Interoceptive Exposure for Adolescents With Low Weight Eating Disorders

NCT05763849 | Recruiting DMC

• 2 other identifiers: STUDY-22-013231R01MH131655
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Anorexia Nervosa

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (8)

• Change in Autonomous Eating

  Baseline and 6-months

• Change in Autonomous Eating

  Baseline and 18-months

• Change in Food Cue Learning

  Baseline and 6-months

• Change in Food Cue Learning

  Baseline and 18-months

• Change in Eating Disorder Symptoms

  Baseline and 6-months

Study Arms (2)

Interoceptive Exposure Treatment (IE)

EXPERIMENTAL

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

Behavioral: Interoceptive Exposure Treatment (IE)

Family-Based Treatment (FBT)

ACTIVE COMPARATOR

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)

Interventions

Interoceptive Exposure Treatment (IE) BEHAVIORAL

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.

Interoceptive Exposure Treatment (IE)

Family-Based Treatment (FBT) BEHAVIORAL

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.

Family-Based Treatment (FBT)

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Department of Psychiatry, Eating and Weight Disorders Program

New York, New York, 10028, United States

RECRUITING

MeSH Terms

Conditions

Anorexia Nervosa

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders

Study Officials

• Thomas Hildebrandt, Psy.D.

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas Hildebrandt, Psy.D.

CONTACT

(212) 659-8673; tom.hildebrandt@mssm.edu

Jessica Bibeau, MA

CONTACT

212-659-8673; jessica.bibeau@mssm.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: February 28, 2023
• First Posted: March 10, 2023
• Study Start: March 14, 2023
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: June 4, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, ANALYTIC CODE
• Time Frame: Specify Other Time FrameTwice yearly and for each publication
• Access Criteria: Investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose. Any purpose. Specify Other Mechanism Data will be made available through the National Institute of Mental Health Data Archive (NDA)

Locations

US (1)