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Interoceptive Exposure for Eating Disorders
N/A
Recruiting
Led By Thomas Hildebrandt, PsyD
Research Sponsored by Icahn School of Medicine at Mount Sinai
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 18-months
Awards & highlights
No Placebo-Only Group
Summary
This trial will compare two psychological treatments for eating disorders to see which works best for improving body weight & clinical impairment. It'll also study how these treatments work.
Who is the study for?
This trial is for English-speaking adolescents aged 12-18 with low weight eating disorders like anorexia. They must have a doctor's permission for outpatient care, show significant food intake restriction or avoidance, and be unable to maintain a healthy body weight. Those with substance dependence, bipolar/psychotic disorders, recent psychiatric medication changes, major medical illnesses, or active suicidal thoughts cannot join.
What is being tested?
The study compares two psychological treatments: Interoceptive Exposure-based Family Therapy (IE) and standard Family-Based Treatment (FBT). It aims to see which treatment better helps teens reach expected body weight without clinical impairment over a year. The study also looks at how these therapies work by focusing on autonomous eating habits, non-judgmental body awareness, and learning to overcome fear responses related to eating.
What are the potential side effects?
Since the interventions are psychological treatments rather than medications, typical drug side effects are not expected. However, participants may experience emotional discomfort or increased anxiety as they confront fears related to food intake and body image during therapy sessions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and 18-months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 18-months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Expected Body Weight Percentage
Change in Impairment
Secondary study objectives
Change in Autonomous Eating
Change in Eating Disorder Symptoms
Change in Food Cue Learning
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Interoceptive Exposure Treatment (IE)Experimental Treatment1 Intervention
Interoceptive Exposure Therapy (IE) targets food avoidance, food exposure, and body image exposure.
Group II: Family-Based Treatment (FBT)Active Control1 Intervention
Family-Based Therapy (FBT) focuses on parent-enforced contingencies, increasing value of eating, and decreasing the value of food avoidance.
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Who is running the clinical trial?
National Institute of Mental Health (NIMH)NIH
2,936 Previous Clinical Trials
2,741,922 Total Patients Enrolled
55 Trials studying Eating Disorders
23,567 Patients Enrolled for Eating Disorders
Icahn School of Medicine at Mount SinaiLead Sponsor
914 Previous Clinical Trials
572,781 Total Patients Enrolled
1 Trials studying Eating Disorders
59 Patients Enrolled for Eating Disorders
Thomas Hildebrandt, PsyDPrincipal Investigatortom.hildebrandt@mssm.edu
1 Previous Clinical Trials
600 Total Patients Enrolled
Thomas Hildebrandt, Psy.D.Principal InvestigatorIcahn School of Medicine at Mount Sinai
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't started or changed any psychiatric meds in the last 2 weeks.I have a major medical condition like diabetes or Crohn's disease.I have a significant problem with eating or avoiding food.I am currently having thoughts about harming myself.I am between 12 and 18 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Interoceptive Exposure Treatment (IE)
- Group 2: Family-Based Treatment (FBT)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.