Interoceptive Exposure for Adolescents With Low Weight Eating Disorders
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Interoceptive Exposure Treatment (IE), Family-Based Treatment (FBT).
- Who it may be relevant to
- Registry conditions: Anorexia Nervosa. Basic parameters: 12 years — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Confirmatory Efficacy Study of Interoceptive Exposure for Adolescents With Low Weight Eating Disorders
Overview
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.
Interventions
- Behavioral 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 thr - Behavioral 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.
Primary outcome measures
- 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]
Secondary outcome measures (8)
- Change in Autonomous Eating [Time frame: Baseline and 6-months]
- Change in Autonomous Eating [Time frame: Baseline and 18-months]
- Change in Food Cue Learning [Time frame: Baseline and 6-months]
- Change in Food Cue Learning [Time frame: Baseline and 18-months]
- Change in Eating Disorder Symptoms [Time frame: Baseline and 6-months]
- Change in Eating Disorder Symptoms [Time frame: Baseline and 18-months]
- Change in Nonjudgmental Body Awareness [Time frame: Baseline and 6-months]
- Change in Nonjudgmental Body Awareness [Time frame: Baseline and 18-months]
Eligibility 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.)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Department of Psychiatry, Eating and Weight Disorders Program — New York
Identifiers
NCT: NCT05763849 · STUDY-22-01323 · 1R01MH131655