Floatation-REST, EFT, and IFT for Anorexia

Overseen By Emily M Choquette, PhD

Age: < 65

Sex: Female

Trial Phase: Academic

Sponsor: Laureate Institute for Brain Research, Inc.

Must not be taking: Psychiatric medications

Disqualifiers: Suicidal ideation, Pregnancy, Bipolar, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: 3 sessions

102 Participants Needed

Trial Summary

What is the purpose of this trial?

The proposed study utilizes a randomized experimental therapeutics design to test a mechanistic framework linking interoceptive processing and disturbed body image, with the purpose of informing the development of future therapies for body image dissatisfaction in anorexia nervosa (AN). A sample of 102 participants will be recruited from the Laureate Eating Disorder Program (LEDP). After being randomized, participants will all receive a one-hour session of acceptance- and mindfulness-based training with a therapist (the introduction session). They will then receive either the interoceptively focused treatment (IFT) or exteroceptively focused treatment (EFT) condition based on randomization. In the IFT condition participants will engage in floatation-REST (Reduced Environmental Stimulation Therapy) while practicing acceptance and mindfulness-based principles. The EFT condition is an exteroceptive intervention in which participants will be asked to view pre-recorded videos of acceptance and mindfulness-based skills to aid in the practice of these skills. Each condition will consist of one introduction session and three experimental sessions. All participants will then return for follow-up measures. Assessed outcomes will include acute changes in body image disturbance (BID) and interoception. Further, longitudinal intervention effects on self-reported eating disorder symptoms, body image dissatisfaction, and interoception; behavioral measures of interoception and body image dissatisfaction; and resting state and interoceptive functioning during functional magnetic resonance imaging (fMRI) will be explored.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot start any new psychiatric medications in the week before randomization.

What data supports the effectiveness of the treatment Floatation-REST, EFT, and IFT for Anorexia?

Research suggests that Floatation-REST, which involves sensory deprivation, can reduce anxiety and improve body image in people with anorexia. This treatment has been shown to be safe and may help with symptoms like anxiety and body dissatisfaction. ^{1 2 3 4 5}

Is Floatation-REST safe for humans?

Research suggests that Floatation-REST is generally safe for humans, as studies have shown no adverse events and no evidence of orthostatic hypotension (a drop in blood pressure when standing up) in participants with anorexia nervosa. It also appears to reduce anxiety and blood pressure while improving body image and awareness of internal sensations. ^{1 2 5 6 7}

How does the treatment Floatation-REST differ from other treatments for anorexia nervosa?

Floatation-REST is unique because it involves sensory deprivation, which reduces sensory input to the brain, potentially lowering anxiety and improving body image and interoception (awareness of internal body sensations) in people with anorexia nervosa. Unlike traditional treatments that focus on nutrition and behavior, this therapy offers a non-pharmacological approach to address psychological symptoms. ^{1 2 3 5 6}

Research Team

Emily M Choquette, PhD

Principal Investigator

Laureate Institute for Brain Research

Eligibility Criteria

This trial is for individuals aged 15-40 with a primary diagnosis of anorexia nervosa, BMI >18.5, transitioning from acute to residential care. They must not have started new psychiatric meds within the last week and should exhibit body image dissatisfaction as indicated by specific scale scores.

Inclusion Criteria

English proficiency

My BMI is over 18.5.

I can walk on my own without help.

Exclusion Criteria

I have had a seizure in the last year.

Active cutting or skin lacerating behaviors

Systolic blood pressure > 160 mmHg

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Introduction Session

Participants receive a one-hour session of acceptance- and mindfulness-based training with a therapist

1 hour

1 visit (in-person)

Treatment

Participants receive either interoceptively focused treatment (IFT) or exteroceptively focused treatment (EFT) consisting of three sessions

3 sessions

3 visits (in-person)

Follow-up

Participants are monitored for changes in body image disturbance and interoception

2 weeks

Treatment Details

Interventions

• EFT
• Floatation-REST
• IFT

Trial Overview The study tests how interoceptive processing affects body image in anorexia nervosa patients. Participants will either undergo floatation-REST (IFT) or watch acceptance/mindfulness videos (EFT). Each receives one intro session and three experimental sessions followed by various assessments.

Participant Groups

Group I: Interoceptively Focused Treatment (IFT) Experimental Treatment 2 Interventions

The IFT intervention will guide participants through a tailored application of present-moment focus toward experiencing awareness and acceptance of bodily signals and defusing thoughts related to those signals. For example, participants will engage in several exercises to increase awareness of body sensations, thoughts, and emotions. IFT consists of one introduction session with a clinician (\~60 minutes) the introduction session was designed as a brief introduction to acceptance- and mindfulness-based concepts with guided practice exercises and closing time for participants to briefly process challenges to execution of exercises and the experience during the session. This is followed by three IFT sessions which combine acceptance- and mindfulness-based skills practice with floatation-REST (Reduced Environmental Stimulation Therapy via floatation).

Group II: Exteroceptively Focused Treatment (EFT) Active Control 1 Intervention

In the EFT condition, exercises are tailored toward experience of the present moment via external environment mindfulness (i.e., attending to experience) and defusion of thoughts. EFT consists of one introduction session with a clinician (\~60 minutes) the introduction session, similar in format to IFT, introduces acceptance- and mindfulness-based concepts. This is followed by three EFT sessions during which participants engage in brief guided skills training followed by video guided skills practice. The EFT condition is designed to increase awareness of the present moment and experience of the environment and view thoughts or emotions that may impact engagement with the current moment in a nonjudgmental way.

