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Not yet recruiting NCT07641205

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

No phase Interventional Avoidant/Restrictive Food Intake Disorder (ARFID)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Cognitive-Behavioral Therapy for Avoidance Restrictive Food Intake Disorder (CBT-AR), Nutrition Counseling for Avoidant/Restrictive Food Intake Disorder.
Who it may be relevant to
Registry conditions: Avoidant/Restrictive Food Intake Disorder (ARFID). Basic parameters: 10 years — 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Cognitive and Neural Mechanisms of Cognitive-Behavioral Therapy for Avoidant/Restrictive Food Intake Disorder Part II: Mediation Effects

Overview

This study is a randomized controlled 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).

Interventions

  • Behavioral Cognitive-Behavioral Therapy for Avoidance 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.
  • 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.

Primary outcome measures

  • Pica, ARFID, and Rumination Disorder Interview [Time frame: Change from baseline measured at Pre-Treatment to Mid-Treatment to 15 weeks of treatment measured at Post-Treatment.]
  • Pica, ARFID, and Rumination Disorder ARFID Questionnaire [Time frame: Change from baseline measured at Pre-Treatment to Mid-Treatment to 15 weeks of treatment measured at Post-Treatment.]
Secondary outcome measures (2)
  • General Nutrition Knowledge Questionnaire [Time frame: Completed at Pre-Treatment Assessment (Baseline/Week 0), Mid-Treatment Assessment (Week 8 +/- 2 sessions), and Post-Treatment Assessment (Week 16 up to Week 19)]
  • 4-Day Food Record [Time frame: Completed at Pre-Treatment Assessment (Baseline/Week 0), Mid-Treatment Assessment (Week 8 +/- 2 sessions), and Post-Treatment Assessment (Week 16 up to Week 19)]

Eligibility criteria

Inclusion criteria

  • Males and Females ages 10-18 years old
  • Current ARFID assessed via Feeding and Eating Disorders Model from the "Enhanced" Structured Interview for DSM-5 (SCID-5)
  • Normal TSH or free T4 levels to rule out thyroid disease as cause of symptoms inclusionary for randomization
  • Negative celiac screening panel indicating no active celiac disease as cause of symptoms inclusionary for randomization
  • Fluency and literacy in English

Exclusion criteria

  • Patient requires weight restoration treatment (e.g., < 5th percentile of BMI, height, or weight for sex and age; patient has fallen off individual growth trajectory; patient's medical providers have recommended weight restoration) such that 15 sessions of CBT-AR is not appropriate
  • Pregnancy, breastfeeding, or recent initiation/cessation of estrogen-containing systemic contraceptives within 8 weeks of the pre-treatment study visit (as these could impact neuroimaging)
  • Current/history of psychosis via Mini-International Neuropsychiatric Interview child/adolescent version (MINI KID)
  • Substance/alcohol use disorder (active within the past month) via MINI KID
  • Medical instability requiring inpatient care according to the American Psychiatric Association 2006 treatment guidelines for eating disorders
  • Laboratory abnormalities indicating a need for higher level of care (assessed by complete blood count and comprehensive metabolic panel) exclusionary for randomization
  • Complete lack of oral intake (suggesting a need for inpatient care)
  • Tube feeding (suggesting a need for tube weaning) Significant weight/shape concern-motivating eating pathology as evidenced by a global Eating Disorders Examination Questionnaire (EDE-Q) score greater than 4
  • Active suicidal ideation with intent or plan via the 5-item Self-Injurious Thoughts and Behaviors Interview-Revised (SITBI-R)
  • Contraindications to MRI
  • History of major gastrointestinal tract surgery or serious medical condition (e.g., cancer)
  • Medical history of intellectual disability
  • Illiteracy

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Eating Disorders Clinical and Research Program — Boston

Identifiers

NCT: NCT07641205 · P202600305

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