Floatation-REST and Anorexia Nervosa

Anorexia Nervosa Clinical Trial

Official title:

Influence of Floatation-REST (Reduced Environmental Stimulation Therapy) on Anorexia Nervosa

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03610451
• Other study ID #: 2018-001-02
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 16, 2018
• Est. completion date: October 2024

Study information

• Verified date: October 2023
• Source: Laureate Institute for Brain Research, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study proposed in this protocol aims to document the effect of Floatation-REST (reduced environmental stimulation therapy) on symptoms of anorexia nervosa.

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 68
• Est. completion date: October 2024
• Est. primary completion date: March 1, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 13 Years to 64 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Anorexia
• Anorexia Nervosa

Intervention

Behavioral:
• Floatation-REST plus 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.
• Usual care
Individuals will receive usual care on the inpatient unit of the Laureate Eating Disorders Program.

Locations

Country	Name	City	State
United States	Laureate Institute for Brain Research	Tulsa	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
Laureate Institute for Brain Research, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Through study completion, an average of 1 year
Secondary	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)	Through study completion, an average of 1 year
Secondary	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)	Through study completion, an average of 1 year
Secondary	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)	Through study completion, an average of 1 year
Secondary	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)	Through study completion, an average of 1 year
Secondary	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)	Through study completion, an average of 1 year
Secondary	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)	Through study completion, an average of 1 year
Secondary	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)	Through study completion, an average of 1 year
Secondary	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)	Through study completion, an average of 1 year