Interoceptive Exposure for Adolescents With Low Weight Eating Disorders

Mount Sinai Health System

Status: Enrolling

Conditions: Anorexia Nervosa

Treatments: Behavioral: Family-Based Treatment (FBT); Behavioral: Interoceptive Exposure Treatment (IE)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05763849

STUDY-22-01323

1R01MH131655 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 12 to 18 years old

Volunteers: No Healthy Volunteers

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.)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Interoceptive Exposure Treatment (IE)

Experimental group

Description:

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

Treatment:

Behavioral: Interoceptive Exposure Treatment (IE)

Family-Based Treatment (FBT)

Active Comparator group

Description:

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

Treatment:

Behavioral: Family-Based Treatment (FBT)