Interoceptive Exposure for Adolescents With Low Weight Eating Disorders

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Confirmatory Efficacy Study of Interoceptive Exposure for Adolescents With Low Weight Eating Disorders

Conditions
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Anorexia Nervosa

Intervention / Treatment
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* Behavioral: Interoceptive Exposure Treatment (IE)
* Behavioral: Family-Based Treatment (FBT)


Participation Criteria
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Eligibility Criteria
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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.)

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This RCT includes a parallel group design including two psychological treatments (Exposure-based Family Therapy vs. Family Based Therapy) for low weight eating disorders with 12 month follow-up.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interoceptive Exposure Treatment (IE)<br>Interoceptive Exposure Therapy (IE) targets food avoidance, food exposure, and body image exposure. | Behavioral: Interoceptive Exposure Treatment (IE)<br>* 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.<br>|
| Active Comparator: Family-Based Treatment (FBT)<br>Family-Based Therapy (FBT) focuses on parent-enforced contingencies, increasing value of eating, and decreasing the value of food avoidance. | Behavioral: Family-Based Treatment (FBT)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Expected Body Weight Percentage | Expected body weight percentage will be calculated at baseline and end of treatment (6-months) to calculate difference. | Baseline and 6-months | 
| Change in Expected Body Weight Percentage | Expected body weight percentage will be calculated at baseline and 1 year after treatment (18-months) to calculate difference. | Baseline and 18-months | 
| Change in Impairment | 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 end of treatment (6-months) scores from CIA. | Baseline and 6-months | 
| Change in Impairment | 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. | Baseline and 18-months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Autonomous Eating | 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 end of treatment (6-months). | Baseline and 6-months | 
| Change in Autonomous Eating | 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). | Baseline and 18-months | 
| Change in Food Cue Learning | 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 end of treatment (6-months). | Baseline and 6-months | 
| Change in Food Cue Learning | 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). | Baseline and 18-months | 
| Change in Eating Disorder Symptoms | 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). | Baseline and 6-months | 
| Change in Eating Disorder Symptoms | 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). | Baseline and 18-months | 
| Change in Nonjudgmental Body Awareness | 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 (6-months). | Baseline and 6-months | 
| Change in Nonjudgmental Body Awareness | 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). | Baseline and 18-months |