Back to Trials
NCT05763849NARecruiting

Interoceptive Exposure for Adolescents With Low Weight Eating Disorders

Icahn School of Medicine at Mount Sinai

Start Date

3/14/2023

Completion Date

1/1/2028

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.

Detailed Description

A total of 120 individuals with Anorexia Nervosa ages 12-18 will be enrolled to either 20 sessions of outpatient Exposure-based Family Therapy (IE) or Family Based Therapy (FBT). The aims of the study are to test the comparative efficacy and primary mechanisms of change after 6 months of treatment and at one year post-treatment and to explore the mediators and moderators of the primary outcomes at these endpoints. All recruitment and study procedures will take place through the Center of Excellence in Eating and Weight Disorders at the Icahn School of Medicine at Mount Sinai. Assessments will take place at 2-, 4-, 6-, 12-, and 18-months following baseline.

Eligibility Criteria

Age Range: 12 years to 18 years

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.)

Interventions

BEHAVIORAL

Interoceptive Exposure Treatment (IE)

BEHAVIORAL

Family-Based Treatment (FBT)

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Anorexia Nervosa

Locations

Department of Psychiatry, Eating and Weight Disorders Program

New York, New York 10028

United States