Interoceptive Exposure for Adolescents With Low Weight Eating Disorders

This study is comparing two behavioral therapies for adolescents aged 12-18 with Anorexia Nervosa (a serious eating disorder involving low body weight and food restriction). You might be eligible if you are aged 12-18, speak English, and have your pediatrician's permission for outpatient care. The study is testing two approaches: Interoceptive Exposure Treatment (IE), which targets food avoidance, and Family-Based Treatment (FBT), which involves parents helping to increase eating. Researchers want to see how much your body weight changes and if your clinical impairment improves after 6 and 18 months. The study aims to enroll 120 participants, but its current recruitment status is unclear.

Study design
This is a randomized controlled trial comparing two treatments, Interoceptive Exposure Treatment (IE) and Family-Based Treatment (FBT), and plans to enroll 120 participants.
What's involved
You would attend weekly sessions for 20 weeks, with the first session lasting 1.5 hours and subsequent sessions lasting one hour. Assessments will occur at 2, 4, 6, 12, and 18 months after the start of the study.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 12 months after treatment, with assessments at 6 and 18 months from baseline.

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NCT05763849

Interoceptive Exposure for Adolescents With Low Weight Eating Disorders

Recruiting
NAAges 12–18InterventionalTreatment
Icahn School of Medicine at Mount Sinai
~120 participants
Updated 2026-06-22 on ClinicalTrials.gov
What's tested:Interoceptive Exposure Treatment (IE)Family-Based Treatment (FBT)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Expected Body Weight Percentage
Measured over Baseline and 6-months
+3 more outcomes measured
Anorexia Nervosa
1 sites across 1 states
New York1
  • Thomas Hildebrandt, Psy.D. · PRINCIPAL_INVESTIGATOR · Icahn School of Medicine at Mount Sinai

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Eligibility criteria

Inclusion

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

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.)
  • Change in Expected Body Weight PercentageBaseline and 6-months

    Expected body weight percentage will be calculated at baseline and end of treatment (6-months) to calculate difference.

  • Change in Expected Body Weight PercentageBaseline and 18-months

    Expected body weight percentage will be calculated at baseline and 1 year after treatment (18-months) to calculate difference.

  • Change in ImpairmentBaseline and 6-months

    Impairment is measured using the Clinical Impairment Assessment, which is a 16-item self-report measure of impairment from eating disorders. Responses are scored using 0, 1, 2, or 3 and the score is calculated using the sum of all items. Possible scores range between 0 - 48, with higher scores indicating more impairment and lower scores indicating less impairment. Change in impairment will be calculated using the baseline and end of treatment (6-months) scores from CIA.

  • Change in ImpairmentBaseline and 18-months

    Impairment is measured using the Clinical Impairment Assessment, which is a 16-item self-report measure of impairment from eating disorders. Responses are scored using 0, 1, 2, or 3 and the score is calculated using the sum of all items. Possible scores range between 0 - 48, with higher scores indicating more impairment and lower scores indicating less impairment. Change in impairment will be calculated using the baseline and 1 year after treatment (18-months) scores from CIA.