Family-Based Interoceptive Exposure for Avoidant Restrictive Food Intake Disorder

Icahn School of Medicine at Mount Sinai12 enrolled

Overview

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.

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Avoidant Restrictive Food Intake Disorder

Eligibility

Sex: ALLMin age: 12 YearsMax age: 18 Years

Medical Language ↔ Plain English

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).

Outcomes

Primary Outcomes

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.

Time frame: up to 6 months

Secondary Outcomes

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%.

Time frame: Session 20, at week 20

Number of Participants Who Withdrew

Retention will be measured using rates of dropout between baseline and session 20 (end of treatment, at approximately 6 months). Number of participants who withdrew prior to termination of study.

Time frame: Session 20, at week 20

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. Questions are scored from 0-15 and then all scores are summed for an acceptability score. Ranges include 0-120 at baseline, 0 to 30 at Session 5, 0-120 at Session 10, and 0-120 at Session 20. Higher scores indicate greater acceptability of study assessments.

Time frame: baseline and session 5 (at week 5), session 10 (at week 10), session 20 (at week 20)

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.

Time frame: 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.

Time frame: 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, and between baseline and session 20 of treatment.

Time frame: Baseline and approximately 10 weeks and 20 weeks

Change in Body Mass Index (BMI) Percentile

Change in BMI percentile at baseline and end of treatment (session 20) to evaluate any changes during treatment.

Time frame: Baseline and session 20 (at week 20)

Family-Based Interoceptive Exposure for Avoidant Restrictive Food Intake Disorder

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes