Interoceptive Exposure for Adolescents With Low Weight Eating Disorders

Not Applicable

Recruiting

• Conditions: Anorexia Nervosa
• Interventions: Behavioral: Interoceptive Exposure Treatment (IE); Behavioral: Family-Based Treatment (FBT)

• Registration Number: NCT05763849
• Lead Sponsor: Icahn School of Medicine at Mount Sinai

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.

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.

Study Timeline

• Study First Submitted: 2023-02-28
• Study First Submitted QC: 2023-02-28
• Study First Posted: 2023-03-10
• Study Start: 2023-03-14
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-12
• Last Update Posted: 2024-06-13
• Primary Completion: 2028-01
• Study Completion: 2028-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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

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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.)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Interoceptive Exposure Treatment (IE)	Interoceptive Exposure Treatment (IE)	Interoceptive Exposure Therapy (IE) targets food avoidance, food exposure, and body image exposure.
Family-Based Treatment (FBT)	Family-Based Treatment (FBT)	Family-Based Therapy (FBT) focuses on parent-enforced contingencies, increasing value of eating, and decreasing the value of food avoidance.

Primary Outcome Measures

Name	Time	Method
Change in Impairment	Baseline 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.
Change in Expected Body Weight Percentage	Baseline and 18-months	Expected body weight percentage will be calculated at baseline and 1 year after treatment (18-months) to calculate difference.

Secondary Outcome Measures

Name	Time	Method
Change in Autonomous Eating	Baseline and 18-months	Autonomous eating will be measured in total calories consumed during a single-item meal. Change in total calories consumed will be calculated between baseline and 1 year after treatment (18-months).
Change in Nonjudgmental Body Awareness	Baseline and 18-months	Body awareness Questionnaire (BAQ) is a self-report measure assessing awareness of body sensitivity and changes using 18 items on a score range of 18-126. Higher scores indicate more awareness of body regulation. Scores will be calculated between baseline and end of treatment (18-months).
Change in Food Cue Learning	Baseline and 18-months	Food cue learning is a task completed on a computer that tests associations between food and level of disgust. Pictures of food are shown including fresh and rotten versions of each and participants then rate on a scale from yucky to yummy for each. These ratings produce an extinction rate. There is no set range for scoring, however lower rates indicate more impairment and higher rates indicate less impairment. Extinction rate will be calculated between baseline and 1 year after treatment (18-months).
Change in Eating Disorder Symptoms	Baseline and 18-months	Youth Eating Disorder Questionnaire (Y-EDE-Q) is a self-report measure assessing psychopathology of eating disorders in youth using 39 items. Global scores range from 0 to 6 with higher scores indicating symptoms of higher severity. Scores will be calculated between baseline and end of treatment (6-months).

Trial Locations

Locations (1)

Department of Psychiatry, Eating and Weight Disorders Program; 🇺🇸 New York, New York, United States