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

Not Applicable

Recruiting

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

• Registration Number: NCT05954728
• Lead Sponsor: Massachusetts General Hospital

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-07-05
• Study First Submitted QC: 2023-07-12
• Study First Posted: 2023-07-20
• Study Start: 2024-01-31
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-02
• Last Update Posted: 2024-07-05
• Primary Completion: 2025-08-31
• Study Completion: 2025-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nutrition Counseling	Nutrition Counseling for Avoidant/Restrictive Food Intake Disorder	-
CBT-AR	Cognitive-Behavioral Therapy for Avoidant/Restrictive Food Intake Disorder (CBT-AR)	-

Primary Outcome Measures

Name	Time	Method
Functional magnetic resonance imaging (fMRI) food cue paradigm	Change from baseline neural activation in response to food cues measured at pre-treatment to after 15 weeks of treatment measured at post-treatment	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.
Food Neophobia Scale	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	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.

Secondary Outcome Measures

Name	Time	Method
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
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
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
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

Trial Locations

Locations (1)

Eating Disorders Clinical and Research Program; 🇺🇸 Boston, Massachusetts, United States