Clinical trial NCT05763849: Interoceptive Exposure for Adolescents With Low Weight Eating Disorders
Official title: A Confirmatory Efficacy Study of Interoceptive Exposure for Adolescents With Low Weight Eating Disorders
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anorexia Nervosa
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2023-03-10
Enrollment: 120
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Detailed description: A total of 120 individuals with Anorexia Nervosa ages 12-18 will be enrolled to either 20 sessions of outpatient Exposure-based Family Therapy (IE) or Family Based Therapy (FBT). The aims of the study are to test the comparative efficacy and primary mechanisms of change after 6 months of treatment and at one year post-treatment and to explore the mediators and moderators of the primary outcomes at these endpoints. All recruitment and study procedures will take place through the Center of Excellence in Eating and Weight Disorders at the Icahn School of Medicine at Mount Sinai. Assessments will take place at 2-, 4-, 6-, 12-, and 18-months following baseline.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.)

Primary outcomes:
measure: Change in Expected Body Weight Percentage
timeFrame: Baseline and 6-months
measure: Change in Expected Body Weight Percentage
timeFrame: Baseline and 18-months
measure: Change in Impairment
timeFrame: Baseline and 6-months
measure: Change in Impairment
timeFrame: Baseline and 18-months
Secondary outcomes:
measure: Change in Autonomous Eating
timeFrame: Baseline and 6-months
measure: Change in Autonomous Eating
timeFrame: Baseline and 18-months
measure: Change in Food Cue Learning
timeFrame: Baseline and 6-months
measure: Change in Food Cue Learning
timeFrame: Baseline and 18-months
measure: Change in Eating Disorder Symptoms
timeFrame: Baseline and 6-months
measure: Change in Eating Disorder Symptoms
timeFrame: Baseline and 18-months
measure: Change in Nonjudgmental Body Awareness
timeFrame: Baseline and 6-months
measure: Change in Nonjudgmental Body Awareness
timeFrame: Baseline and 18-months
Other outcomes:
Locations:
city: New York
country: United States
facility: Department of Psychiatry, Eating and Weight Disorders Program
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Thomas Hildebrandt, Psy.D.
role: PRINCIPAL_INVESTIGATOR
References: