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

Recruiting

Cognitive and Neural Mechanisms of Cognitive-Behavioral Therapy for Avoidant/Restrictive Food Intake Disorder Part II: Mediation Effects

Who can join

Ages 10 to 18 · All sexes

Full eligibility criteria
Inclusion Criteria:

* Males and Females ages 10-18 years old
* Current ARFID assessed via Feeding and Eating Disorders Model from the "Enhanced" Structured Interview for DSM-5 (SCID-5)
* Normal TSH or free T4 levels to rule out thyroid disease as cause of symptoms inclusionary for randomization
* Negative celiac screening panel indicating no active celiac disease as cause of symptoms inclusionary for randomization
* Fluency and literacy in English

Exclusion Criteria:

* Patient requires weight restoration treatment (e.g., \< 5th percentile of BMI, height, or weight for sex and age; patient has fallen off individual growth trajectory; patient's medical providers have recommended weight restoration) such that 15 sessions of CBT-AR is not appropriate
* Pregnancy, breastfeeding, or recent initiation/cessation of estrogen-containing systemic contraceptives within 8 weeks of the pre-treatment study visit (as these could impact neuroimaging)
* Current/history of psychosis via Mini-International Neuropsychiatric Interview child/adolescent version (MINI KID)
* Substance/alcohol use disorder (active within the past month) via MINI KID
* Medical instability requiring inpatient care according to the American Psychiatric Association 2006 treatment guidelines for eating disorders
* Laboratory abnormalities indicating a need for higher level of care (assessed by complete blood count and comprehensive metabolic panel) exclusionary for randomization
* Complete lack of oral intake (suggesting a need for inpatient care)
* Tube feeding (suggesting a need for tube weaning) Significant weight/shape concern-motivating eating pathology as evidenced by a global Eating Disorders Examination Questionnaire (EDE-Q) score greater than 4
* Active suicidal ideation with intent or plan via the 5-item Self-Injurious Thoughts and Behaviors Interview-Revised (SITBI-R)
* Contraindications to MRI
* History of major gastrointestinal tract surgery or serious medical condition (e.g., cancer)
* Medical history of intellectual disability
* Illiteracy

About the study

This study is a randomized controlled 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).

What is being tested

Sponsor: Massachusetts General Hospital · Participants: 70 · Started: 2026-11

Contact the study team

Official record on ClinicalTrials.gov — NCT07641205

Locations in the U.S.

MassachusettsEating Disorders Clinical and Research Program, Boston

Conditions

From ClinicalTrials.gov, data retrieved Nov 15, 2026. Each study sets its own eligibility; the study team decides who can join.