FLOAT for Healthcare PTSS (PTSS FLOAT)
Neural Mechanisms of Floatation-REST Therapy for Post-Traumatic Stress Symptoms in Frontline Healthcare Workers
研究概览
地位
详细说明
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.
研究类型
注册 (估计的)
阶段
- 第一阶段早期
联系人和位置
学习联系方式
- 姓名:Adrienne Taren, MD, PhD
- 电话号码:918-340-4116
- 邮箱:ataren@laureateinstitute.org
研究联系人备份
- 姓名:Emily M Choquette, PhD
- 电话号码:918-240-2583
- 邮箱:echoquette@laureateinstitute.org
学习地点
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Oklahoma
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Tulsa、Oklahoma、美国、74136
- 招聘中
- Laureate Institute for Brain Research
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接触:
- LIBR Assessment Team
- 电话号码:918-502-5100
- 邮箱:info@laureateinstitute.org
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参与标准
资格标准
适合学习的年龄
- 成人
接受健康志愿者
描述
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)
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的: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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有源比较器: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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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Adverse effects
大体时间: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
大体时间: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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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Burnout Effects of Floatation-REST
大体时间: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
大体时间: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
大体时间: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
大体时间: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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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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