Effects of Reduced Environmental Stimulation on Eating Disorders

Anorexia Nervosa Clinical Trial

Official title:

Examining the Effects of Reduced Environmental Stimulation on Eating Disorders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02801084
• Other study ID #: 2015-002-01
• Status: Completed
• Phase: N/A
• Start date: April 2016
• Est. completion date: October 19, 2017

Study information

• Verified date: October 2020
• Source: Laureate Institute for Brain Research, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: October 19, 2017
• Est. primary completion date: October 19, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anorexia
• Anorexia Nervosa
• Feeding and Eating Disorders

Intervention

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.

Locations

Country	Name	City	State
United States	Laureate Institute for Brain Research	Tulsa	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
Laureate Institute for Brain Research, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

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.20 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Eating disorder severity	Measured via the Eating Disorder Examination Questionnaire	Obtained during the first visit
Secondary	Trauma exposure	Measured via the Childhood Trauma Questionnaire	Obtained during the first visit
Secondary	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
Secondary	Self-ratings of anxiety sensitivity	Measured via the Anxiety Sensitivity Index	Obtained during the first visit

External Links

•   DOI for publication summarizing study results.