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Effects of Reduced Environmental Stimulation on Eating Disorders

Primary Purpose

Anorexia Nervosa

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Reduced environmental stimulation

About this trial

This is an interventional other trial for Anorexia Nervosa focused on measuring Reduced, Environmental, Stimulation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

Any of the following DSM-V disorders:
1. Schizophrenia Spectrum and Other Psychotic Disorders
2. Bipolar and Related Disorders
Currently being treated for their psychiatric condition as an inpatient.
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).
Morbid obesity (BMI > 40) or underweight (BMI < 17.5).
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).
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).
History of unstable liver or renal insufficiency; glaucoma; diabetes; significant and unstable cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, or metabolic disturbance.
Pregnancy as detected by a urine test.
Failure to adhere to "Pre-float checklist".
Non-correctable vision or hearing problems.

Sites / Locations

Laureate Institute for Brain Research

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Float

Arm Description

One arm only: restricted environmental stimulation

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Self-ratings of changes in emotional experience

Measured via self-report measure (Positive and Negative Affect Schedule X)

Self-ratings of changes in physical experience

Interoceptive and exteroceptive sensations, measured via visual analogue scale (e.g., 0 to 100)

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).

EEG changes during the float experience

May be measured during the first, second, and fourth float.

Heart rate variability during the float experience

Measured during the first, second, and fourth float.

Eating disorder severity

Measured via the Eating Disorder Examination Questionnaire

Trauma exposure

Measured via the Childhood Trauma Questionnaire

Self-ratings of changes in anxiety

Measured via self-report measure (Spielberger State-Trait Anxiety Index)

Self-ratings of anxiety sensitivity

Measured via the Anxiety Sensitivity Index

Full Information

NCT ID

NCT02801084

First Posted

May 18, 2016

Last Updated

April 9, 2022

Sponsor

Laureate Institute for Brain Research, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02801084

Brief Title

Effects of Reduced Environmental Stimulation on Eating Disorders

Official Title

Examining the Effects of Reduced Environmental Stimulation on Eating Disorders

Study Type

Interventional

2. Study Status

Record Verification Date

October 2020

Overall Recruitment Status

Completed

Study Start Date

April 2016 (undefined)

Primary Completion Date

October 19, 2017 (Actual)

Study Completion Date

October 19, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Laureate Institute for Brain Research, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Anorexia Nervosa

Keywords

Reduced, Environmental, Stimulation

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

21 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Float

Arm Type

Experimental

Arm Description

One arm only: restricted environmental stimulation

Intervention Type

Behavioral

Intervention Name(s)

Reduced environmental stimulation

Other Intervention Name(s)

Floating

Intervention Description

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.

Primary Outcome Measure Information:

Title

Orthostatic blood pressure

Description

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.

Time Frame

Immediately before and after each float session for 4 float sessions, spaced weekly to monthly for up to 16 weeks study duration

Secondary Outcome Measure Information:

Title

Self-ratings of changes in emotional experience

Description

Measured via self-report measure (Positive and Negative Affect Schedule X)

Time Frame

Immediately before and after each float session for 4 float sessions, spaced weekly to monthly for up to 16 weeks study duration

Title

Self-ratings of changes in physical experience

Description

Interoceptive and exteroceptive sensations, measured via visual analogue scale (e.g., 0 to 100)

Time Frame

Immediately before and after each float session for 4 float sessions, spaced weekly to monthly for up to 16 weeks study duration

Title

Body image

Description

Measured via Photographic Figure Rating Scale, Body Appreciation Scale, Body Image States Scale, Body Shape Questionnaire, visual analogue scale (e.g., 0 to 10).

Time Frame

Obtained at baseline and immediately after each float session for 4 float sessions, spaced weekly to monthly for up to 16 weeks study duration

Title

EEG changes during the float experience

Description

May be measured during the first, second, and fourth float.

Time Frame

During the first, second, and fourth float for 4 float sessions, spaced weekly to monthly for up to 16 weeks study duration

Title

Heart rate variability during the float experience

Description

Measured during the first, second, and fourth float.

Time Frame

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

Title

Eating disorder severity

Description

Measured via the Eating Disorder Examination Questionnaire

Time Frame

Obtained during the first visit

Title

Trauma exposure

Description

Measured via the Childhood Trauma Questionnaire

Time Frame

Obtained during the first visit

Title

Self-ratings of changes in anxiety

Description

Measured via self-report measure (Spielberger State-Trait Anxiety Index)

Time Frame

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

Title

Self-ratings of anxiety sensitivity

Description

Measured via the Anxiety Sensitivity Index

Time Frame

Obtained during the first visit

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Current or prior diagnosis of anorexia nervosa (AN) All AN participants must be weight-restored prior to their participation, defined as having a Body Mass Index (BMI) > 17.5 Exclusion Criteria: Any of the following DSM-V disorders: Schizophrenia Spectrum and Other Psychotic Disorders Bipolar and Related Disorders Currently being treated for their psychiatric condition as an inpatient. 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). Morbid obesity (BMI > 40) or underweight (BMI < 17.5). 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). 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). History of unstable liver or renal insufficiency; glaucoma; diabetes; significant and unstable cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, or metabolic disturbance. Pregnancy as detected by a urine test. Failure to adhere to "Pre-float checklist". Non-correctable vision or hearing problems.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sahib S 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

Undecided

Citations:

PubMed Identifier

33123048

Citation

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.

Results Reference

result

Links:

URL

https://doi.org/10.3389/fpsyg.2020.567499

Description

DOI for publication summarizing study results.

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Effects of Reduced Environmental Stimulation on Eating Disorders

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