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

研究 Flotation-REST 作为减少焦虑和抑郁的新技术

• 批准号: 9979772
• 负责人: SAHIB KHALSA
• 金额: $ 20.87万
• 依托单位: LAUREATE INSTITUTE FOR BRAIN RESEARCH
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-09-25 至 2022-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9979772
• 关键词: Adherence; Adverse effects; Affect; Agoraphobia; Americas; Anti-Anxiety Agents; Antidepressive Agents; Anxiety; Anxiety Disorders; Arousal; Auditory; Chronic stress; Clinical; Clinical Trials; Clinical Trials Design; Consumption; Data; Diagnosis; Dose; Dropout; Environment; Equipment and supply inventories; Feeling; Frequencies; Future; Happiness; Hour; Individual; Intervention; Laboratories; Light; Long-Term Effects; Major Depressive Disorder; Measures; Mental Depression; Meta-Analysis; Mind-Body Intervention; Moods; Movement; Muscle Tension; Nervous system structure; Outcome; Pain; Panic Disorder; Participant; Patient Self-Report; Patients; Personal Satisfaction; Physiological; Pilot Projects; Placebo Effect; Population; Procedures; Protocols documentation; Randomized; Randomized Controlled Trials; Relaxation; Reporting; Research; Rest; Safety; Sampling; Sensory; Signal Transduction; Sodium Chloride; Speech; Stress; Supination; Tactile; Target Populations; Techniques; Testing; Time; Unipolar Depression; Visual; Water; adherence rate; antidepressant effect; anxiety states; anxiety symptoms; anxious; clinical anxiety; clinical effect; comorbidity; design; disability; early phase clinical trial; efficacy study; experience; follow-up; generalized anxiety; improved; interest; negative affect; novel; preference; recruit; reduce symptoms; response; smartphone Application; social anxiety; standardize measure; time use; treatment adherence; treatment response

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.

项目概要 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 人口，并且是全世界残疾的主要原因。最近的荟萃分析和大规模 临床试验表明，只有约 50% 的患者在治疗后病情有所改善，而且情况较差 共病焦虑和抑郁患者的结果和依从性。鉴于治疗效果不佳 由于对现有疗法的反应和坚持，必须探索新的帮助方法 患有焦虑症和抑郁症的患者。漂浮-REST（减少环境刺激疗法）是一种 相对未经探索的身心干预，通过系统地自然减少生理压力 通过仰卧在水池中漂浮的简单动作，减少对神经系统的感官刺激 用泻盐饱和的水。在过去的十年里，漂浮运动的受欢迎程度迅速上升， 美国各地开设了数百个休闲水上中心。尽管公众兴趣激增， 消耗量方面，很少有研究调查 Floatation-REST，特别是在临床人群中。 我们的实验室最近完成了一项针对 30 名患有焦虑和抑郁症的患者的初步研究，结果显示 一次 1 小时的漂浮训练就能够引起强烈的抗焦虑和抗抑郁反应 伴随着情绪和主观幸福感的显着改善。而且，效果并不 效果是短暂的，因为受试者表示在接下来的 24 小时内感觉持续受益。该提案旨在 通过调查这些有希望的发现的可行性、耐受性和安全性来跟进 对 75 名患有临床焦虑症的参与者进行多次漂浮休息或主动比较条件 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具有可比性，并且辍学率较低（<20%） 副作用最小，为接受多次治疗的可行性、耐受性和安全性提供初步证据 Floatation-REST 会话和该目标人群中的主动比较条件。探索性目标 检查漂浮休息的抗焦虑和抗抑郁作用的程度和持续时间 短期（最多 48 小时）和长期（最多 6 周）间隔，为是否 任何有益的效果都会在漂浮体验之外持续存在。这项早期临床试验的结果将 帮助优化未来功效研究的设计，探索长期抗焦虑和抗抑郁作用 浮动休息。