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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore new treatments for body image issues in individuals with anorexia nervosa. Participants will engage in one of two therapies: Floatation-REST, which uses floatation tanks to help individuals focus on internal feelings, or a video-based therapy that encourages focus on the external world. The goal is to assess how these treatments impact body image and self-perception. This trial suits those with anorexia nervosa who struggle with body image and can attend sessions at the clinic. As an unphased trial, it offers participants the chance to contribute to pioneering research in innovative therapies for anorexia nervosa.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that Floatation-REST is generally safe for people. Studies indicate it is well-tolerated, does not cause side effects, and does not lower blood pressure. This treatment has even been safely used by individuals with anxiety and depression.

The Interoceptively Focused Treatment (IFT) uses Floatation-REST to enhance awareness of body signals, combining it with mindfulness, which involves focusing on the present moment. The Exteroceptively Focused Treatment (EFT) also incorporates mindfulness, but through videos that teach these skills.

Both treatments aim to improve body awareness and acceptance. Evidence so far suggests they are safe, with no serious side effects reported in related studies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative approaches to treating anorexia that focus on mindfulness and sensory experience. Unlike traditional treatments that often involve nutritional rehabilitation and psychological therapies, this trial examines two unique methods: Interoceptively Focused Treatment (IFT) and Exteroceptively Focused Treatment (EFT). IFT combines mindfulness with Floatation-REST, a technique that uses sensory deprivation to enhance awareness and acceptance of bodily signals. Meanwhile, EFT emphasizes mindfulness through engagement with the external environment, helping participants become more aware of their surroundings and thoughts. These approaches aim to offer new pathways for patients to process and respond to their bodily experiences and thoughts, potentially opening doors to more personalized and effective treatments for anorexia.

What evidence suggests that this trial's treatments could be effective for anorexia?

Research has shown that Floatation-REST, part of the Interoceptively Focused Treatment (IFT) arm in this trial, may reduce symptoms of anorexia nervosa. Studies have found that Floatation-REST can lessen body dissatisfaction immediately after sessions and continue to do so for up to six months. Therapies focusing on the body, like this one, often improve body image and aid emotional control in individuals with eating disorders.

For participants in the Exteroceptively Focused Treatment (EFT) arm, research indicates that therapies focusing on emotions can improve symptoms of eating disorders and enhance emotional well-being. EFT uses mindfulness and acceptance exercises guided by videos, and similar therapies have successfully reduced distress related to eating and improved emotional stability. Both treatments in this trial aim to help individuals better understand and manage their feelings about their bodies and emotions. ^{1 3 4 6 7}

Who Is on the Research Team?

Emily M Choquette, PhD

Principal Investigator

Laureate Institute for Brain Research

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

Citations

1. withpower.com withpower.com/trial/phase-anorexia-3-2024-ed36f

Floatation-REST, EFT, and IFT for Anorexia A systematic review of 6 studies involving 176 patients with anorexia nervosa found that physical therapy and supervised exercise significantly improved muscle ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12131494/

Predicting anorexia nervosa treatment efficacy - PubMed Central This data-driven approach offers an unbiased means to uncover predictors of specific outcomes, advancing the understanding and management of this challenging ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2589537023003504

The impact of floatation therapy on body image and anxiety ... Our findings suggest that Floatation-REST decreased body dissatisfaction compared to care as usual acutely after each float session and at six-month follow-up.

4. withpower.com withpower.com/clinical-trials/for-anorexia-nervosa

Top Anorexia Nervosa Clinical Trials | Power 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 ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34779059/

Efficacy of emotion-focused therapy in the treatment ... It seems that the results coincide in the existence of post-treatment improvements both in eating psychopathology and in affective symptoms.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10626164/

The impact of floatation therapy on body image and anxiety in ... This study examined the efficacy of a novel non-pharmacological treatment, floatation-REST (Reduced Environmental Stimulation Therapy) on body image ...

7. nature.com nature.com/articles/s41398-022-02102-w

Efficacy and safety of deep brain stimulation for treatment ... Primary outcome was Body Mass Index (BMI), secondary outcome was quality of life, and the severity of psychiatric symptoms, including eating ...