Investigating Floatation-REST as a Novel Technique for Reducing Anxiety and Depression
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Adherence
研究概览
简要总结
This early-stage trial aims to examine the feasibility, tolerability, and safety of Floatation-REST (Reduced Environmental Stimulation Therapy) or an active comparison condition in 75 participants with clinical anxiety and depression.
详细描述
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. More than three-quarters of patients never receive treatment, and recent meta-analyses and large-scale clinical trials suggest that only about half of patients improve with treatment, with substantially poorer outcomes and adherence in patients with comorbid anxiety and depression. Given the insufficient treatment response and adherence to currently available therapies, it is important to explore novel 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 attenuating exteroceptive sensory input to the nervous system through the act of floating supine in a pool of water saturated with Epsom salt (magnesium sulfate). Over the past decade, floating has witnessed a rapid rise in popularity, with hundreds of recreational float centers opening across America. Despite the surge in public interest and consumption, there has been little research investigation Floatation-REST, especially in clinical populations. The investigators recently completed several pilot studies in patients with comorbid anxiety and depression showing that a single float session was capable of inducing a large short-term anxiolytic and antidepressant response accompanied by a substantial improvement in mood and subjective well-being. This proposal aims to follow-up on these promising preliminary 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. Since this study is aimed at examining feasibility, tolerability, and safety, the primary endpoint is adherence (as a proxy of feasibility), and the secondary outcome measures are dropout rate (as a proxy for tolerability) and adverse effects (as a proxy for safety). 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 months) intervals, providing an initial indication for whether any beneficial effects are sustained beyond the float experience. The results of this early phase clinical trials will help optimize the design of a future efficacy study exploring the long-term effects of Floatation-REST.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
The investigator and participant are masked to study arm until after the participant completes their baseline session, at which point they are randomized using a sealed envelope.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •High level of acute anxiety (OASIS score ≥ 6)
- •High anxiety sensitivity (ASI-3 total score ≥ 24)
- •If taking medication or receiving psychotherapy, must be stably undergoing treatment prior to participation (defined as having taken the medication or been in therapy for 8 weeks or longer). If taking a benzodiazepine or opioid, must be willing to abstain within 24 hours of a float session (daily users will be excluded from the study).
- •No prior Floatation-REST experience or a minimum of 1 year since previous float session
- •Seeking treatment for their anxiety/depression and willing to complete the study
排除标准
- •History of Bipolar Disorder, Schizophrenia spectrum or other psychotic disorders
- •Current Eating Disorder (anorexia/bulimia nervosa)
- •Current Substance Use Disorder ≥ moderate. Tobacco and Caffeine Use is allowed. Must be willing to abstain from all other substances within 24 hours of a float session.
- •Active suicidality with plan/intent
- •History of a neurological condition (e.g., epilepsy) or any other medical condition that could interfere with the protocol
- •Any skin conditions or open wounds that could cause pain when exposed to saltwater
- •Uncomfortable being in water
- •Positive pregnancy test
- •Acutely intoxicated day of floating (determined via positive urine drug screen or breathalyzer)
研究组 & 干预措施
Float Pool
Floating supine in a pool for a prescribed amount of time (6 total sessions, 1 hour/session, 1 session/week)
干预措施: Float pool (Behavioral)
Float Chair
Floating supine in a zero-gravity chair for a prescribed amount of time (6 total sessions, 1 hour/session, 1 session/week)
干预措施: Float chair (Behavioral)
Float Pool Preferred
Floating supine in a pool for a preferred amount of time (6 total sessions, up to 2 hours/session, as frequently as they prefer within a 12-week period with a minimum of 24 hours between sessions)
干预措施: Float pool (Behavioral)
结局指标
主要结局
Adherence
时间窗: Over 6-9 week period of intervention (up to 12 weeks for preferred pool arm)
As a proxy of feasibility, adherence for each subject = (# of sessions completed)/6. All subjects (in all arms of the study) are given up to 3 opportunities to reschedule missed appointments, after which they are withdrawn from the study.
次要结局
- Dropout rate(Over 6-9 week period of intervention (up to 12 weeks for preferred pool arm))
- Adverse effects(Over 6-9 week period of intervention (up to 12 weeks for preferred pool arm))
- Muscle Tension rating on the Visual Analog Scale (VAS)(Through completion of the final float session)
- Heartbeat perception rating(Through completion of the final float session)
- Anxiety on the Brief Symptom Inventory-18(Through study completion, an average of 6 months after the final float session)
- Depression on the Brief Symptom Inventory-18(Through study completion, an average of 6 months after the final float session)
- Positive Affect on the Positive and Negative Affect Schedule-X (PANAS-X)(Through completion of the final float session)
- Serenity on the Positive and Negative Affect Schedule-X (PANAS-X)(Through completion of the final float session)
- State Anxiety on the State Trait Anxiety Inventory (STAI)(Through completion of the final float session)
- Pain on the Wong-Baker Pain Scale (WBPS)(Through completion of the final float session)
- Trait Anxiety on the State Trait Anxiety Inventory(Through study completion, an average of 6 months after the final float session)
- Somatization on the Brief Symptom Inventory-18(Through study completion, an average of 6 months after the final float session)
- Anxiety on the clinician-rated Hamilton Anxiety Rating Scale (HAM-A)(Through study completion, an average of 6 months after the final float session)
- Disability on the Sheehan Disability Scale(Through study completion, an average of 6 months after the final float session)
- Negative Affect on the Positive and Negative Affect Schedule-X (PANAS-X)(Through completion of the final float session)
- Psychological Distress on the Brief Symptom Inventory-18(Through study completion, an average of 6 months after the final float session)
- Anxiety remission(An average of 6 weeks after the final float session)
- Depression on the Patient Health Questionnaire-9 (PHQ-9)(Through study completion, an average of 6 months after the final float session)
- Depression on the clinician-rated Montgomery Åsberg Rating Scale (MADRS)(Through study completion, an average of 6 months after the final float session)
- Anxiety responder(Through study completion, an average of 6 months after the final float session)
- Depression remission(An average of 6 weeks after the final float session)
- Depression responder(Through study completion, an average of 6 months after the final float session)
- Anxiety on the Overall Anxiety Severity and Impairment Scale (OASIS)(Through study completion, an average of 6 months after the final float session)
- Anxiety Sensitivity on the Anxiety Sensitivity Index-3R (ASI-3R)(Through study completion, an average of 6 months after the final float session)
- Cardiac interoceptive accuracy(Through completion of the final float session)