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NCT Number: NCT07641205

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

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).

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Key information

Conditions

Avoidant/Restrictive Food Intake Disorder (ARFID) Avoidant Restrictive Food Intake Disorder Feeding and Eating Disorders Mental Disorders

Age range

10 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Eating Disorders Clinical and Research Program

Boston, Massachusetts, 02114, United States

Location contact

Stefania Yee

CONTACT

[email protected]

617-724-0799

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive-Behavioral Therapy for Avoidance Restrictive Food Intake Disorder (CBT-AR)

Behavioral

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

Behavioral

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 outcomes

  1. 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.

    A semi-structured clinical interview assessing the symptoms and severity of Pica, ARFID, and Rumination Disorder. This interview is used to determine the presence and severity of each ARFID profile. Scores for each severity measure are assessed on a scale from 0 to 6, with higher scores indicating greater severity.

  2. 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.

    A 32-item revised version of the Pica, ARFID, and Rumination Disorder Interview used to assess ARFID severity and presence of Pica or Rumination Disorder. Each item is assessed on a scale from 0 to 6, with higher scores indicating greater severity.

Secondary outcomes

  1. 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)

    A revised version of the General Nutrition Knowledge Questionnaire (GNKQ) used to evaluate knowledge of nutrition. Scores are gathered through a series of multiple-choice questions. The lowest score possible is 0, indicating low knowledge of nutrition, and the highest score possible is 14, indicating high knowledge of nutrition.

  2. 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)

    A record of participant diet for four days prior to the Pre-Treatment Assessment and for another four days prior to the Post-Treatment Assessment. Dietary information is calculated from the recorded foods.

Study contacts

Contact information is provided by the study sponsor or research team.

Jennifer J. Thomas, PhD

CONTACT

[email protected]

617-643-6306

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study title

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

Acronym: COUNTERACT-2

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Jun 11, 2026
Registry last updated
Jun 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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