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

NCT ID: NCT05954728

Last Updated: 2026-01-08

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-31
• Study Completion Date: 2026-03-31

Brief 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).

Conditions

Avoidant/Restrictive Food Intake Disorder (ARFID)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

CBT-AR

See intervention description

Group Type: EXPERIMENTAL

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

Intervention Type: BEHAVIORAL

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

See intervention description

Group Type: EXPERIMENTAL

Nutrition Counseling for Avoidant/Restrictive Food Intake Disorder

Intervention Type: BEHAVIORAL

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.

Interventions

Cognitive-Behavioral Therapy for Avoidant/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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jennifer Thomas

Eating Disorder Clinical and Research Program (EDCRP) Co-Director/Associate Professor of Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Eating Disorders Clinical and Research Program

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

2023P001491

Identifier Type: -

Identifier Source: org_study_id