Cognitive and Neural Mechanisms of Cognitive-Behavioral Therapy for Avoidant/Restrictive Food Intake Disorder Part II: Mediation Effects
| Registry | NCT07641205, acronym COUNTERACT-2 |
|---|---|
| Status | Not yet recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: double, treatment |
| Enrollment | 70 (Estimated) |
| Sponsor | Massachusetts General Hospital (Other) |
| Conditions | Avoidant/Restrictive Food Intake Disorder (ARFID) |
| Interventions | Cognitive-Behavioral Therapy for Avoidance Restrictive Food Intake Disorder (CBT-AR), Nutrition Counseling for Avoidant/Restrictive Food Intake Disorder (Behavioral) |
| Dates | start 2027-11-01 (estimated), primary completion 2029-10-01 (estimated), completion 2029-10-01 (estimated), first posted 2026-06-11, last updated 2026-10-07 |
| Locations | 1 site in United States |
Related Papers Related Patents Related Grants Related Experts
All trials for Avoidant/Restrictive Food Intake Disorder (ARFID) All trials of Cognitive-Behavioral Therapy for Avoidance Restrictive Food Intake Disorder (CBT-AR) All trials of Nutrition Counseling for Avoidant/Restrictive Food Intake Disorder
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).
| Arm | Type | Interventions | Description |
|---|---|---|---|
| CBT-AR | Experimental | Behavioral: Cognitive-Behavioral Therapy for Avoidance Restrictive Food Intake Disorder (CBT-AR) | See intervention description |
| Nutrition Counseling | Experimental | Behavioral: Nutrition Counseling for Avoidant/Restrictive Food Intake Disorder | See intervention description |
Sex: All, ages: 10 Years to 18 Years
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
| Facility | City | Country | Status |
|---|---|---|---|
| Eating Disorders Clinical and Research Program | Boston, Massachusetts | United States |