Anorexia NervosaNCT03610451
Floatation-REST and Anorexia Nervosa
A study of Anorexia Nervosa, run by Laureate Institute for Brain Research, Inc. at 1 site in United States.
Trial summary
The study proposed in this protocol aims to document the effect of Floatation-REST (reduced environmental stimulation therapy) on symptoms of anorexia nervosa. Read more about this study
- Who is it for?
- Ages 13 to 64 years, women only
- Conditions the study is for
- Anorexia Nervosa
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Mar 2018to Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 64 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Show all 9Show fewer
- Ability to lay flat comfortably
- Possession of a smartphone with data plan
- English proficiency
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Laureate Institute for Brain Research
Tulsa, Oklahoma, 74136
About this study
Official title: Influence of Floatation-REST (Reduced Environmental Stimulation Therapy) on Anorexia Nervosa
The study proposed in this protocol aims to document the effect of Floatation-REST (reduced environmental stimulation therapy) on symptoms of anorexia nervosa.
Read the 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.
- Conditions
- Anorexia Nervosa
- Being tested
- Floatation-REST plus usual care, Usual care
- Keywords
- Anorexia nervosa, Floatation therapy
- Medical subject headings
- Anorexia Nervosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Floatation-REST plus usual careBehavioural
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.
Usual careBehavioural
Individuals will receive usual care on the inpatient unit of the Laureate Eating Disorders Program.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Through study completion, an average of 1 year
Secondary outcomes (8)
Anxiety on the Spielberger State Trait Anxiety Inventory
Average of the change in anxiety rating from pre to post float across all eight float (range 20 to 80, higher scores indicate greater severity of anxiety)
Measured: Through study completion, an average of 1 year
Anxiety on the NIH Promis Anxiety Scale
Average of the change in anxiety rating from pre to post float across all eight float (range 6 to 30, higher scores indicate greater severity of anxiety)
Measured: Through study completion, an average of 1 year
Anxiety sensitivity on the Anxiety Sensitivity Index-3R
Change in anxiety sensitivity after the final float relative to baseline (range 0 to 96, higher scores indicate greater severity of anxiety sensitivity)
Measured: Through study completion, an average of 1 year
Eating disorder severity on the Eating Disorder Examination Questionnaire
Change in eating disorder severity after the final float relative to baseline (range 0 to 6, larger scores indicate greater severity of eating disorder)
Measured: Through study completion, an average of 1 year
Functional ability on the Sheehan Disability Questionnaire
Change in functional ability after the final float relative to baseline (range 0 to 30, higher scores indicate greater severity of disability)
Measured: Through study completion, an average of 1 year
Body image disturbance on the Body Image States Scale
Change in body image disturbance after the final float relative to baseline (range 0 to 48, higher scores indicate greater severity of body image disturbance)
Measured: Through study completion, an average of 1 year
Interoceptive self report on the Multidimensional Interoceptive Awareness Scale
Change in total interoceptive awareness score after the final float relative to baseline (range 0 to 160, higher scores indicating greater interoceptive awareness)
Measured: Through study completion, an average of 1 year
Body image disturbance on the Body Appreciation Scale-2
Change in body image disturbance score after the final float relative to baseline (range 10 to 50, higher scores indicating reduced severity of body image disturbance)
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2018
- Study start16 Mar 2018
- Primary completion1 Mar 2022
- Study completionOct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anorexia NervosaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pragmatic randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laureate Institute for Brain Research, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sahib Khalsa, MD, PhD, Principal investigator, Laureate Institute for Brain Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03610451
- Sponsor's protocol ID
- 2018-001-02
- Status last verified
- Oct 2023
- First submitted
- 19 Mar 2018
- Last updated
- 5 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37936658
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Floatation-REST (Reduced Environmental Stimulation Therapy) on Anorexia Nervosa
- ClinicalTrials.gov ID
- NCT03610451
- Acronym / sponsor ID
- 2018-001-02
- Conditions
- Anorexia Nervosa
- Keywords
- Anorexia nervosa, Floatation therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Laureate Institute for Brain Research, Inc.University, hospital or other
- Study start
- 16 Mar 2018 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- Oct 2024 (estimated)
- First posted
- 1 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Pragmatic randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Floatation-REST | Experimental | Behavioral: Floatation-REST plus usual careParticipants 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. |
| Usual care | Other | Behavioral: Usual careParticipants 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. |
Who may qualify
- Ages
- 13 to 64 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Floatation-REST plus usual careIndividuals 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. | Behavioural | Floatation-REST |
| Usual careIndividuals will receive usual care on the inpatient unit of the Laureate Eating Disorders Program. | Behavioural | Usual care |
Primary outcome
Body image dissatisfaction score on the Photographic Figure Rating Scale
Time frame: Through study completion, an average of 1 year
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)
8 secondary outcomes
Anxiety on the Spielberger State Trait Anxiety Inventory
Time frame: Through study completion, an average of 1 year
Anxiety on the NIH Promis Anxiety Scale
Time frame: Through study completion, an average of 1 year
Anxiety sensitivity on the Anxiety Sensitivity Index-3R
Time frame: Through study completion, an average of 1 year
Eating disorder severity on the Eating Disorder Examination Questionnaire
Time frame: Through study completion, an average of 1 year
Functional ability on the Sheehan Disability Questionnaire
Time frame: Through study completion, an average of 1 year
Body image disturbance on the Body Image States Scale
Time frame: Through study completion, an average of 1 year
Interoceptive self report on the Multidimensional Interoceptive Awareness Scale
Time frame: Through study completion, an average of 1 year
Body image disturbance on the Body Appreciation Scale-2
Time frame: Through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2023.
- Derived from this study: PubMed 37936658Choquette 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sahib Khalsa, MD, PhD principal investigator
Laureate Institute for Brain Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Anorexia Nervosa, run by Laureate Institute for Brain Research, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body image dissatisfaction score on the Photographic Figure Rating Scale (time frame: Through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03610451, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2023; AzTrials last refreshed its copy on 31 Oct 2026.