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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 weeks
Treatment ~ Varies
Follow Up ~baseline and 18-months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 18-months for reporting.

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 more

Awards & 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.

Find a Location

Who is running the clinical trial?

National Institute of Mental Health (NIMH)NIH
2,918 Previous Clinical Trials
2,739,796 Total Patients Enrolled
55 Trials studying Eating Disorders
23,567 Patients Enrolled for Eating Disorders
Icahn School of Medicine at Mount SinaiLead Sponsor
904 Previous Clinical Trials
541,701 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

Media Library

Family-Based Treatment (FBT) Clinical Trial Eligibility Overview. Trial Name: NCT05763849 — N/A
Eating Disorders Research Study Groups: Interoceptive Exposure Treatment (IE), Family-Based Treatment (FBT)
Eating Disorders Clinical Trial 2023: Family-Based Treatment (FBT) Highlights & Side Effects. Trial Name: NCT05763849 — N/A
Family-Based Treatment (FBT) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05763849 — N/A
~78 spots leftby Jan 2028
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