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FLOAT for Healthcare PTSS (PTSS FLOAT)

2026년 7월 13일 업데이트: 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.

연구 개요

상세 설명

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.

연구 유형

중재적

등록 (추정된)

15

단계

  • 초기 1단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처 백업

연구 장소

    • Oklahoma
      • Tulsa, Oklahoma, 미국, 74136
        • 모병
        • Laureate Institute for Brain Research
        • 연락하다:

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인

건강한 자원 봉사자를 받아들입니다

아니

설명

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)

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Floatation-REST
Participants will float supine in a shallow pool for two one-hour sessions approximately seven days apart.
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.
활성 비교기: Documentary Condition
Participants will watch two one-hour documentaries in a relaxing environment approximately seven days apart.
Participants will sit in a quiet room and watch a documentary.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Adverse effects
기간: 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
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Burnout Effects of Floatation-REST
기간: 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
기간: 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
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2026년 6월 10일

기본 완료 (추정된)

2026년 12월 1일

연구 완료 (추정된)

2026년 12월 1일

연구 등록 날짜

최초 제출

2026년 7월 8일

QC 기준을 충족하는 최초 제출

2026년 7월 13일

처음 게시됨 (실제)

2026년 7월 17일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 7월 17일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 7월 13일

마지막으로 확인됨

2026년 7월 1일

추가 정보

이 연구와 관련된 용어

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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