RECRUITING

Interoceptive Exposure for Adolescents With Low Weight Eating Disorders

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-03-14
Study Completion:2028-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05763849

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:12 Years to 18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Aged 12-18
  2. * Speak English
  3. * Permission from pediatrician or equivalent to receive outpatient care
  4. * Clinically significant restriction of food intake by EDA-5 or evidence of persistent food avoidance from patient or guardians
  5. * Evidence of the inability to maintain greater than minimally low body weight based on BMI for age percentiles and growth trajectories
  1. * Comorbid psychotic or bipolar disorder
  2. * Active suicidal ideation
  3. * Current substance dependence
  4. * Psychiatric medication initiated or dosage changes \<2 weeks from baseline
  5. * Major medical illness (e.g., diabetes mellitus, Crohn's disease, etc.)

Contacts and Locations

Study Contact

Thomas Hildebrandt, Psy.D.
CONTACT
(212) 659-8673
tom.hildebrandt@mssm.edu
Jessica Bibeau, MA
CONTACT
212-659-8673
jessica.bibeau@mssm.edu

Principal Investigator

Thomas Hildebrandt, Psy.D.
PRINCIPAL_INVESTIGATOR
Icahn School of Medicine at Mount Sinai

Study Locations (Sites)

Department of Psychiatry, Eating and Weight Disorders Program
New York, New York, 10028
United States

Collaborators and Investigators

Sponsor: Icahn School of Medicine at Mount Sinai

  • Thomas Hildebrandt, Psy.D., PRINCIPAL_INVESTIGATOR, Icahn School of Medicine at Mount Sinai

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-03-14
Study Completion Date2028-01

Study Record Updates

Study Start Date2023-03-14
Study Completion Date2028-01

Terms related to this study

Additional Relevant MeSH Terms

  • Anorexia Nervosa