Comparing two therapies for adolescents with anorexia nervosa
Official title: A Confirmatory Efficacy Study of Interoceptive Exposure for Adolescents With Low Weight Eating Disorders
Run by Icahn School of Medicine at Mount Sinai · NCT05763849 · Data updated 2026-11-12
This study is testing which of two therapies works better for teenagers with anorexia nervosa to help them gain weight and feel better over time.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 12 Years to 18 Years |
| Sex | All |
| Enrollment | 120 (estimated) |
| Sponsor | Icahn School of Medicine at Mount Sinai Academic / other |
| Locations | 1 site (New York, New York) |
| Status | Recruiting |
| Started | March 14, 2023 |
| Main results expected | January 2028 |
| Study ends | January 2028 |
| Registry record updated | June 22, 2026 |
| Trial ID | NCT05763849 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adolescents aged 12-18 who are experiencing clinically significant food intake restrictions and are unable to maintain a healthy body weight.
✕Probably not a fit
Patients with comorbid psychotic or bipolar disorders, active suicidal ideation, or those with current substance dependence may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This project involves a randomized controlled trial that compares two psychological treatments for adolescents aged 12-18 with anorexia nervosa: Exposure-based Family Therapy (IE) and Family Based Therapy (FBT). A total of 120 participants will receive either treatment over 20 outpatient sessions, with assessments conducted at multiple time points over 18 months. The study aims to evaluate the efficacy of these therapies in improving expected body weight and reducing clinical impairment, while also exploring the mechanisms of change involved in the treatment process.
Why it matters
Potential benefit: If successful, this study could provide effective therapeutic options for adolescents struggling with anorexia nervosa, potentially leading to improved weight and psychological outcomes.
How similar studies have gone: Previous studies have shown promise in using exposure-based therapies for eating disorders, suggesting that this approach may be effective, although the specific comparison of these two therapies is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Aged 12-18 * Speak English * Permission from pediatrician or equivalent to receive outpatient care * Clinically significant restriction of food intake by EDA-5 or evidence of persistent food avoidance from patient or guardians * Evidence of the inability to maintain greater than minimally low body weight based on BMI for age percentiles and growth trajectories Exclusion Criteria: * Comorbid psychotic or bipolar disorder * Active suicidal ideation * Current substance dependence * Psychiatric medication initiated or dosage changes \<2 weeks from baseline * Major medical illness (e.g., diabetes mellitus, Crohn's disease, etc.)
Where it's running
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Department of Psychiatry, Eating and Weight Disorders Program
New York, New York, United States Recruiting
Study contacts
- Principal investigator: Thomas Hildebrandt, Psy.D. — Icahn School of Medicine at Mount Sinai
- Study coordinator: Thomas Hildebrandt, Psy.D.
- Email: tom.hildebrandt@mssm.edu
- Phone: (212) 659-8673
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.