Floatation-REST and Anorexia Nervosa

NCT03610451 | Unknown

• 1 other identifier: 2018-001-02
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

The study proposed in this protocol aims to document the effect of Floatation-REST (reduced environmental stimulation therapy) on symptoms of anorexia nervosa.

Conditions

Anorexia Nervosa

Keywords

Anorexia nervosa; Floatation therapy

Outcome Measures

Primary Outcomes (1)

• Body image dissatisfaction score on the Photographic Figure Rating Scale

  Average of the absolute change in body image dissatisfaction from pre to post float across all eight floats (score range: 0 to 10; larger changes indicate greater severity of body image dissatisfaction)

  Through study completion, an average of 1 year

Secondary Outcomes (8)

• Anxiety on the Spielberger State Trait Anxiety Inventory

  Through study completion, an average of 1 year

• Anxiety on the NIH Promis Anxiety Scale

  Through study completion, an average of 1 year

• Anxiety sensitivity on the Anxiety Sensitivity Index-3R

  Through study completion, an average of 1 year

• Eating disorder severity on the Eating Disorder Examination Questionnaire

  Through study completion, an average of 1 year

• Functional ability on the Sheehan Disability Questionnaire

  Through study completion, an average of 1 year

Study Arms (2)

Floatation-REST

EXPERIMENTAL

Participants will float supine in a pool of water saturated with epsom salt, in a light and sound attenuated chamber, for up to 60 minutes, on 8 separate occasions. Ratings of the experience will be collected before and after each float.

Behavioral: Floatation-REST plus usual care

Usual care

OTHER

Participants will be assessed along the same time periods, i.e., before and after a 60 minute window, on 8 separate occasions. Ratings of the experience will be collected before and after each time period.

Behavioral: Usual care

Interventions

Floatation-REST plus usual care BEHAVIORAL

Individuals will receive Floatation-REST plus usual care. Floating creates an environment with minimal visual, auditory, tactile, proprioceptive, and thermal input to the brain. The float rooms are lightproof and soundproof. 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.

Floatation-REST

Usual care BEHAVIORAL

Individuals will receive usual care on the inpatient unit of the Laureate Eating Disorders Program.

Usual care

Eligibility Criteria

• Age: 13 Years - 64 Years
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Primary clinical diagnosis of anorexia nervosa
• Receiving inpatient treatment for eating disorder
• Body mass index greater than or equal to 16
• No new medication prescription in the week prior to study randomization
• Independently ambulatory
• No current evidence of orthostatic hypotension
• Ability to lay flat comfortably
• Possession of a smartphone with data plan
• English proficiency

You may not qualify if:

• Active suicidal ideation
• Active cutting or skin lacerating behaviors
• Orthostatic hypotension (defined as a drop of ≥ 20 mm Hg in systolic BP or a drop of ≥ 10 mm Hg in diastolic BP when measured shortly after transitioning from lying down to standing)
• Comorbid schizophrenia spectrum or other psychotic disorder

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)

• Choquette EM, Flux MC, Moseman SE, Chappelle S, Naegele J, Upshaw V, Morton A, Paulus MP, Feinstein JS, Khalsa SS. The impact of floatation therapy on body image and anxiety in anorexia nervosa: a randomised clinical efficacy trial. EClinicalMedicine. 2023 Aug 29;64:102173. doi: 10.1016/j.eclinm.2023.102173. eCollection 2023 Oct.

  PMID: 37936658 DERIVED

MeSH Terms

Conditions

Anorexia Nervosa

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders

Study Officials

• Sahib Khalsa, MD, PhD

  Laureate Institute for Brain Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pragmatic randomized controlled trial

Study Record Dates

• First Submitted: March 19, 2018
• First Posted: August 1, 2018
• Study Start: March 16, 2018
• Primary Completion: March 1, 2022
• Study Completion: October 1, 2024
• Last Updated: October 5, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)