Floatation-REST is already approved in United States, Canada, European Union for the following indications:

Approved in United States as Floatation-REST for:

• Anxiety disorders
• Pain management
• Stress relief

Approved in Canada as Floatation Therapy for:

• Chronic pain
• Fibromyalgia
• Post-traumatic stress disorder (PTSD)

Approved in European Union as Sensory Deprivation Therapy for:

• Depression
• Anxiety
• Insomnia

Who Is Running the Clinical Trial?

Laureate Institute for Brain Research, Inc.

Lead Sponsor

Trials

53

Recruited

5,400+

Findings from Research

Floatation-REST significantly reduced body dissatisfaction and anxiety in women and girls with anorexia nervosa, showing immediate benefits after each session and lasting effects at a six-month follow-up, compared to standard care.

The study involved 68 participants who received either floatation-REST or usual care, with no reported adverse events, suggesting that this non-pharmacological treatment is safe and effective for addressing core symptoms of anorexia nervosa.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of floatation therapy on body image and anxiety in anorexia nervosa: a randomised clinical efficacy trial. Choquette, EM., Flux, MC., Moseman, SE., et al.[2023]

A study involving 21 outpatients with anorexia nervosa showed that Reduced Environmental Stimulation Therapy (REST) via floatation is safe and well-tolerated, with no adverse events or orthostatic hypotension observed during the sessions.

REST significantly reduced blood pressure, anxiety, and body image dissatisfaction, while enhancing awareness of certain interoceptive sensations, suggesting potential therapeutic benefits for individuals with anorexia nervosa.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reduced Environmental Stimulation in Anorexia Nervosa: An Early-Phase Clinical Trial. Khalsa, SS., Moseman, SE., Yeh, HW., et al.[2022]

A systematic review of 6 studies involving 176 patients with anorexia nervosa found that physical therapy and supervised exercise significantly improved muscle strength, eating behaviors, mood, and overall quality of life, with no reported adverse effects.

Specific interventions like strength training and body awareness therapy were particularly effective, leading to enhanced muscle strength and positive changes in body attitudes among patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical Therapy Interventions in Patients with Anorexia Nervosa: A Systematic Review. Minano-Garrido, EJ., Catalan-Matamoros, D., Gómez-Conesa, A.[2023]

Physical therapy, including aerobic and resistance training, significantly improves muscle strength, body mass index, and body fat percentage in patients with anorexia nervosa, based on a systematic review of 8 trials involving 213 patients.

Aerobic exercise, yoga, massage, and body awareness therapy effectively reduce eating pathology and depressive symptoms in both anorexia and bulimia nervosa patients, with no reported adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of physical therapy interventions for patients with anorexia and bulemia nervosa. Vancampfort, D., Vanderlinden, J., De Hert, M., et al.[2022]

The Kyoto Prefectural University of Medicine Behavior Therapy (KPT) was found to be the most effective treatment for anorexia nervosa among three different programs, leading to greater increases in body mass index (BMI) at all measured points.

KPT's success is likely due to its unique approach of using a liquid formula in early treatment stages, delaying target weight setting, and gradually lifting activity restrictions based on weight gain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A behavior therapy program combined with liquid nutrition designed for anorexia nervosa. Okamoto, A., Yamashita, T., Nagoshi, Y., et al.[2005]

In a randomized controlled trial involving 23 patients with anorexia nervosa (AN) or avoidant-restrictive food intake disorder (ARFID), the use of weighted blankets showed a greater decrease in anxiety levels compared to usual care, although the results were not statistically significant.

Weighted blankets may serve as a beneficial non-pharmacological intervention for reducing anxiety in patients with AN and ARFID, adding to the multidisciplinary treatment options available for these eating disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing the Impact of Weighted Blankets on Anxiety Among Patients With Anorexia Nervosa and Avoidant- Restrictive Food Intake Disorder: A Randomized Controlled Trial. Ohene, R., Logan, C., Loresto, F., et al.[2023]

This randomized clinical trial will assess the efficacy of family-based treatment with home treatment (FBT-HT) compared to standard outpatient family-based treatment (FBT) and FBT with mindfulness-based stress reduction (FBT-MBSR) in 90 adolescents with anorexia nervosa, aiming to improve weight and eating habits.

The study will also evaluate the feasibility and acceptability of FBT-HT, with the hypothesis that it will outperform both standard FBT and FBT-MBSR, while also addressing caregiver stress and family dynamics as factors influencing treatment effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home treatment as an add-on to family-based treatment for adolescents with anorexia nervosa compared with standard family-based treatment and home-based stress reduction training: study protocol for a randomized clinical trial. Besse-Flütsch, N., Bühlmann, C., Fabijani, N., et al.[2023]

References

1. England pubmed.ncbi.nlm.nih.gov

The impact of floatation therapy on body image and anxiety in anorexia nervosa: a randomised clinical efficacy trial. [2023]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Reduced Environmental Stimulation in Anorexia Nervosa: An Early-Phase Clinical Trial. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Physical Therapy Interventions in Patients with Anorexia Nervosa: A Systematic Review. [2023]

4. England pubmed.ncbi.nlm.nih.gov

A systematic review of physical therapy interventions for patients with anorexia and bulemia nervosa. [2022]

5. Australia pubmed.ncbi.nlm.nih.gov

A behavior therapy program combined with liquid nutrition designed for anorexia nervosa. [2005]

6. United States pubmed.ncbi.nlm.nih.gov

Assessing the Impact of Weighted Blankets on Anxiety Among Patients With Anorexia Nervosa and Avoidant- Restrictive Food Intake Disorder: A Randomized Controlled Trial. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Home treatment as an add-on to family-based treatment for adolescents with anorexia nervosa compared with standard family-based treatment and home-based stress reduction training: study protocol for a randomized clinical trial. [2023]