Examining the Effects of Reduced Environmental Stimulation on Eating Disorders
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Orthostatic blood pressure
研究概览
简要总结
The study proposed in this protocol aims to document the physiological, subjective, behavioral, and neural effects of reduced environmental stimulation (floating) in patients with current or prior anorexia nervosa The primary aim of this study is to determine the safety of this intervention. Secondary aims including determining whether floating has an impact on symptom reports such as those related to anxiety and eating disorders.
详细描述
Floating creates an environment with minimal visual, auditory, tactile, proprioceptive, and thermal input to the brain. The float rooms used in this study are both lightproof, and thus completely dark when the entry door is sealed and the lights are turned off, reducing all visual input to the brain. Each float room was constructed with thick soundproof walls, restricting most outside noises from entering the room, thereby reducing auditory input to the brain. A high concentration Epsom salt water solution allows individuals to effortlessly float on their back while remaining completely still, reducing both proprioceptive and tactile input to the brain. The temperature of the water is calibrated to the temperature of the skin (~94° F) and the temperature of the air is calibrated to the temperature of the water, making it difficult to discern the boundary between air and water, thus reducing thermal input to the brain while minimizing the need for thermoregulation of the skin.
While both float pools dramatically reduce external sensory information, it is important to note that participants are in full control over the experience. For example, participants can enter and exit the float pool whenever they choose. Each float pool also contains a blue LED light that can be turned on and off via an air-coupled light switch in the pool. Both float rooms contain a shower for cleaning before and after floating.
In a prior study the investigators have found that healthy participants found the pool condition to be relaxing and stress relieving. The current study aims to determine the safety of floating with a clinical population, specifically individuals with a history of eating disorder who are of normal weight.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Current or prior diagnosis of anorexia nervosa (AN)
- •All AN participants must be weight-restored prior to their participation, defined as having a Body Mass Index (BMI) > 17.5
排除标准
- •Any of the following DSM-V disorders:
- •Schizophrenia Spectrum and Other Psychotic Disorders
- •Bipolar and Related Disorders
- •Currently being treated for their psychiatric condition as an inpatient.
- •Active suicidal ideation with intent or plan (as determined by a psychiatrist or clinical psychologist for all participants who report an IDAS-II suicide score > 10).
- •Morbid obesity (BMI > 40) or underweight (BMI < 17.5).
- •Orthostatic hypotension (defined as a drop of ≥20 mm Hg in systolic blood pressure or a drop of ≥10 mm Hg in diastolic blood pressure when measured shortly after transitioning from lying down to standing).
- •Certain drugs or medications consumed within the past week including any psychoactive drugs (e.g., MDMA, LSD, psilocybin, peyote, phencyclidine, ketamine), magnesium supplements (greater than 150mg) or milk of magnesia. Any antihistamine that causes drowsiness (e.g., Benadryl) or any alcohol consumed within the past 12 hours. Caffeine or nicotine consumed within the past 3 hours. For all other medications, participants must be stably medicated prior to participation (defined as having taken the medication for 6 weeks or longer).
- •History of unstable liver or renal insufficiency; glaucoma; diabetes; significant and unstable cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, or metabolic disturbance.
- •Pregnancy as detected by a urine test.
- •Failure to adhere to "Pre-float checklist".
- •Non-correctable vision or hearing problems.
结局指标
主要结局
Orthostatic blood pressure
时间窗: Immediately before and after each float session for 4 float sessions, spaced weekly to monthly for up to 16 weeks study duration
Defined as a drop of ≥20 mm Hg in systolic blood pressure or a drop of ≥10 mm Hg in diastolic blood pressure when measured shortly after transitioning from lying down to standing.
次要结局
- Body image(Obtained at baseline and immediately after each float session for 4 float sessions, spaced weekly to monthly for up to 16 weeks study duration)
- EEG changes during the float experience(During the first, second, and fourth float for 4 float sessions, spaced weekly to monthly for up to 16 weeks study duration)
- Eating disorder severity(Obtained during the first visit)
- Self-ratings of changes in anxiety(Obtained at baseline and immediately before and after each float session for 4 float sessions, spaced weekly to monthly for up to 16 weeks study duration)
- Trauma exposure(Obtained during the first visit)
- Self-ratings of anxiety sensitivity(Obtained during the first visit)
- Self-ratings of changes in emotional experience(Immediately before and after each float session for 4 float sessions, spaced weekly to monthly for up to 16 weeks study duration)
- Self-ratings of changes in physical experience(Immediately before and after each float session for 4 float sessions, spaced weekly to monthly for up to 16 weeks study duration)
- Heart rate variability during the float experience(Obtained at baseline and after the first, second, and fourth float for 4 float sessions, spaced weekly to monthly for up to 16 weeks study duration)