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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age10-18
SponsorMassachusetts General Hospital

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: CBT-ARExperimental treatment 1 intervention
Group B: Nutrition CounselingExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Pica, ARFID, and Rumination Disorder Interview

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.

Time frame
Change from baseline measured at Pre-Treatment to Mid-Treatment to 15 weeks of treatment measured at Post-Treatment.
2

Pica, ARFID, and Rumination Disorder ARFID Questionnaire

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.

Time frame
Change from baseline measured at Pre-Treatment to Mid-Treatment to 15 weeks of treatment measured at Post-Treatment.

Secondary outcomes

1

General Nutrition Knowledge Questionnaire

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.

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)
2

4-Day Food Record

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.

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)

Other outcomes

Sponsors and contacts

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