Interoceptive Exposure for Eating Disorders

Overseen by Thomas Hildebrandt, Psy.D.

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Icahn School of Medicine at Mount Sinai

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

No Placebo Group

Trial Summary

What is the purpose of this trial?

This project includes a parallel group randomized controlled trial comparing two psychological treatments: 1) Exposure-based Family Therapy (IE) vs. 2) Family Based Therapy (FBT) for low weight eating disorders with 12 month follow-up. Primary outcomes are expected body weight and clinical impairment. Three mechanisms of change (Autonomous Eating, Non-Judgmental Body Awareness, and Extinction Learning) will be examined in a process mediation models of change.

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.

What data supports the effectiveness of the treatment Interoceptive Exposure for Eating Disorders?

Family-Based Treatment (FBT) is a well-supported approach for adolescents with eating disorders, particularly anorexia nervosa, and has been shown to be effective in improving outcomes. Interoceptive Exposure, when combined with FBT, is being explored as a promising method to enhance treatment for low-weight eating disorders. ^{1 2 3 4 5}

Is Family-Based Interoceptive Exposure safe for treating eating disorders in adolescents?

Family-Based Interoceptive Exposure (FBT-IE) for adolescents with eating disorders is based on Family-Based Treatment (FBT), which is considered safe and is a leading treatment for conditions like anorexia nervosa. While specific safety data for FBT-IE is limited, FBT has been widely used and is generally regarded as safe for adolescents. ^{1 2 3 5 6}

How is Interoceptive Exposure Treatment (IE) for eating disorders different from other treatments?

Interoceptive Exposure Treatment (IE) is unique because it combines family-based therapy with exposure techniques to help adolescents with eating disorders confront and manage their physical sensations and emotions, which is not typically a focus in standard family-based treatments. ^{2 3 5 6 7}

Research Team

Thomas Hildebrandt, Psy.D.

Principal Investigator

Icahn School of Medicine at Mount Sinai

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

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

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.

Participant Groups

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 Canada for the following indications:

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+

Findings from Research

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 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]

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]

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 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]

References

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

Enhanced cognitive-behavior therapy and family-based treatment for adolescents with an eating disorder: a non-randomized effectiveness trial. [2022]

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

Lessons learned developing and testing family-based interoceptive exposure for adolescents with low-weight eating disorders. [2022]

3. England 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. [2022]

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

Applying the disgust conditioning model of food avoidance: A case study of acceptance-based interoceptive exposure. [2021]

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

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

6. Switzerland pubmed.ncbi.nlm.nih.gov

[Adolescents with an eating disorder: an evidence-based approach on the role of parents]. [2015]

7. United States 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. [2022]