NCT07641205
Cognitive-behavioral Therapy vs. Nutrition Counseling for Avoidant/Restrictive Food Intake Disorder Part II
Not Yet Recruiting
NAAges 10–18InterventionalTreatmentMassachusetts General HospitalInvestigator-initiated
~70 participants
Updated 2026-06-15 on ClinicalTrials.gov
What's tested:Cognitive-Behavioral Therapy for Avoidance Restrictive Food Intake Disorder (CBT-AR)Nutrition Counseling for Avoidant/Restrictive Food Intake Disorder
At a glance
Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Pica, ARFID, and Rumination Disorder Interview
Measured over Change from baseline measured at Pre-Treatment to Mid-Treatment to 15 weeks of treatment measured at Post-Treatment.
+1 more outcome measured
Conditions
Where it's being run
1 sites across 1 statesMassachusetts1
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
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
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
What this trial measures
- Pica, ARFID, and Rumination Disorder InterviewChange from baseline measured at Pre-Treatment to Mid-Treatment to 15 weeks of treatment measured at Post-Treatment.
A semi-structured clinical interview assessing the symptoms and severity of Pica, ARFID, and Rumination Disorder. This interview is used to determine the presence and severity of each ARFID profile. Scores for each severity measure are assessed on a scale from 0 to 6, with higher scores indicating greater severity.
- Pica, ARFID, and Rumination Disorder ARFID QuestionnaireChange from baseline measured at Pre-Treatment to Mid-Treatment to 15 weeks of treatment measured at Post-Treatment.
A 32-item revised version of the Pica, ARFID, and Rumination Disorder Interview used to assess ARFID severity and presence of Pica or Rumination Disorder. Each item is assessed on a scale from 0 to 6, with higher scores indicating greater severity.