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

Avoidant/Restrictive Food Intake Disorder (ARFID) Clinical Trial

— COUNTERACT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05954728
• Other study ID #: 2023P001491
• Status: Recruiting
• Phase: N/A
• Start date: January 31, 2024
• Est. completion date: September 2025

Study information

• Verified date: February 2024
• Source: Massachusetts General Hospital
• Contact: Jennifer J Thomas, PhD
• Phone: 617-643-6306
• Email: jjthomas[@]mgh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: September 2025
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Avoidant/Restrictive Food Intake Disorder (ARFID)

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Eating Disorders Clinical and Research Program	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	General Nutrition Knowledge Questionnaire (GNKQ)		Change from baseline measured at pre-treatment to after 15 weeks of treatment measured at post-treatment
Secondary	Pica, ARFID, and Rumination Disorder Interview (PARDI)		Change from baseline measured at pre-treatment to after 15 weeks of treatment measured at post-treatment
Secondary	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
Secondary	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
Secondary	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