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

Study Overview
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Brief Summary
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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).

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

Conditions
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Avoidant/Restrictive Food Intake Disorder (ARFID)

Intervention / Treatment
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* Behavioral: Cognitive-Behavioral Therapy for Avoidant/Restrictive Food Intake Disorder (CBT-AR)
* Behavioral: Nutrition Counseling for Avoidant/Restrictive Food Intake Disorder


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CBT-AR<br> | Behavioral: Cognitive-Behavioral Therapy for Avoidant/Restrictive Food Intake Disorder (CBT-AR)<br>* 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.<br>|
| Experimental: Nutrition Counseling<br> | Behavioral: Nutrition Counseling for Avoidant/Restrictive Food Intake Disorder<br>* 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.<br>|

What is the study measuring?
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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 | Measure Description | 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 |