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

Cognitive and Neural Mechanisms of Cognitive-behavioral Therapy for Avoidant/Restrictive Food Intake Disorder

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).

Study Overview

• Status: Recruiting
• Conditions: Avoidant/Restrictive Food Intake Disorder (ARFID)
• Intervention / Treatment: Behavioral: Cognitive-Behavioral Therapy for Avoidant/Restrictive Food Intake Disorder (CBT-AR); Behavioral: Nutrition Counseling for Avoidant/Restrictive Food Intake Disorder

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jennifer J Thomas, PhD; Phone Number: 617-643-6306; Email: jjthomas@mgh.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02139
      • Recruiting
      • Eating Disorders Clinical and Research Program
      • Contact: Lilian Palmer; Phone Number: 617-724-0799

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CBT-AR	Behavioral: 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.
Experimental: Nutrition Counseling	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2024
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: July 5, 2023
• First Submitted That Met QC Criteria: July 12, 2023
• First Posted (Actual): July 20, 2023

Study Record Updates

• Last Update Posted (Actual): February 26, 2024
• Last Update Submitted That Met QC Criteria: February 22, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Feeding and Eating Disorders; Avoidant Restrictive Food Intake Disorder
• Other Study ID Numbers: 2023P001491

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The investigators will upload de-identified data to the NIMH National Data Archive at the conclusion of the study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No