
- Capable of providing consent
Exclusion Criteria:
- 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)
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Floatation-REST
Participants will float supine in a shallow pool for two one-hour sessions approximately seven days apart.
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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.
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Comparador activo: Documentary Condition
Participants will watch two one-hour documentaries in a relaxing environment approximately seven days apart.
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Participants will sit in a quiet room and watch a documentary.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Adverse effects
Periodo de tiempo: From baseline to post-intervention seven day follow-up
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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.
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From baseline to post-intervention seven day follow-up
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Dropout Rate
Periodo de tiempo: Baseline through seven day post-intervention follow up
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As a proxy for tolerability, dropout rate for each arm = (# of subjects who are withdrawn from the study)/(# participants in specific arm).
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Baseline through seven day post-intervention follow up
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Burnout Effects of Floatation-REST
Periodo de tiempo: Baseline through seven day post-intervention follow up
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Burnout measured using the MBI-HSS questionnaire after each experimental session and at follow-up time points
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Baseline through seven day post-intervention follow up
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Perceived Stress Effects of Floatation-REST
Periodo de tiempo: Baseline through seven day post-intervention follow up
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Perceived stress measured using the Perceived Stress Scale after each experimental session and at follow-up time points
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Baseline through seven day post-intervention follow up
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Moral Injury Effects of Floatation-REST
Periodo de tiempo: Baseline through seven day post-intervention follow up
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Moral injury measured using the Moral Injury and Distress Scale after each experimental session and at follow-up time points
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Baseline through seven day post-intervention follow up
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Depressive Symptomatology Effects of Floatation-REST
Periodo de tiempo: Baseline through seven day post-intervention follow up
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Depressive symptoms measured using the Quick Inventory of Depressive Symptomatology (QIDS-SR) after each experimental session and at follow-up time points
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Baseline through seven day post-intervention follow up
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- #20261153
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
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