Clinical trial NCT03610451: Floatation-REST and Anorexia Nervosa
Official title: Influence of Floatation-REST (Reduced Environmental Stimulation Therapy) on Anorexia Nervosa
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Anorexia Nervosa
Keywords: Anorexia nervosa
Floatation therapy
Lead sponsor: Laureate Institute for Brain Research, Inc.
Sponsor class: OTHER
First posted: 2018-08-01
Enrollment: 68
Sex: FEMALE
Minimum age (years): 13
Maximum age (years): 64
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pragmatic randomized controlled trial
Primary purpose: TREATMENT

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.

Detailed description: Flotation-REST (reduced environmental stimulation therapy) alters the balance of sensory input by systematically attenuating signals from the visual, auditory, thermal, tactile, vestibular, and proprioceptive systems. Previous research has shown that this heightens interoceptive awareness and reduces anxiety in clinically anxious populations. Anorexia nervosa (AN) is characterized by elevated anxiety, distorted body image, and disrupted interoception, raising the question of whether floatation therapy might positively impact these symptoms. A recent safety study found that Floatation-REST was well tolerated by individuals weight-restored outpatients with current or prior AN. Additionally, participants reported improvements in affective state and body image disturbance following floating, raising the possibility that this intervention might be investigated for clinical benefit in more acutely ill cases.

The primary aim of this study is to begin to examine the effect of Floatation-REST on body image disturbance in inpatients with AN. Secondary aims including determining whether Floatation-REST has an impact on anxiety, emotional distress, eating disorder severity, functional ability, and interoception.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Body image dissatisfaction score on the Photographic Figure Rating Scale
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Anxiety on the Spielberger State Trait Anxiety Inventory
timeFrame: Through study completion, an average of 1 year
measure: Anxiety on the NIH Promis Anxiety Scale
timeFrame: Through study completion, an average of 1 year
measure: Anxiety sensitivity on the Anxiety Sensitivity Index-3R
timeFrame: Through study completion, an average of 1 year
measure: Eating disorder severity on the Eating Disorder Examination Questionnaire
timeFrame: Through study completion, an average of 1 year
measure: Functional ability on the Sheehan Disability Questionnaire
timeFrame: Through study completion, an average of 1 year
measure: Body image disturbance on the Body Image States Scale
timeFrame: Through study completion, an average of 1 year
measure: Interoceptive self report on the Multidimensional Interoceptive Awareness Scale
timeFrame: Through study completion, an average of 1 year
measure: Body image disturbance on the Body Appreciation Scale-2
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Tulsa
country: United States
facility: Laureate Institute for Brain Research
state: Oklahoma
Study officials:
affiliation: Laureate Institute for Brain Research
name: Sahib Khalsa, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: