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Completed
NCT05954728
Cognitive-behavioral Therapy vs. Nutrition Counseling for Avoidant/Restrictive Food Intake Disorder
Conditions: Avoidant/Restrictive Food Intake Disorder (ARFID)
Sex: All
Ages: 10 Years – 18 Years
Healthy volunteers: No
Phase: NA
Enrollment: 53
Sponsor: Massachusetts General Hospital
Location: Eating Disorders Clinical and Research Program Boston Massachusetts
Summary
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).
Eligibility Criteria
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Source: ClinicalTrials.gov (NCT05954728). StuddyBuddy aggregates publicly available trial information.