Cognitive-behavioral Therapy vs. Nutrition Counseling for Avoidant/Restrictive Food Intake Disorder

Purpose

This study is a randomized controlledlinical trial, assessing the efficacy of cognitive- behavioral therapy (CBT-AR) and nutrition counseling for avoidant/restrictive food intake disorder (ARFID) for children and adolescents (ages 10-18 years).

Condition

  • Avoidant/Restrictive Food Intake Disorder (ARFID)

Eligibility

Eligible Ages
Between 10 Years and 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Males and Females ages 10-18 years old - Current ARFID - Normal TSH or free T4 levels to rule out thyroid disease as cause of symptoms - Negative celiac screening panel indicating no active celiac disease as cause of symptoms - Fluency and literacy in English

Exclusion Criteria

  • BMI < 5th percentile for sex and age - Pregnancy, breastfeeding, or recent initiation/cessation of oral contraceptive pills within 8 weeks of the pre-treatment study visit - Current/history of psychosis - Substance/alcohol use disorder (active within the past month) - Medical instability requiring inpatient care according to the American Psychiatric Association 2023 treatment guidelines for eating disorders - Laboratory abnormalities indicating a need for higher level of care - Complete lack of oral intake (suggesting a need for inpatient care) - Tube feeding (suggesting a need for tube weaning) - Active suicidal/homicidal ideation with intent or plan - Contraindications to MRI - History of major gastrointestinal tract surgery or serious medical condition (e.g., cancer) - Medical history of intellectual disability - Illiteracy

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
CBT-AR
  • Behavioral: Cognitive-Behavioral Therapy for Avoidant/Restrictive Food Intake Disorder (CBT-AR)
    CBT-AR is a four-stage modular treatment for ARFID delivered by a mental health clinician. The four stages include: 1) Psychoeducation and early change; 2) Treatment planning; 3) Addressing maintaining mechanisms; and 4) Relapse prevention. For participants ages 10-15 years, patients/guardians attend the sessions. For patients ages 16 and up, the therapy is individual.
Experimental
Nutrition Counseling
  • Behavioral: Nutrition Counseling for Avoidant/Restrictive Food Intake Disorder
    Nutrition counseling will be provided by skilled registered dietitians at the MGH Translational and Clinical Research Center (TCRC). Sessions focus on the foods necessary for a healthy diet, how to meet nutritional needs, how to incorporate healthy exercise, and support for making these changes. For participants ages 10-15 years, patients/guardians attend the sessions. For patients ages 16 and up, the therapy is individual.

Recruiting Locations

Eating Disorders Clinical and Research Program
Boston, Massachusetts 02139
Contact:
Stefania Yee
617-724-0799
syee5@mgh.harvard.edu

More Details

Status
Recruiting
Sponsor
Massachusetts General Hospital

Study Contact

Jennifer J Thomas, PhD
617-643-6306
jjthomas@mgh.harvard.edu