Recruiting

CBT-AR & Nutrition Counseling

Sponsor:

Massachusetts General Hospital

Code:

NCT07641205

Conditions

Avoidant/Restrictive Food Intake Disorder (ARFID)

Eligibility Criteria

Sex: All

Age: 10 - 18

Healthy Volunteers: Not accepted

Interventions

Cognitive-Behavioral Therapy for Avoidance Restrictive Food Intake Disorder (CBT-AR)

Nutrition Counseling for Avoidant/Restrictive Food Intake Disorder

Study Details

Brief summary:

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).

Conditions

Avoidant/Restrictive Food Intake Disorder (ARFID)

Study ID

NCT07641205

Start date

Nov, 2026

Status verified date

Oct, 2026

Completion date

Oct, 2029

Anticipated

Primary completion date

Oct, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 10 - 18

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

70 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: CBT-AR

See intervention description

experimental: Nutrition Counseling

See intervention description

Interventions

Cognitive-Behavioral Therapy for Avoidance Restrictive Food Intake Disorder (CBT-AR)

CBT-AR is a four-stage modular treatment for ARFID delivered by a mental health clinician. The four stages include: 1) Psychoeducation and early change; 2) Treatment planning; 3) Addressing maintaining mechanisms; and 4) Relapse prevention. For participants ages 10-15 years, patients/guardians attend the sessions. For patients ages 16 and up, the therapy is individual.

Nutrition Counseling for Avoidant/Restrictive Food Intake Disorder

Nutrition counseling will be provided by skilled registered dietitians at the MGH Translational and Clinical Research Center (TCRC). Sessions focus on the foods necessary for a healthy diet, how to meet nutritional needs, how to incorporate healthy exercise, and support for making these changes. For participants ages 10-15 years, patients/guardians attend the sessions. For patients ages 16 and up, the therapy is individual.

Primary outcome measure

  • Pica, ARFID, and Rumination Disorder Interview [ Time Frame: Change from baseline measured at Pre-Treatment to Mid-Treatment to 15 weeks of treatment measured at Post-Treatment. ]
  • Pica, ARFID, and Rumination Disorder ARFID Questionnaire [ Time Frame: Change from baseline measured at Pre-Treatment to Mid-Treatment to 15 weeks of treatment measured at Post-Treatment. ]

Central Contacts and Locations

Central contacts

Jennifer J. Thomas, PhD

617-643-6306jjthomas@mgh.harvard.edu

Locations

Eating Disorders Clinical and Research Program

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Stefania Yee

617-724-0799syee5@mgh.harvard.edu

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Oct 26, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-27. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2026-10-26. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.