Floatation-REST and Anorexia Nervosa

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Anorexia Nervosa
• Intervention / Treatment: Behavioral: Floatation-REST plus usual care; Behavioral: Usual care

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 68
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74136
      • Laureate Institute for Brain Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 64 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
Other: 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 usual care on the inpatient unit of the Laureate Eating Disorders Program.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Laureate Institute for Brain Research, Inc.
• Investigators: Principal Investigator: Sahib Khalsa, MD, PhD, Laureate Institute for Brain Research

Study record dates

Study Major Dates

• Study Start (Actual): March 16, 2018
• Primary Completion (Actual): March 1, 2022
• Study Completion (Estimated): October 1, 2024

Study Registration Dates

• First Submitted: March 19, 2018
• First Submitted That Met QC Criteria: July 25, 2018
• First Posted (Actual): August 1, 2018

Study Record Updates

• Last Update Posted (Actual): October 5, 2023
• Last Update Submitted That Met QC Criteria: October 4, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Anorexia nervosa; Floatation therapy
• Additional Relevant MeSH Terms: Mental Disorders; Signs and Symptoms, Digestive; Feeding and Eating Disorders; Anorexia; Anorexia Nervosa
• Other Study ID Numbers: 2018-001-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No