Laureate Institute for Brain Research
Tulsa, Oklahoma, 74136, United States
NCT Number: NCT02801084
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.
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Notify Me18 year–80 year
All sexes
Interventional
Not applicable
Tulsa, Oklahoma, 74136, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will complete one arm involving four sequential float sessions. Float 1: chair float. Participants will first float in a comfortable chair in the supine position, for up to 90 minutes. The chair is in a room with sound and light attenuation. Orthostatic blood pressure (BP) will be measured before and after each float. Anxiety and body image will be measured afterwards.
Float 2: open pool float. Participants will float for up to 90 minutes in an open pool (8 foot diameter, no enclosure). Orthostatic BP will be measured before and after each float. Anxiety and body image will be measured afterwards.
Floats 3 & 4: domed pool float. Participants will float for up to 90 minutes in a domed pool the same size as the open pool, with an enclosure wall and 8 foot tall ceiling. Orthostatic BP will be measured before and after each float. Anxiety and body image will be measured afterwards.
Each float will occur approximately 1 to 7 days apart.
Other names: Floating
Time frame: 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.
Time frame: Immediately before and after each float session for 4 float sessions, spaced weekly to monthly for up to 16 weeks study duration
Measured via self-report measure (Positive and Negative Affect Schedule X)
Time frame: Immediately before and after each float session for 4 float sessions, spaced weekly to monthly for up to 16 weeks study duration
Interoceptive and exteroceptive sensations, measured via visual analogue scale (e.g., 0 to 100)
Time frame: Obtained at baseline and immediately after each float session for 4 float sessions, spaced weekly to monthly for up to 16 weeks study duration
Measured via Photographic Figure Rating Scale, Body Appreciation Scale, Body Image States Scale, Body Shape Questionnaire, visual analogue scale (e.g., 0 to 10).
Time frame: During the first, second, and fourth float for 4 float sessions, spaced weekly to monthly for up to 16 weeks study duration
May be measured during the first, second, and fourth float.
Time frame: 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
Measured during the first, second, and fourth float.
Time frame: Obtained during the first visit
Measured via the Eating Disorder Examination Questionnaire
Time frame: Obtained during the first visit
Measured via the Childhood Trauma Questionnaire
Time frame: 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
Measured via self-report measure (Spielberger State-Trait Anxiety Index)
Time frame: Obtained during the first visit
Measured via the Anxiety Sensitivity Index
Laureate Institute for Brain Research, Inc.
Other
Examining the Effects of Reduced Environmental Stimulation on Eating Disorders
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