An interventional study of Floatation-REST plus usual care and Usual care in Anorexia Nervosa, sponsored by Laureate Institute for Brain Research, Inc.. Active, not recruiting at 1 site in United States. Open to female participants aged 13 Years to 64 Years. Per ClinicalTrials.gov, last updated 2023-10-05.
Sponsored by Laureate Institute for Brain Research, Inc. · Not applicable, Interventional, and Treatment
The study proposed in this protocol aims to document the effect of Floatation-REST (reduced environmental stimulation therapy) on symptoms of anorexia nervosa.
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.
411 studies on the registry are indexed under Anorexia; 67 are open to participants now.
This study's enrollment of 68 is above the median of 41 across 287 interventional studies indexed under Anorexia.
Browse Anorexia studies →Laureate Institute for Brain Research, Inc. is the lead sponsor of 53 studies on the registry; 12 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Behavioral: Floatation-REST plus 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.
Behavioral: Usual care
Individuals will receive Floatation-REST plus usual care. Floating creates an environment with minimal visual, auditory, tactile, proprioceptive, and thermal input to the brain. The float rooms are lightproof and soundproof. 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.
Individuals will receive usual care on the inpatient unit of the Laureate Eating Disorders Program.
Body image dissatisfaction score on the Photographic Figure Rating Scale
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)
Time frame: Through study completion, an average of 1 year
Anxiety on the Spielberger State Trait Anxiety Inventory
Average of the change in anxiety rating from pre to post float across all eight float (range 20 to 80, higher scores indicate greater severity of anxiety)
Time frame: Through study completion, an average of 1 year
Anxiety on the NIH Promis Anxiety Scale
Average of the change in anxiety rating from pre to post float across all eight float (range 6 to 30, higher scores indicate greater severity of anxiety)
Time frame: Through study completion, an average of 1 year
Anxiety sensitivity on the Anxiety Sensitivity Index-3R
Change in anxiety sensitivity after the final float relative to baseline (range 0 to 96, higher scores indicate greater severity of anxiety sensitivity)
Time frame: Through study completion, an average of 1 year
Eating disorder severity on the Eating Disorder Examination Questionnaire
Change in eating disorder severity after the final float relative to baseline (range 0 to 6, larger scores indicate greater severity of eating disorder)
Time frame: Through study completion, an average of 1 year
Functional ability on the Sheehan Disability Questionnaire
Change in functional ability after the final float relative to baseline (range 0 to 30, higher scores indicate greater severity of disability)
Time frame: Through study completion, an average of 1 year
Body image disturbance on the Body Image States Scale
Change in body image disturbance after the final float relative to baseline (range 0 to 48, higher scores indicate greater severity of body image disturbance)
Time frame: Through study completion, an average of 1 year
Interoceptive self report on the Multidimensional Interoceptive Awareness Scale
Change in total interoceptive awareness score after the final float relative to baseline (range 0 to 160, higher scores indicating greater interoceptive awareness)
Time frame: Through study completion, an average of 1 year
Body image disturbance on the Body Appreciation Scale-2
Change in body image disturbance score after the final float relative to baseline (range 10 to 50, higher scores indicating reduced severity of body image disturbance)
Time frame: Through study completion, an average of 1 year
Plan to share: No
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This study is active, not recruiting, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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Laureate Institute for Brain Research, Inc.