Floatation-REST and Anorexia Nervosa

Laureate Institute for Brain Research (LIBR)

Status: Active, not recruiting

Conditions: Anorexia Nervosa

Treatments: Behavioral: Usual care; Behavioral: Floatation-REST plus usual care

Study type: Interventional

Funder types: Other

Identifiers

NCT03610451

2018-001-02

Details and patient eligibility

About

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

Full 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.

Enrollment: 68 patients

Sex: Female

Ages: 13 to 64 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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68 participants in 2 patient groups

Floatation-REST

Experimental group

Description:

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.

Treatment:

Behavioral: Floatation-REST plus usual care

Usual care

Other group

Description:

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.

Treatment:

Behavioral: Usual care