Family-Based Interoceptive Exposure for Avoidant Restrictive Food Intake Disorder

NCT ID: NCT06110806

Last Updated: 2025-11-06

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: NA
• Total Enrollment: 57 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-17
• Study Completion Date: 2026-05-31

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 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.

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 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.

Conditions

Avoidant Restrictive Food Intake Disorder

Keywords

Avoidant Restrictive Food Intake Disorder; Eating Disorder; Eating Disorder Treatment; Family-Based Therapy; Exposure Therapy; Mindfulness

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Mindfulness-based interoceptive exposure (MBIE)

Outpatient therapy for individuals with ARFID using mindfulness and exposures in a family-based therapy approach.

Group Type: EXPERIMENTAL

MBIE

Intervention Type: BEHAVIORAL

MBIE administered over 20 sessions, 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.

Interventions

MBIE

MBIE administered over 20 sessions, 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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).

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role: lead

Responsible Party

Robyn Sysko

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Robyn Sysko, PhD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

Department of Psychiatry, Eating and Weight Disorders Program

New York, New York, United States

Countries

United States

Other Identifiers

STUDY-23-00440

Identifier Type: -

Identifier Source: org_study_id