Effects of Reduced Environmental Stimulation on Eating Disorders

NCT02801084 | Completed

• 1 other identifier: 2015-002-01
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Anorexia Nervosa

Keywords

Reduced; Environmental; Stimulation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• 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

• 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

• 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

• 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

• 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

Study Arms (1)

Float

EXPERIMENTAL

One arm only: restricted environmental stimulation

Behavioral: Reduced environmental stimulation

Interventions

Reduced environmental stimulation BEHAVIORAL

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.

Also known as: Floating

Float

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Laureate Institute for Brain Research, Inc.: lead

Study Sites (1)

Laureate Institute for Brain Research

Tulsa, Oklahoma, 74136, United States

Location

Related 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.2020.567499. eCollection 2020.

  PMID: 33123048 RESULT

Related Links

• DOI for publication summarizing study results.

MeSH Terms

Conditions

Anorexia Nervosa

Interventions

Divorce

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Marital Status; Family Characteristics; Demography; Population Characteristics; Socioeconomic Factors

Study Officials

• Sahib S Khalsa, MD, PhD

  Laureate Institute for Brain Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2016
• First Posted: June 15, 2016
• Study Start: April 1, 2016
• Primary Completion: October 19, 2017
• Study Completion: October 19, 2017
• Last Updated: April 15, 2022

Record last verified: 2020-10

Locations

US (1)