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

NCT05954728 | Completed

• 1 other identifier: 2023P001491
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

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)

Outcome Measures

Primary Outcomes (2)

• Food Neophobia Scale

  Validated 6-item version of the Food Neophobia Scale used to assess food neophobia on a scale from 1 to 7, with higher scores indicating higher levels of food neophobia. The lowest score possible is 7, indicating low food neophobia, and highest score possible is 42, indicating high food neophobia.

  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

  Used to measure neural activation in response to food cues. Higher scores indicate higher neural activation. There is no minimum or maximum for this measure.

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

Secondary Outcomes (5)

• General Nutrition Knowledge Questionnaire (GNKQ)

  Change from baseline measured at pre-treatment to after 15 weeks of treatment measured at post-treatment

• Pica, ARFID, and Rumination Disorder Interview (PARDI)

  Change from baseline measured at pre-treatment to after 15 weeks of treatment measured at post-treatment

• Pica, ARFID, and Rumination Disorder ARFID Questionnaire (PARDI-AR-Q)

  Change from baseline measured at pre-treatment to after 15 weeks of treatment measured at post-treatment

• 4-Day Food Record measuring percent of calories consumed from fruits, vegetables, proteins, grains, and dairy food groups.

  Change from baseline measured at pre-treatment to after 15 weeks of treatment measured at post-treatment

• 24-Hour Recall measuring percent of calories consumed from fruits, vegetables, proteins, grains, and dairy food groups.

  Change from baseline measured at pre-treatment to after 15 weeks of treatment measured at post-treatment

Study Arms (2)

CBT-AR

EXPERIMENTAL

See intervention description

Behavioral: Cognitive-Behavioral Therapy for Avoidant/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 Avoidant/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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Eating Disorders Clinical and Research Program

Boston, Massachusetts, 02139, 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

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/Associate Professor of Psychiatry

Study Record Dates

• First Submitted: July 5, 2023
• First Posted: July 20, 2023
• Study Start: January 31, 2024
• Primary Completion: March 27, 2026
• Study Completion: March 27, 2026
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

US (1)