Interoceptive Exposure for Eating Disorders

Overseen By Thomas Hildebrandt, Psy.D

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Icahn School of Medicine at Mount Sinai

Disqualifiers: Psychotic, Bipolar, Suicidal, Substance dependence, others

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

Compensation: Varies

Number of Visits: 22

Duration: 6 months

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two psychological treatments for teenagers with low-weight eating disorders. It examines how Interoceptive Exposure Treatment (IE), which focuses on confronting food and body image fears, compares to Family-Based Therapy (FBT), where families encourage eating and reduce food avoidance. The goal is to determine which treatment more effectively improves body weight and reduces the impact of eating disorders on daily life. Teens aged 12-18 who struggle with food intake and maintaining a healthy weight might be suitable candidates for this trial. As an unphased trial, this study provides a unique opportunity for teens to contribute to important research that could shape future treatment approaches.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you recently started psychiatric medication or changed the dosage within the last two weeks, you may not be eligible to participate.

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

Research shows that both Interoceptive Exposure Treatment (IE) and Family-Based Treatment (FBT) are generally safe for treating eating disorders. IE, particularly in teenagers, has shown promise with few reported side effects. This treatment involves gradually confronting avoided situations, such as certain foods or body image concerns, and has been successfully used in other exposure therapies for eating disorders.

FBT is well-tolerated and serves as a leading treatment for teenagers with anorexia nervosa. Studies have demonstrated FBT's effectiveness and safety, emphasizing family involvement in the recovery process. This approach is widely used and has strong evidence supporting its safety.

Both treatments aim to help patients gain healthy weight and improve their relationship with food. While individual experiences may vary, research supports the safety of these therapies for people with eating disorders. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Interoceptive Exposure Treatment (IE) for eating disorders because it introduces a unique approach by directly targeting food avoidance and body image issues through exposure therapy. Unlike standard treatments that often focus on nutritional rehabilitation or cognitive restructuring, IE actively engages patients with their physical sensations and emotions related to eating. This method aims to reduce anxiety and avoidance behaviors by gradually increasing comfort with distressing feelings, potentially offering a more integrated and sustainable path to recovery. Meanwhile, Family-Based Treatment (FBT) remains a powerful comparator, emphasizing family involvement to change eating behaviors and attitudes toward food, enhancing the overall treatment landscape for eating disorders.

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

Research has shown that Family-Based Treatment (FBT), one of the treatments in this trial, ranks among the top methods for treating eating disorders in teenagers, such as anorexia nervosa. It effectively involves parents in helping their children regain a healthy weight and eating habits. Studies also highlight its success in treating binge-eating disorder.

Interoceptive Exposure (IE) is another therapy under study in this trial for its potential to treat eating disorders in underweight individuals. It involves directly confronting fears related to food and body image. Early research suggests that combining IE with FBT could enhance treatment by reducing food avoidance and increasing body awareness. ^{1 2 3 5 6}

Who Is on the Research Team?

Thomas Hildebrandt, Psy.D.

Principal Investigator

Icahn School of Medicine at Mount Sinai

Are You a Good Fit for This Trial?

This trial is for English-speaking adolescents aged 12-18 with low weight eating disorders like anorexia. They must have a doctor's permission for outpatient care, show significant food intake restriction or avoidance, and be unable to maintain a healthy body weight. Those with substance dependence, bipolar/psychotic disorders, recent psychiatric medication changes, major medical illnesses, or active suicidal thoughts cannot join.

Inclusion Criteria

Permission from pediatrician or equivalent to receive outpatient care

I have a significant problem with eating or avoiding food.

Evidence of the inability to maintain greater than minimally low body weight based on BMI for age percentiles and growth trajectories

Exclusion Criteria

I haven't started or changed any psychiatric meds in the last 2 weeks.

I have a major medical condition like diabetes or Crohn's disease.

I am currently having thoughts about harming myself.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Exposure-based Family Therapy (IE) or Family-Based Therapy (FBT) for low weight eating disorders

6 months

20 sessions (outpatient)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Assessments at 2-, 4-, 6-, 12-, and 18-months following baseline

What Are the Treatments Tested in This Trial?

Interventions

• Family-Based Treatment (FBT)
• Interoceptive Exposure Treatment (IE)

Trial Overview The study compares two psychological treatments: Interoceptive Exposure-based Family Therapy (IE) and standard Family-Based Treatment (FBT). It aims to see which treatment better helps teens reach expected body weight without clinical impairment over a year. The study also looks at how these therapies work by focusing on autonomous eating habits, non-judgmental body awareness, and learning to overcome fear responses related to eating.

How Is the Trial Designed?

Group I: Interoceptive Exposure Treatment (IE) Experimental Treatment 1 Intervention

Interoceptive Exposure Therapy (IE) targets food avoidance, food exposure, and body image exposure.

Group II: Family-Based Treatment (FBT) Active Control 1 Intervention

Family-Based Therapy (FBT) focuses on parent-enforced contingencies, increasing value of eating, and decreasing the value of food avoidance.

