Effects of Reduced Environmental Stimulation on Eating Disorders

Not Applicable

Completed

• Conditions: Anorexia Nervosa
• Interventions: Behavioral: Reduced environmental stimulation

• Registration Number: NCT02801084
• Lead Sponsor: Laureate Institute for Brain Research, Inc.

Brief Summary

The study proposed in this protocol aims to document the physiological, subjective, behavioral, and neural effects of reduced environmental stimulation (floating) in patients with current or prior anorexia nervosa The primary aim of this study is to determine the safety of this intervention. Secondary aims including determining whether floating has an impact on symptom reports such as those related to anxiety and eating disorders.

Detailed Description

Floating creates an environment with minimal visual, auditory, tactile, proprioceptive, and thermal input to the brain. The float rooms used in this study are both lightproof, and thus completely dark when the entry door is sealed and the lights are turned off, reducing all visual input to the brain. Each float room was constructed with thick soundproof walls, restricting most outside noises from entering the room, thereby reducing auditory input to the brain. 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.

While both float pools dramatically reduce external sensory information, it is important to note that participants are in full control over the experience. For example, participants can enter and exit the float pool whenever they choose. Each float pool also contains a blue LED light that can be turned on and off via an air-coupled light switch in the pool. Both float rooms contain a shower for cleaning before and after floating.

In a prior study the investigators have found that healthy participants found the pool condition to be relaxing and stress relieving. The current study aims to determine the safety of floating with a clinical population, specifically individuals with a history of eating disorder who are of normal weight.

Study Timeline

• Study Start: 2016-04
• Study First Submitted: 2016-05-18
• Study First Submitted QC: 2016-06-10
• Study First Posted: 2016-06-15
• Primary Completion: 2017-10-19
• Study Completion: 2017-10-19
• Status Verified: 2020-10
• Last Update Submitted: 2022-04-09
• Last Update Posted: 2022-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

1. Current or prior diagnosis of anorexia nervosa (AN)
2. All AN participants must be weight-restored prior to their participation, defined as having a Body Mass Index (BMI) > 17.5

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Exclusion Criteria

1. Any of the following DSM-V disorders:

   1. Schizophrenia Spectrum and Other Psychotic Disorders
   2. Bipolar and Related Disorders

2. Currently being treated for their psychiatric condition as an inpatient.

3. Active suicidal ideation with intent or plan (as determined by a psychiatrist or clinical psychologist for all participants who report an IDAS-II suicide score > 10).

4. Morbid obesity (BMI > 40) or underweight (BMI < 17.5).

5. Orthostatic hypotension (defined as a drop of ≥20 mm Hg in systolic blood pressure or a drop of ≥10 mm Hg in diastolic blood pressure when measured shortly after transitioning from lying down to standing).

6. Certain drugs or medications consumed within the past week including any psychoactive drugs (e.g., MDMA, LSD, psilocybin, peyote, phencyclidine, ketamine), magnesium supplements (greater than 150mg) or milk of magnesia. Any antihistamine that causes drowsiness (e.g., Benadryl) or any alcohol consumed within the past 12 hours. Caffeine or nicotine consumed within the past 3 hours. For all other medications, participants must be stably medicated prior to participation (defined as having taken the medication for 6 weeks or longer).

7. History of unstable liver or renal insufficiency; glaucoma; diabetes; significant and unstable cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, or metabolic disturbance.

8. Pregnancy as detected by a urine test.

9. Failure to adhere to "Pre-float checklist".

10. Non-correctable vision or hearing problems.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Float	Reduced environmental stimulation	One arm only: restricted environmental stimulation

Primary Outcome Measures

Name	Time	Method
Orthostatic blood pressure	Immediately before and after each float session for 4 float sessions, spaced weekly to monthly for up to 16 weeks study duration	Defined as a drop of ≥20 mm Hg in systolic blood pressure or a drop of ≥10 mm Hg in diastolic blood pressure when measured shortly after transitioning from lying down to standing.

Secondary Outcome Measures

Name	Time	Method
Body image	Obtained at baseline and immediately after each float session for 4 float sessions, spaced weekly to monthly for up to 16 weeks study duration	Measured via Photographic Figure Rating Scale, Body Appreciation Scale, Body Image States Scale, Body Shape Questionnaire, visual analogue scale (e.g., 0 to 10).
EEG changes during the float experience	During the first, second, and fourth float for 4 float sessions, spaced weekly to monthly for up to 16 weeks study duration	May be measured during the first, second, and fourth float.
Eating disorder severity	Obtained during the first visit	Measured via the Eating Disorder Examination Questionnaire
Self-ratings of changes in anxiety	Obtained at baseline and immediately before and after each float session for 4 float sessions, spaced weekly to monthly for up to 16 weeks study duration	Measured via self-report measure (Spielberger State-Trait Anxiety Index)
Trauma exposure	Obtained during the first visit	Measured via the Childhood Trauma Questionnaire
Self-ratings of anxiety sensitivity	Obtained during the first visit	Measured via the Anxiety Sensitivity Index
Self-ratings of changes in emotional experience	Immediately before and after each float session for 4 float sessions, spaced weekly to monthly for up to 16 weeks study duration	Measured via self-report measure (Positive and Negative Affect Schedule X)
Self-ratings of changes in physical experience	Immediately before and after each float session for 4 float sessions, spaced weekly to monthly for up to 16 weeks study duration	Interoceptive and exteroceptive sensations, measured via visual analogue scale (e.g., 0 to 100)
Heart rate variability during the float experience	Obtained at baseline and after the first, second, and fourth float for 4 float sessions, spaced weekly to monthly for up to 16 weeks study duration	Measured during the first, second, and fourth float.

Trial Locations

Locations (1)

Laureate Institute for Brain Research; 🇺🇸 Tulsa, Oklahoma, United States