Family-Based Interoceptive Exposure for Avoidant Restrictive Food Intake Disorder

Mount Sinai Health System

Status

Suspended

Conditions

Avoidant Restrictive Food Intake Disorder

Treatments

Behavioral: MBIE

Study type

Interventional

Funder types

Other

Identifiers

NCT06110806

STUDY-23-00440

Details and patient eligibility

About

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 diagnosed with avoidant/restrictive food intake disorder (ARFID). This project will: (1) explore the feasibility of recruitment, retention, and data collection procedures with youth with ARFID at end of treatment, (2) establish the acceptability and adherence of the MBIE intervention, and (3) evaluate the number of MBIE sessions required to observe changes in the number of foods avoided and mindfulness skills.

Full 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 decreasing avoidance and attempts to control distressing or undesired internal experiences, and includes psychoeducation, targeted mindfulness practice, in vivo exposures, and counter-conditioning. MBIE will be administered in 20 sessions. Interview, self-report, anthropometrics, laboratory feeding, and behavioral task data will be used to characterize the sample to their response to treatment over time. Follow-up assessments will be completed at session 5, 10, 15, and 20. The final assessment will take place 3 months after treatment ends. Total participation will last 9 months.

Enrollment

57 estimated patients

Sex

All

Ages

12 to 18 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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).