Cognitive-behavioral Therapy vs. Nutrition Counseling for Avoidant/Restrictive Food Intake Disorder Part II
Starting soon · Not applicable
Conditions studied: Avoidant/Restrictive Food Intake Disorder (ARFID)
In brief
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).
Key facts
- Study ID
- NCT07641205
- Run by
- Massachusetts General Hospital
- People needed
- 70
- Starts
- 2026-07-01
- Expected to finish
- 2029-10-01
- Last updated by the study team
- 2026-06-15
Who can join
Age: 10 and older, up to 18. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 is running
- Eating Disorders Clinical and Research Program — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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