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Search / Trial NCT05954728

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

Launched by MASSACHUSETTS GENERAL HOSPITAL · Jul 12, 2023

Trial Information

Current as of July 27, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is looking at two different ways to help children and teenagers, aged 10 to 18, who have Avoidant/Restrictive Food Intake Disorder (ARFID). ARFID is a condition where someone has a very limited diet and may avoid certain foods due to their taste, texture, or other reasons. The study will compare cognitive-behavioral therapy (CBT-AR), which focuses on changing thoughts and behaviors related to eating, with nutrition counseling, which provides guidance on healthy eating habits.

To be eligible for this trial, participants need to be between 10 and 18 years old and currently diagnosed with ARFID. They should also have normal thyroid function and no active celiac disease, which means their symptoms aren't caused by these conditions. Unfortunately, those with very low body weight, certain mental health issues, or serious medical conditions may not qualify. If chosen for the study, participants will receive treatment tailored to their needs and will contribute to important research that could improve care for others facing similar challenges.

Gender

ALL

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

About Massachusetts General Hospital

Massachusetts General Hospital (MGH) is a leading academic medical center located in Boston, Massachusetts, renowned for its commitment to advancing medical research and patient care. As a prominent teaching hospital affiliated with Harvard Medical School, MGH plays a pivotal role in clinical trials across a wide range of disciplines, including cardiology, oncology, neurology, and more. The institution is dedicated to fostering innovative research that translates into effective therapies and improved health outcomes. MGH's Clinical Trials Office provides comprehensive support to facilitate the design, implementation, and management of clinical studies, ensuring adherence to the highest ethical standards and regulatory compliance. With a focus on collaboration and patient-centered care, MGH strives to enhance medical knowledge and contribute to the future of healthcare.

Locations

Boston, Massachusetts, United States

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported