Family-Based Interoceptive Exposure for Avoidant Restrictive Food Intake Disorder

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.

Study Overview

• Status: Terminated
• Conditions: Avoidant Restrictive Food Intake Disorder
• Intervention / Treatment: Behavioral: MBIE

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.

• Study Type: Interventional
• Enrollment (Actual): 57
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10029
      • Department of Psychiatry, Eating and Weight Disorders Program

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mindfulness-based interoceptive exposure (MBIE); Outpatient therapy for individuals with ARFID using mindfulness and exposures in a family-based therapy approach.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MBIE-adapted Therapy Suitability and Acceptability Scale to measure Patient MBIE Therapy Tolerability	An MBIE-adapted Therapy Suitability and Acceptability Scale will average specific items from patient's view on match of therapy to the problem, responsiveness of intervention to different treatment challenges, degree of unexpected discomfort related to treatment, interest in using therapy experiences beyond the therapy session. This scale includes 10-20 items, depending on the session content, and is measured using a Likert scale from 1-7. Scores are calculated using a sum of all items, with a possible range of scores of 10 to 140. Higher scores indicate greater suitability of the treatment for the child and expectancy of success with the intervention.	up to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Therapist Adherence to MBIE Therapy	Adherence of the MBIE intervention will be measured with ratings of therapy tapes of 20 sessions. Adherence will be calculated using a dichotomous scale (yes/no) of items rating the extent of use of treatment elements and the quality of delivery of the intervention. As the number of treatment elements vary, and some items are reverse coded, the minimum, maximum, and scaling are not utilized. Per item adherence can range from 0 to 100%.	up to 6 months
Dropout Rate	Retention will be measured using rates of dropout between baseline and session 20 (end of treatment, at approximately 6 months).	end of treatment, at approximately 6 months
Participant Rating of Acceptability Scale	Acceptability of data collection and assessment procedures will be measured using participant ratings of acceptability for total time and frequency on an investigator-derived scale. This measurement includes items assessing the (1) tolerability and (2) ease of completing laboratory, behavior, and self-report tasks using a 15 mm visual analog scale. Scores are calculated by summing all ratings (in mm), ranging from 0-20. Higher scores indicate greater acceptability of study assessments.	up to 9 months
Functional Food Hierarchy to Measure Tolerability	The number of MBIE sessions required to achieve a clinically meaningful outcome and acceptable tolerability using a Functional Food Hierarchy. This measurement rates a minimum of 11 food items on a scale of 0-10 at 10 levels of the hierarchy (subjective units of distress). Scores range from 0-100 with higher scores indicating lower avoidance/increased consumption.	up to 6 months
Number of MBIE sessions required to achieve tolerability	The number of MBIE sessions required to achieve a clinically meaningful outcome (consuming food rated as70 or higher on the Food Avoidance Scale). The Food Avoidance Scale is investigator-derived and includes 1 item rated on a scale of 0-100 with higher scores indicating consumption of more challenging/avoided foods.	up to 6 months
Change in total calories consumed	Autonomous eating will be measured in total calories consumed during a single-item meal. Total calories consumed will be calculated between baseline and session 10 of treatment	Baseline and approximately 10 weeks
Change in total calories consumed	Autonomous eating will be measured in total calories consumed during a single-item meal. Total calories consumed will be calculated between baseline and end of treatment (session 20).	Baseline and approximately 6 months
Change in Expected Body Weight Percentage	Expected body weight percentage will be calculated for age and sex to evaluate physical status at baseline and end of treatment (session 20) to evaluate any changes during treatment.	Baseline and approximately 6 months

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Investigators: Principal Investigator: Robyn Sysko, PhD, Icahn School of Medicine at Mount Sinai

Study record dates

Study Major Dates

• Study Start (Actual): October 17, 2023
• Primary Completion (Actual): July 8, 2024
• Study Completion (Actual): July 8, 2024

Study Registration Dates

• First Submitted: October 26, 2023
• First Submitted That Met QC Criteria: October 26, 2023
• First Posted (Actual): November 1, 2023

Study Record Updates

• Last Update Posted (Actual): February 17, 2026
• Last Update Submitted That Met QC Criteria: February 13, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Mindfulness; Eating Disorder; Avoidant Restrictive Food Intake Disorder; Exposure Therapy; Family-Based Therapy; Eating Disorder Treatment
• Additional Relevant MeSH Terms: Mental Disorders; Signs and Symptoms, Digestive; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Avoidant Restrictive Food Intake Disorder; Feeding and Eating Disorders
• Other Study ID Numbers: STUDY-23-00440

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All of the individual participant data collected during the trial, after deidentification.
• IPD Sharing Time Frame: Twice yearly

IPD Sharing Access Criteria

Investigators whose proposed use of the data has been approved by an independent review committee ('learned intermediary') identified for this purpose.

Any purpose. Specify Other Mechanism Data will be made available through the National Institute of Mental Health Data Archive (NDA)

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No