Clinical trial NCT06110806: Family-Based Interoceptive Exposure for Avoidant Restrictive Food Intake Disorder
Official title: Family-Based Interoceptive Exposure for Avoidant Restrictive Food Intake Disorder
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Avoidant Restrictive Food Intake Disorder
Keywords: Avoidant Restrictive Food Intake Disorder
Eating Disorder
Eating Disorder Treatment
Family-Based Therapy
Exposure Therapy
Mindfulness
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2023-11-01
Enrollment: 57
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: MBIE-adapted Therapy Suitability and Acceptability Scale to measure Patient MBIE Therapy Tolerability
timeFrame: up to 6 months
Secondary outcomes:
measure: Therapist Adherence to MBIE Therapy
timeFrame: up to 6 months
measure: Dropout Rate
timeFrame: end of treatment, at approximately 6 months
measure: Participant Rating of Acceptability Scale
timeFrame: up to 9 months
measure: Functional Food Hierarchy to Measure Tolerability
timeFrame: up to 6 months
measure: Number of MBIE sessions required to achieve tolerability
timeFrame: up to 6 months
measure: Change in total calories consumed
timeFrame: Baseline and approximately 10 weeks
measure: Change in total calories consumed
timeFrame: Baseline and approximately 6 months
measure: Change in Expected Body Weight Percentage
timeFrame: Baseline and approximately 6 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Department of Psychiatry, Eating and Weight Disorders Program
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Robyn Sysko, PhD
role: PRINCIPAL_INVESTIGATOR
References: