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Floatation-REST and Anorexia Nervosa

Primary Purpose

Anorexia Nervosa

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Floatation-REST plus usual care
Usual care
Sponsored by
Laureate Institute for Brain Research, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anorexia Nervosa focused on measuring Anorexia nervosa, Floatation therapy

Eligibility Criteria

13 Years - 64 Years (Child, Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Laureate Institute for Brain Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Floatation-REST

Usual care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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)
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)
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)
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)
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)
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)
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)
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)

Full Information

First Posted
March 19, 2018
Last Updated
October 4, 2023
Sponsor
Laureate Institute for Brain Research, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03610451
Brief Title
Floatation-REST and Anorexia Nervosa
Official Title
Influence of Floatation-REST (Reduced Environmental Stimulation Therapy) on Anorexia Nervosa
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 16, 2018 (Actual)
Primary Completion Date
March 1, 2022 (Actual)
Study Completion Date
October 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Laureate Institute for Brain Research, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anorexia Nervosa
Keywords
Anorexia nervosa, Floatation therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Pragmatic randomized controlled trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Floatation-REST
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual care
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Floatation-REST plus usual care
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Usual care
Intervention Description
Individuals will receive usual care on the inpatient unit of the Laureate Eating Disorders Program.
Primary Outcome Measure Information:
Title
Body image dissatisfaction score on the Photographic Figure Rating Scale
Description
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
Secondary Outcome Measure Information:
Title
Anxiety on the Spielberger State Trait Anxiety Inventory
Description
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
Title
Anxiety on the NIH Promis Anxiety Scale
Description
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
Title
Anxiety sensitivity on the Anxiety Sensitivity Index-3R
Description
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
Title
Eating disorder severity on the Eating Disorder Examination Questionnaire
Description
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
Title
Functional ability on the Sheehan Disability Questionnaire
Description
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
Title
Body image disturbance on the Body Image States Scale
Description
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
Title
Interoceptive self report on the Multidimensional Interoceptive Awareness Scale
Description
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
Title
Body image disturbance on the Body Appreciation Scale-2
Description
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

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sahib Khalsa, MD, PhD
Organizational Affiliation
Laureate Institute for Brain Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Laureate Institute for Brain Research
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Floatation-REST and Anorexia Nervosa

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