Cognitive-behavioral Therapy vs. Nutrition Counseling for Avoidant/Restrictive Food Intake Disorder
Completed · Not applicable
Conditions studied: Avoidant/Restrictive Food Intake Disorder (ARFID)
In brief
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).
Key facts
- Study ID
- NCT05954728
- Run by
- Massachusetts General Hospital
- People needed
- 53
- Starts
- 2024-01-31
- Expected to finish
- 2026-03-27
- Last updated by the study team
- 2026-06-23
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
- 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
You may not qualify if…
- 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
Where it is running
- Eating Disorders Clinical and Research Program — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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