CompletedNot Applicable

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

United States53 participantsStarted 2024-01-31

Plain-language summary

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).

Who can participate

Age range

10 Years – 18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Food Neophobia Scale

Timeframe: Change from baseline food neophobia measured at pre-treatment to after each weekly session of treatment and after the complete 15 weeks of treatment measured at post-treatment

Functional magnetic resonance imaging (fMRI) food cue paradigm

Timeframe: Change from baseline neural activation in response to food cues measured at pre-treatment to after 15 weeks of treatment measured at post-treatment

Trial details

NCT IDNCT05954728

SponsorMassachusetts General Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-03-27

View on ClinicalTrials.gov More Avoidant/Restrictive Food Intake Disorder (ARFID) trials