Comparing cognitive-behavioral therapy and nutrition counseling for ARFID in youth
Cognitive and Neural Mechanisms of Cognitive-behavioral Therapy for Avoidant/Restrictive Food Intake Disorder
This study is testing whether cognitive-behavioral therapy or nutrition counseling works better to help kids and teens with avoidant/restrictive food intake disorder feel better about eating.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 10 Years to 18 Years |
| Sex | All |
| Sponsor | Massachusetts General Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT05954728 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of cognitive-behavioral therapy (CBT-AR) versus nutrition counseling in treating avoidant/restrictive food intake disorder (ARFID) in children and adolescents aged 10 to 18 years. Participants will be randomly assigned to receive either CBT-AR or nutrition counseling to determine which intervention is more effective in addressing their eating disorder symptoms. The study aims to provide evidence-based treatment options for ARFID, a condition that can significantly impact growth and development in young individuals.
Who should consider this trial
Good fit: Ideal candidates for this study are males and females aged 10-18 years who are currently diagnosed with ARFID.
Not a fit: Patients with a BMI below the 5th percentile for their age and sex, or those requiring inpatient care due to medical instability, will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide effective therapeutic options for children and adolescents suffering from ARFID, improving their nutritional intake and overall well-being.
How similar studies have performed: Other studies have shown promising results with cognitive-behavioral therapy for eating disorders, suggesting that this approach may be effective for ARFID as well.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Boston, Massachusetts
- Eating Disorders Clinical and Research Program — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Study coordinator: Jennifer J Thomas, PhD
- Email: jjthomas@mgh.harvard.edu
- Phone: 617-643-6306
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.