Family-Based Treatment (FBT) is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Family-Based Treatment for:

• Anorexia Nervosa
• Other Eating Disorders

Approved in United States as Family-Based Treatment for:

• Anorexia Nervosa
• Other Eating Disorders

Approved in Canada as Family-Based Treatment for:

• Anorexia Nervosa
• Other Eating Disorders

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials

933

Recruited

579,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Published Research Related to This Trial

Family-based treatment (FBT) was found to be significantly more effective than enhanced cognitive-behavior therapy (CBT-E) in promoting weight gain among adolescents with eating disorders, particularly at the end of treatment.

Both FBT and CBT-E showed similar outcomes in terms of eating disorder symptoms and other measures, indicating that CBT-E is also a viable treatment option for adolescents, especially for those who may prefer it.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhanced cognitive-behavior therapy and family-based treatment for adolescents with an eating disorder: a non-randomized effectiveness trial. Le Grange, D., Eckhardt, S., Dalle Grave, R., et al.[2022]

Family-based treatment (FBT) is becoming a preferred method for treating adolescent anorexia nervosa (AN) and bulimia nervosa (BN), showing promising outcomes in clinical studies.

The review discusses the suitability of FBT for various adolescent groups and family dynamics, suggesting that while FBT is effective, its application may need to be tailored for older adolescents and those with comorbid conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Family-Based Treatment for Adolescent Eating Disorders: Current Status, New Applications and Future Directions. Loeb, KL., le Grange, D.[2022]

Family-based treatment (FBT) for eating disorders in adolescents emphasizes the involvement of parents in the recovery process, which is crucial given the vulnerability of this age group during puberty.

FBT is supported by evidence-based research, aligning with neurobiological findings that suggest eating disorders have multifactorial origins, making it a promising therapeutic approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Adolescents with an eating disorder: an evidence-based approach on the role of parents]. Ambresin, AE., Vust, S., Lier, F., et al.[2015]

Family-Based Interoceptive Exposure (FBT-IE) is a new six-session treatment designed to help adolescents with low-weight eating disorders by targeting and modifying feelings of disgust related to food.

The intervention involves teaching families skills to tolerate distress from visceral sensations and includes practical exercises with meal replacement shakes, aiming to increase food consumption outside of therapy sessions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lessons learned developing and testing family-based interoceptive exposure for adolescents with low-weight eating disorders. Hildebrandt, T., Peyser, D., Sysko, R.[2022]

Family-based treatment (FBT) is the leading recommended intervention for adolescents with eating disorders, but it may not be suitable for all families, particularly if parents are unavailable or unwilling to participate.

Enhanced cognitive behavior therapy (CBT-E) has shown promising results for adolescents aged 11 to 19 and is recommended when FBT is not an option, highlighting the need for further research to compare the effectiveness and acceptability of both treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A conceptual comparison of family-based treatment and enhanced cognitive behavior therapy in the treatment of adolescents with eating disorders. Dalle Grave, R., Eckhardt, S., Calugi, S., et al.[2022]

Family-based treatment (FBT) has shown strong efficacy in treating adolescents with anorexia nervosa (AN), supported by multiple randomized clinical trials, although over half of the cases still struggle with achieving remission.

Early weight gain of approximately 2.5 kg by week four of treatment is a significant predictor of remission by the end of FBT, indicating that monitoring early progress could help tailor interventions for better outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Family-based treatment: Where are we and where should we be going to improve recovery in child and adolescent eating disorders. Lock, J., Le Grange, D.[2022]

A 16-year-old girl with anorexia nervosa showed significant improvement in symptoms and weight gain after six sessions of acceptance-based interoceptive exposure, which helped her tolerate feelings of disgust associated with eating.

The interoceptive exposure technique may enhance the effectiveness of family-based treatment (FBT) for anorexia by equipping patients with skills to manage distress during the refeeding process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Applying the disgust conditioning model of food avoidance: A case study of acceptance-based interoceptive exposure. Plasencia, M., Sysko, R., Fink, K., et al.[2021]

Citations

1. nationaleatingdisorders.org nationaleatingdisorders.org/

NEDA | Eating Disorders Support, Awareness & Recovery Access support, explore resources, join community events, and take a free eating disorders screening—start your recovery journey with NEDA!

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5459462/

Family-based treatment of eating disorders in adolescents Family-based treatment (FBT) has emerged as an effective intervention for adolescents with anorexia nervosa, and preliminary evidence suggests that it may be ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1077722923000172

Enhanced Family-Based Treatment for an Adolescent With ... Highlights. •. Family-based treatment (FBT) is a potentially effective method for treating adolescents with binge-eating disorder ...

4. uchicagomedicine.org uchicagomedicine.org/forefront/news/2010/october/family-based-treatment-found-most-effective-for-anorexia-nervosa-patients

Family based treatment found most effective for anorexia ... An anorexia nervosa treatment strategy that promotes parental involvement in restoring an adolescent to healthy weight and eating habits is more effective

5. jeatdisord.biomedcentral.com jeatdisord.biomedcentral.com/articles/10.1186/s40337-022-00585-y

The five tenets of family-based treatment for adolescent eating ... Family-based treatment (FBT) is the leading treatment for adolescent eating disorders and is based on five tenets, or fundamental assumptions.

6. jamanetwork.com jamanetwork.com/journals/jamapsychiatry/fullarticle/210890

Randomized Clinical Trial Comparing Family-Based ... ContextEvidence-based treatment trials for adolescents with anorexia nervosa are few.ObjectiveTo evaluate the relative efficacy of ...