Family-Based Interoceptive Exposure for Avoidant Restrictive Food Intake Disorder

NCT06110806 | Terminated DMC

• 1 other identifier: STUDY-23-00440
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

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.

Conditions

Avoidant Restrictive Food Intake Disorder

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Therapist Adherence to MBIE Therapy

  up to 6 months

• Dropout Rate

  end of treatment, at approximately 6 months

• Participant Rating of Acceptability Scale

  up to 9 months

• Functional Food Hierarchy to Measure Tolerability

  up to 6 months

• Number of MBIE sessions required to achieve tolerability

  up to 6 months

Study Arms (1)

Mindfulness-based interoceptive exposure (MBIE)

EXPERIMENTAL

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

Behavioral: MBIE

Interventions

MBIE 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.

Mindfulness-based interoceptive exposure (MBIE)

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Department of Psychiatry, Eating and Weight Disorders Program

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Avoidant Restrictive Food Intake Disorder; Feeding and Eating Disorders

Condition Hierarchy (Ancestors)

Mental Disorders; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Robyn Sysko, PhD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: This single-site clinical trial includes non-randomizing, dose-optimizing (20 sessions) clinical trial design to examine feasibility and appropriate duration of treatment. A final assessment will take place 3-months post intervention.

Study Record Dates

• First Submitted: October 26, 2023
• First Posted: November 1, 2023
• Study Start: October 17, 2023
• Primary Completion: July 8, 2024
• Study Completion: July 8, 2024
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Twice yearly
• 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)

Locations

US (1)