Influence of Floatation-REST (Reduced Environmental Stimulation Therapy) on Anorexia Nervosa
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Body image dissatisfaction score on the Photographic Figure Rating Scale
研究概览
简要总结
The study proposed in this protocol aims to document the effect of Floatation-REST (reduced environmental stimulation therapy) on symptoms of anorexia nervosa.
详细描述
Flotation-REST (reduced environmental stimulation therapy) alters the balance of sensory input by systematically attenuating signals from the visual, auditory, thermal, tactile, vestibular, and proprioceptive systems. Previous research has shown that this heightens interoceptive awareness and reduces anxiety in clinically anxious populations. Anorexia nervosa (AN) is characterized by elevated anxiety, distorted body image, and disrupted interoception, raising the question of whether floatation therapy might positively impact these symptoms. A recent safety study found that Floatation-REST was well tolerated by individuals weight-restored outpatients with current or prior AN. Additionally, participants reported improvements in affective state and body image disturbance following floating, raising the possibility that this intervention might be investigated for clinical benefit in more acutely ill cases.
The primary aim of this study is to begin to examine the effect of Floatation-REST on body image disturbance in inpatients with AN. Secondary aims including determining whether Floatation-REST has an impact on anxiety, emotional distress, eating disorder severity, functional ability, and interoception.
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
- None
入排标准
- 年龄范围
- 13 Years 至 64 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Primary clinical diagnosis of anorexia nervosa
- •Receiving inpatient treatment for eating disorder
- •Body mass index greater than or equal to 16
- •No new medication prescription in the week prior to study randomization
- •Independently ambulatory
- •No current evidence of orthostatic hypotension
- •Ability to lay flat comfortably
- •Possession of a smartphone with data plan
- •English proficiency
排除标准
- •Active suicidal ideation
- •Active cutting or skin lacerating behaviors
- •Orthostatic hypotension (defined as a drop of ≥ 20 mm Hg in systolic BP or a drop of ≥ 10 mm Hg in diastolic BP when measured shortly after transitioning from lying down to standing)
- •Comorbid schizophrenia spectrum or other psychotic disorder
研究组 & 干预措施
Floatation-REST
Participants will float supine in a pool of water saturated with epsom salt, in a light and sound attenuated chamber, for up to 60 minutes, on 8 separate occasions. Ratings of the experience will be collected before and after each float.
干预措施: Floatation-REST plus usual care (Behavioral)
Usual care
Participants will be assessed along the same time periods, i.e., before and after a 60 minute window, on 8 separate occasions. Ratings of the experience will be collected before and after each time period.
干预措施: Usual care (Behavioral)
结局指标
主要结局
Body image dissatisfaction score on the Photographic Figure Rating Scale
时间窗: Through study completion, an average of 1 year
Average of the absolute change in body image dissatisfaction from pre to post float across all eight floats (score range: 0 to 10; larger changes indicate greater severity of body image dissatisfaction)
次要结局
- Functional ability on the Sheehan Disability Questionnaire(Through study completion, an average of 1 year)
- Anxiety on the Spielberger State Trait Anxiety Inventory(Through study completion, an average of 1 year)
- Interoceptive self report on the Multidimensional Interoceptive Awareness Scale(Through study completion, an average of 1 year)
- Body image disturbance on the Body Appreciation Scale-2(Through study completion, an average of 1 year)
- Eating disorder severity on the Eating Disorder Examination Questionnaire(Through study completion, an average of 1 year)
- Body image disturbance on the Body Image States Scale(Through study completion, an average of 1 year)
- Anxiety on the NIH Promis Anxiety Scale(Through study completion, an average of 1 year)
- Anxiety sensitivity on the Anxiety Sensitivity Index-3R(Through study completion, an average of 1 year)