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

NCT07641205 | Not Yet Recruiting

• 1 other identifier: P202600305
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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)

Outcome Measures

Primary Outcomes (2)

• Pica, ARFID, and Rumination Disorder Interview

  A semi-structured clinical interview assessing the symptoms and severity of Pica, ARFID, and Rumination Disorder. This interview is used to determine the presence and severity of each ARFID profile. Scores for each severity measure are assessed on a scale from 0 to 6, with higher scores indicating greater severity.

  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

  A 32-item revised version of the Pica, ARFID, and Rumination Disorder Interview used to assess ARFID severity and presence of Pica or Rumination Disorder. Each item is assessed on a scale from 0 to 6, with higher scores indicating greater severity.

  Change from baseline measured at Pre-Treatment to Mid-Treatment to 15 weeks of treatment measured at Post-Treatment.

Secondary Outcomes (2)

• General Nutrition Knowledge Questionnaire

  Completed at Pre-Treatment Assessment (Baseline/Week 0), Mid-Treatment Assessment (Week 8 +/- 2 sessions), and Post-Treatment Assessment (Week 16 up to Week 19)

• 4-Day Food Record

  Completed at Pre-Treatment Assessment (Baseline/Week 0), Mid-Treatment Assessment (Week 8 +/- 2 sessions), and Post-Treatment Assessment (Week 16 up to Week 19)

Study Arms (2)

CBT-AR

EXPERIMENTAL

See intervention description

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

Nutrition Counseling

EXPERIMENTAL

See intervention description

Behavioral: Nutrition Counseling for Avoidant/Restrictive Food Intake Disorder

Interventions

Nutrition Counseling for Avoidant/Restrictive Food Intake Disorder 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.

Nutrition Counseling

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

CBT-AR

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)
• Fluency and literacy in English

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Eating Disorders Clinical and Research Program

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Avoidant Restrictive Food Intake Disorder

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

Jennifer J. Thomas, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Eating Disorder Clinical and Research Program (EDCRP) Co-Director/Professor of Psychiatry

Study Record Dates

• First Submitted: May 28, 2026
• First Posted: June 11, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): September 1, 2029
• Last Updated: June 11, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share

Locations

US (1)