Investigating Flotation-REST as a novel technique for reducing anxiety and depression

项目摘要 焦虑和抑郁是两种最常见的精神疾病，影响了超过四分之一的人。 这是世界人口中最严重的问题，也是全世界残疾的主要原因。最近的荟萃分析和大规模的 临床试验表明，只有大约50%的患者在治疗后有所改善， 共病焦虑和抑郁患者的结局和依从性。鉴于恶劣的待遇 反应和坚持目前可用的疗法，必须探索新的方法来帮助 焦虑和抑郁的患者。浮动休息（减少环境刺激疗法）是一种 相对未开发的身心干预，通过系统地减少生理压力， 通过简单的仰卧在水池中漂浮的动作来减少神经系统的感觉刺激， 被埃普森浸透的水。在过去的十年里，浮动见证了受欢迎程度的迅速上升， 数百个娱乐花车中心在美国各地开业。尽管公众的兴趣激增， 然而，尽管有大量的消费，但很少有研究调查漂浮-REST，特别是在临床人群中。 我们的实验室最近完成了一项对30名焦虑和抑郁共病患者的初步研究， 一次1小时的漂浮训练能够诱导大量的抗焦虑和抗抑郁反应 伴随着情绪和主观幸福感的实质性改善。此外，这些影响并不 短暂的，因为受试者报告在接下来的24小时内感觉持续受益。这项建议旨在 通过研究接受化疗的可行性、耐受性和安全性， 在75名患有临床焦虑的参与者中进行多次漂浮-REST或主动比较条件 和抑郁症这些参与者中的一部分将有机会选择他们在以下方面的偏好： 浮动持续时间和频率，为未来试验中优化“剂量”提供重要信息。我们 预测所有条件下的依从率都相当，辍学率低（<20%）， 最小的不良反应，为接受多种治疗的可行性、耐受性和安全性提供初步证据。 浮动-REST会话和该目标人群中的活动比较条件。探索性的目标 检查浮动休息的抗焦虑和抗抑郁作用的幅度和持续时间， 短期（最多48小时）和长期（最多6周）间隔，提供是否 任何有益的效果都能持续到漂浮体验之后。这项早期临床试验的结果将 有助于优化未来疗效研究的设计，探索长期抗焦虑和抗抑郁作用 浮动休息。

PROJECT SUMMARY Anxiety and depression are the two most common psychiatric conditions, affecting over a quarter of the population, and representing the leading cause of disability, worldwide. Recent meta-analyses and large-scale clinical trials suggest that only about 50% of patients improve with treatment, with substantially poorer outcomes and adherence in patients with comorbid anxiety and depression. Given the poor treatment response and adherence to currently available therapies, it is imperative to explore new ways of helping patients with anxiety and depression. Floatation-REST (Reduced Environmental Stimulation Therapy) is a relatively unexplored mind-body intervention for naturally reducing physiological stress by systematically decreasing sensory stimulation of the nervous system through the simple act of floating supine in a pool of water saturated with Epsom salt. Over the past decade floating has witnessed a rapid rise in popularity, with hundreds of recreational float centers opening across America. Despite this surge in public interest and consumption, there has been little research investigating Floatation-REST, especially in clinical populations. Our laboratory recently completed a pilot study in 30 patients with comorbid anxiety and depression showing that a single 1-hour float session was capable of inducing a large anxiolytic and antidepressant response accompanied by a substantial improvement in mood and subjective well-being. Moreover, the effects were not transient, as the subjects reported feeling sustained benefit over the next 24 hours. This proposal aims to follow-up on these promising findings by investigating the feasibility, tolerability, and safety of undergoing multiple sessions of Floatation-REST or an active comparison condition in 75 participants with clinical anxiety and depression. A subset of these participants will have the opportunity to select their preference with regard to float duration and frequency, providing important information for optimizing the “dose” in future trials. We predict that adherence rates will be comparable across all conditions, with low dropout rates (<20%) and minimal adverse effects, providing initial evidence for feasibility, tolerability, and safety of undergoing multiple sessions of Floatation-REST and the active comparison condition in this target population. An exploratory aim examines the magnitude and duration of the anxiolytic and antidepressant effects of Floatation-REST at both short-term (up to 48 hours) and long-term (up to 6 weeks) intervals, providing an initial indication for whether any beneficial effects are sustained beyond the float experience. The results of this early phase clinical trial will help optimize the design of a future efficacy study exploring the long-term anxiolytic and antidepressant effects of Floatation-REST.