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Floatation-REST and Anorexia Nervosa

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03610451
Recruitment Status : Recruiting
First Posted : August 1, 2018
Last Update Posted : August 20, 2019
Sponsor:
Information provided by (Responsible Party):
Laureate Institute for Brain Research, Inc.

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.

Condition or disease Intervention/treatment Phase
Anorexia Nervosa Behavioral: Floatation-REST plus usual care Behavioral: Usual care Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Pragmatic randomized controlled trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Influence of Floatation-REST (Reduced Environmental Stimulation Therapy) on Anorexia Nervosa
Actual Study Start Date : March 16, 2018
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : March 2023

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.

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.




Primary Outcome Measures :
  1. Body image dissatisfaction score on the Photographic Figure Rating Scale [ Time Frame: Through study completion, an average of 1 year ]
    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 :
  1. Anxiety on the Spielberger State Trait Anxiety Inventory [ Time Frame: Through study completion, an average of 1 year ]
    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)

  2. Anxiety on the NIH Promis Anxiety Scale [ Time Frame: Through study completion, an average of 1 year ]
    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)

  3. Anxiety sensitivity on the Anxiety Sensitivity Index-3R [ Time Frame: Through study completion, an average of 1 year ]
    Change in anxiety sensitivity after the final float relative to baseline (range 0 to 96, higher scores indicate greater severity of anxiety sensitivity)

  4. Eating disorder severity on the Eating Disorder Examination Questionnaire [ Time Frame: Through study completion, an average of 1 year ]
    Change in eating disorder severity after the final float relative to baseline (range 0 to 6, larger scores indicate greater severity of eating disorder)

  5. Functional ability on the Sheehan Disability Questionnaire [ Time Frame: Through study completion, an average of 1 year ]
    Change in functional ability after the final float relative to baseline (range 0 to 30, higher scores indicate greater severity of disability)

  6. Body image disturbance on the Body Image States Scale [ Time Frame: Through study completion, an average of 1 year ]
    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)

  7. Interoceptive self report on the Multidimensional Interoceptive Awareness Scale [ Time Frame: Through study completion, an average of 1 year ]
    Change in total interoceptive awareness score after the final float relative to baseline (range 0 to 160, higher scores indicating greater interoceptive awareness)

  8. Body image disturbance on the Body Appreciation Scale-2 [ Time Frame: Through study completion, an average of 1 year ]
    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)



Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 64 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03610451


Contacts
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Contact: Valerie Upshaw, RN 9185025176 vupshaw@laureateinstitute.org

Locations
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United States, Oklahoma
Laureate Institute for Brain Research Recruiting
Tulsa, Oklahoma, United States, 74136
Contact: Valerie Upshaw, RN         
Sponsors and Collaborators
Laureate Institute for Brain Research, Inc.
Investigators
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Principal Investigator: Sahib Khalsa, MD, PhD Laureate Institute for Brain Research
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Responsible Party: Laureate Institute for Brain Research, Inc.
ClinicalTrials.gov Identifier: NCT03610451    
Other Study ID Numbers: 2018-001-02
First Posted: August 1, 2018    Key Record Dates
Last Update Posted: August 20, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Laureate Institute for Brain Research, Inc.:
Anorexia nervosa
Floatation therapy
Additional relevant MeSH terms:
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Anorexia
Anorexia Nervosa
Signs and Symptoms, Digestive
Signs and Symptoms
Feeding and Eating Disorders
Mental Disorders