Interoceptive Exposure for Adolescents With Low Weight Eating Disorders

Anorexia Nervosa Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05763849
• Other study ID #: STUDY-22-01323
• Secondary ID: 1R01MH131655
• Status: Recruiting
• Phase: N/A
• Start date: March 14, 2023
• Est. completion date: January 2028

Study information

• Verified date: June 2024
• Source: Icahn School of Medicine at Mount Sinai
• Contact: Thomas Hildebrandt, Psy.D.
• Phone: (212) 659-8673
• Email: tom.hildebrandt[@]mssm.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: January 2028
• Est. primary completion date: January 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 18 Years

Eligibility

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.)

Related Conditions & MeSH terms

• Anorexia
• Anorexia Nervosa
• Feeding and Eating Disorders

Intervention

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 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.
• 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. 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.

Locations

Country	Name	City	State
United States	Department of Psychiatry, Eating and Weight Disorders Program	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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