๐ฌIn plain words
What the trial is, and whether it could suit you
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).
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
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
๐
What it tests
- Cognitive-Behavioral Therapy for Avoidance Restrictive Food Intake Disorder (CBT-AR)
- Nutrition Counseling for Avoidant/Restrictive Food Intake Disorder
Eating Disorders Clinical and Research Program
Boston, United States
๐ค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ always decide together with your own doctor.