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Completed

NCT Number: NCT05954728

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

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).

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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, 02139, United States

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
  • 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

Treatment and study plan

Cognitive-Behavioral Therapy for Avoidant/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. Food Neophobia Scale

    Time frame: 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.

  2. Functional magnetic resonance imaging (fMRI) food cue paradigm

    Time frame: 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.

Secondary outcomes

  1. General Nutrition Knowledge Questionnaire (GNKQ)

    Time frame: Change from baseline measured at pre-treatment to after 15 weeks of treatment measured at post-treatment

    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. Pica, ARFID, and Rumination Disorder Interview (PARDI)

    Time frame: Change from baseline measured at pre-treatment to after 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.

  3. Pica, ARFID, and Rumination Disorder ARFID Questionnaire (PARDI-AR-Q)

    Time frame: Change from baseline measured at pre-treatment to after 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.

  4. 4-Day Food Record measuring percent of calories consumed from fruits, vegetables, proteins, grains, and dairy food groups.

    Time frame: Change from baseline measured at pre-treatment to after 15 weeks of treatment measured at post-treatment

    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.

  5. 24-Hour Recall measuring percent of calories consumed from fruits, vegetables, proteins, grains, and dairy food groups.

    Time frame: Change from baseline measured at pre-treatment to after 15 weeks of treatment measured at post-treatment

    A detailed recall of everything a participant has consumed during the 24 hours prior to the Pre-Treatment Assessment, and again prior to the Post-Treatment Assessment. Dietary information is calculated from the recorded foods.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

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

Acronym: COUNTERACT

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 20, 2023
Registry last updated
Jun 23, 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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