Cognitive-behavioral Therapy vs. Nutrition Counseling for Avoidant/Restrictive Food Intake Disorder (COUNTERACT)

Mass General Brigham

Status

Enrolling

Conditions

Avoidant/Restrictive Food Intake Disorder (ARFID)

Treatments

Behavioral: Nutrition Counseling for Avoidant/Restrictive Food Intake Disorder

Behavioral: Cognitive-Behavioral Therapy for Avoidant/Restrictive Food Intake Disorder (CBT-AR)

Study type

Interventional

Funder types

Other

Identifiers

NCT05954728

2023P001491

Details and patient eligibility

About

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).

Enrollment

50 estimated patients

Sex

All

Ages

10 to 18 years old

Volunteers

No Healthy Volunteers

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