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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
- Cognitive-Behavioral Therapy for Avoidance Restrictive Food Intake Disorder (CBT-AR) (behavioral)
- Nutrition Counseling for Avoidant/Restrictive Food Intake Disorder (behavioral)
Sponsor: Massachusetts General Hospital · Participants: 70 · Started: 2026-11
Contact the study team
- Jennifer J. Thomas, PhD · Phone: 617-643-6306
Official record on ClinicalTrials.gov — NCT07641205
Locations in the U.S.
| Massachusetts | Eating 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.