CBT-AR vs Nutrition Counseling for ARFID in children and teens
Official title: Cognitive and Neural Mechanisms of Cognitive-Behavioral Therapy for Avoidant/Restrictive Food Intake Disorder Part II: Mediation Effects
Run by Massachusetts General Hospital · NCT07641205 · Data updated 2026-11-12
This trial tests whether cognitive-behavioral therapy for ARFID (CBT-AR) or nutrition counseling helps 10- to 18-year-olds with ARFID.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 10 Years to 18 Years |
| Sex | All |
| Enrollment | 70 (estimated) |
| Sponsor | Massachusetts General Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Status | Recruiting |
| Started | November 2026 |
| Main results expected | October 2029 |
| Study ends | October 2029 |
| Registry record updated | November 10, 2026 |
| Trial ID | NCT07641205 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are youths aged 10–18 with ARFID confirmed by structured assessment, fluent in English, and without medical or psychiatric exclusions.
✕Probably not a fit
Patients requiring immediate weight restoration, with recent hormonal contraceptive changes, pregnancy, or psychosis may not benefit from this trial.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized controlled trial compares two interventions for ARFID in youths aged 10–18: cognitive-behavioral therapy tailored for ARFID (CBT-AR) and nutrition counseling. Participants are screened to confirm ARFID and to rule out thyroid or active celiac disease, and must be fluent in English. The primary goal is to determine which approach more effectively improves ARFID-related outcomes over the study period. Exclusion criteria include need for immediate weight restoration, recent hormonal contraceptive changes, pregnancy, and a history of psychosis. The study is led by Massachusetts General Hospital and conducted at the Eating Disorders Clinical and Research Program in Boston, MA.
Why it matters
Potential benefit: If successful, the preferred approach could improve ARFID symptoms and related functioning in youths.
How similar studies have gone: Previous work has explored CBT-AR and nutrition-focused approaches in ARFID, with ongoing evaluation to determine relative efficacy.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Eating Disorders Clinical and Research Program
Boston, Massachusetts, United States Recruiting
Study contacts
- Study coordinator: Jennifer J. Thomas, PhD
- Email: jjthomas@mgh.harvard.edu
- Phone: 617-643-6306
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.