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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Maximum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
New York
Department of Psychiatry, Eating and Weight Disorders Program
RECRUITING
New York
Contact Information
Primary
Thomas Hildebrandt, Psy.D.
tom.hildebrandt@mssm.edu
(212) 659-8673
Backup
Jessica Bibeau, MA
jessica.bibeau@mssm.edu
212-659-8673
Time Frame
Start Date: 2023-03-14
Estimated Completion Date: 2028-01
Participants
Target number of participants: 120
Treatments
Experimental: Interoceptive Exposure Treatment (IE)
Interoceptive Exposure Therapy (IE) targets food avoidance, food exposure, and body image exposure.
Active_comparator: Family-Based Treatment (FBT)
Family-Based Therapy (FBT) focuses on parent-enforced contingencies, increasing value of eating, and decreasing the value of food avoidance.
Related Therapeutic Areas
Sponsors
Collaborators: National Institute of Mental Health (NIMH)
Leads: Icahn School of Medicine at Mount Sinai

This content was sourced from clinicaltrials.gov