Recruiting

Interoceptive Exposure

Sponsor:

Icahn School of Medicine at Mount Sinai

Code:

NCT05763849

Conditions

Anorexia Nervosa

Eligibility Criteria

Sex: All

Age: 12 - 18

Healthy Volunteers: Not accepted

Interventions

Interoceptive Exposure Treatment (IE)

Family-Based Treatment (FBT)

Study Details

Brief summary:

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.

Conditions

Anorexia Nervosa

Study ID

NCT05763849

Start date

Mar 14, 2023

Status verified date

Jun, 2026

Completion date

Jan, 2028

Anticipated

Primary completion date

Jan, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 18

Healthy Volunteers: Not accepted

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.)

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Interoceptive Exposure Treatment (IE)

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

active comparator: Family-Based Treatment (FBT)

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

Interventions

Interoceptive Exposure Treatment (IE)

Interoceptive Exposure Therapy (IE) targets food avoidance in Anorexia Nervosa. Each session the therapist weighs the patient, checks-in, and reviews weekly homework. Sessions occur weekly for 20 weeks, with the first session lasting 1.5 hours and the remaining sessions one hour. Early sessions include using exposure to foods and counterconditioning to pair a positive stimulus with a food that would typically produce food avoidance. Parents are trained to model this at home. Sessions mid-way through address the use of non-judgmental description of appearance during mirror exposure. Sessions at the end of the 20 weeks are focused on recognizing change, planning for future obstacles, and developing a relapse prevention plan to continue practicing distress tolerance, counter-conditioning, and food/body exposure.

Family-Based Treatment (FBT)

Family-Based Therapy (FBT) includes parent-enforced contingencies to increase value of eating and decrease the value of food avoidance. Each session the therapist weighs the patient, checks-in, and reviews weekly homework. Sessions occur weekly for 20 weeks, with the first session lasting 1.5 hours and the remaining sessions one hour. Sessions consist of checking in with the patient, discussion of the week's implementation of refeeding, and helping parents separate the illness from their child. In session 2, a family meal provides the therapist with an opportunity for direct observation of the familial interaction patterns around eating. The therapist makes careful and persistent requests for united parental action toward re-feeding and/or regulating eating habits, the primary concern at this point of the treatment, and the therapist tries to create and reinforce a strong parental alliance around efforts at feeding the child.

Primary outcome measure

  • Change in Expected Body Weight Percentage [ Time Frame: Baseline and 6-months ]
  • Change in Expected Body Weight Percentage [ Time Frame: Baseline and 18-months ]
  • Change in Impairment [ Time Frame: Baseline and 6-months ]
  • Change in Impairment [ Time Frame: Baseline and 18-months ]

Central Contacts and Locations

Central contacts

Thomas Hildebrandt, Psy.D.

(212) 659-8673tom.hildebrandt@mssm.edu

Jessica Bibeau, MA

212-659-8673jessica.bibeau@mssm.edu

Locations

Department of Psychiatry, Eating and Weight Disorders Program

Recruiting

New York, New York, United States, 10028

Contacts

Jessica Bibeau, MA

212-659-8673jessica.bibeau@mssm.edu

Principal Investigator:

Thomas Hildebrandt, Psy.D

More Information

Sponsor

Icahn School of Medicine at Mount Sinai

Last update posted

Jun 22, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Icahn School of Medicine at Mount Sinai on 2026-06-22.