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

Conditions

• Avoidant/Restrictive Food Intake Disorder (ARFID)

Eligibility Criteria

Sex

ALL

Age

10 Years - 18 Years

Healthy Volunteers

Not accepted

Interventions

• 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.

Study Details

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).

Key Dates

Start date

Jun 30, 2026

Status verified

Jun 2026

Primary completion

Sep 30, 2029

Completion

Sep 30, 2029

Study Design

Enrollment

70 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: CBT-AR
  See intervention description
• Experimental: Nutrition Counseling
  See intervention description

Primary Outcome Measure

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. ]

Central Contacts

• Jennifer J. Thomas, PhD
  617-643-6306
  [email protected]

Locations (1)

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