Status:
SUSPENDED
Family-Based Interoceptive Exposure for Avoidant Restrictive Food Intake Disorder
Lead Sponsor:
Icahn School of Medicine at Mount Sinai
Conditions:
Avoidant Restrictive Food Intake Disorder
Eligibility:
All Genders
12-18 years
Phase:
NA
Brief Summary
This project aims to establish the feasibility and acceptability of a comprehensive mind and body intervention; specifically a mindfulness-based interoceptive exposure (MBIE) for families of youth dia...
Detailed Description
A total of 57 individuals with ARFID ages 12-18 will be enrolled to outpatient mindfulness-based interoceptive exposure (MBIE). MBIE targets increasing psychological flexibility and acceptance by decr...
Eligibility Criteria
Inclusion
- Patient:
- Aged 12-18
- Speaks English
- Permission from pediatrician or equivalent to receive outpatient care, including that the patient does not meet criteria for hospitalization based on the American Psychiatric Association guidelines
- Diagnosis of Avoidant Restrictive Food Intake Disorder, as assessed by the EDA-5
- Parent:
- Has a child aged 12-18 with a diagnosis of ARFID
- Speaks English
Exclusion
- Comorbid psychotic or bipolar disorder
- Psychiatric medication initiated or with a dosage change in the two weeks prior to baseline testing
- Active suicidal ideation
- Major medical condition (e.g., diabetes mellitus, pregnancy)
- Current substance dependence, as evidenced by tolerance and withdrawal
- Evidence of anatomical findings by imaging (e.g., swallow study) that would prevent safe consumption of the shake or those with a percutaneous endoscopic gastrostomy or other similar feeding tube insertion
- Children with visual or physical limitations that would preclude watching a screen and using a finger to respond with mouse clicks (e.g., blindness, epilepsy if exposure to flashing lights at certain intensities or to certain visual patterns can trigger seizures).
Key Trial Info
Start Date :
October 17 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2026
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT06110806
Start Date
October 17 2023
End Date
May 1 2026
Last Update
November 6 2025
Active Locations (1)
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1
Department of Psychiatry, Eating and Weight Disorders Program
New York, New York, United States, 10029