Effects of Reduced Environmental Stimulation on Eating Disorders

Examining the Effects of Reduced Environmental Stimulation on Eating Disorders

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.

Study Overview

• Status: Completed
• Conditions: Anorexia Nervosa
• Intervention / Treatment: Behavioral: Reduced environmental stimulation

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 Type: Interventional
• Enrollment (Actual): 21
• 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: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Float; One arm only: restricted environmental stimulation

Behavioral: Reduced environmental stimulation; Participants will complete one arm involving four sequential float sessions. Float 1: chair float. Participants will first float in a comfortable chair in the supine position, for up to 90 minutes. The chair is in a room with sound and light attenuation. Orthostatic blood pressure (BP) will be measured before and after each float. Anxiety and body image will be measured afterwards. Float 2: open pool float. Participants will float for up to 90 minutes in an open pool (8 foot diameter, no enclosure). Orthostatic BP will be measured before and after each float. Anxiety and body image will be measured afterwards. Floats 3 & 4: domed pool float. Participants will float for up to 90 minutes in a domed pool the same size as the open pool, with an enclosure wall and 8 foot tall ceiling. Orthostatic BP will be measured before and after each float. Anxiety and body image will be measured afterwards. Each float will occur approximately 1 to 7 days apart.; Other Names: Floating

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Orthostatic blood pressure	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.	Immediately before and after each float session for 4 float sessions, spaced weekly to monthly for up to 16 weeks study duration

Secondary Outcome Measures

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

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Khalsa SS, Moseman SE, Yeh HW, Upshaw V, Persac B, Breese E, Lapidus RC, Chappelle S, Paulus MP, Feinstein JS. Reduced Environmental Stimulation in Anorexia Nervosa: An Early-Phase Clinical Trial. Front Psychol. 2020 Oct 6;11:567499. doi: 10.3389/fpsyg.2020.567499. eCollection 2020.

Helpful Links

• DOI for publication summarizing study results.

Study record dates

Study Major Dates

• Study Start: April 1, 2016
• Primary Completion (Actual): October 19, 2017
• Study Completion (Actual): October 19, 2017

Study Registration Dates

• First Submitted: May 18, 2016
• First Submitted That Met QC Criteria: June 10, 2016
• First Posted (Estimate): June 15, 2016

Study Record Updates

• Last Update Posted (Actual): April 15, 2022
• Last Update Submitted That Met QC Criteria: April 9, 2022
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Stimulation; Environmental; Reduced
• Additional Relevant MeSH Terms: Mental Disorders; Signs and Symptoms, Digestive; Anorexia; Anorexia Nervosa; Feeding and Eating Disorders
• Other Study ID Numbers: 2015-002-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED