ACTIVE_NOT_RECRUITING

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

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Conditions

Avoidant/Restrictive Food Intake Disorder (ARFID)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

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

Quick Facts

Study Start:2024-01-31
Study Completion:2026-03-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05954728

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:10 Years to 18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Males and Females ages 10-18 years old
  2. * Current ARFID
  3. * Normal TSH or free T4 levels to rule out thyroid disease as cause of symptoms
  4. * Negative celiac screening panel indicating no active celiac disease as cause of symptoms
  5. * Fluency and literacy in English
  1. * BMI \< 5th percentile for sex and age
  2. * Pregnancy, breastfeeding, or recent initiation/cessation of oral contraceptive pills within 8 weeks of the pre-treatment study visit
  3. * Current/history of psychosis
  4. * Substance/alcohol use disorder (active within the past month)
  5. * Medical instability requiring inpatient care according to the American Psychiatric Association 2023 treatment guidelines for eating disorders
  6. * Laboratory abnormalities indicating a need for higher level of care
  7. * Complete lack of oral intake (suggesting a need for inpatient care)
  8. * Tube feeding (suggesting a need for tube weaning)
  9. * Active suicidal/homicidal ideation with intent or plan
  10. * Contraindications to MRI
  11. * History of major gastrointestinal tract surgery or serious medical condition (e.g., cancer)
  12. * Medical history of intellectual disability
  13. * Illiteracy

Contacts and Locations

Study Locations (Sites)

Eating Disorders Clinical and Research Program
Boston, Massachusetts, 02139
United States

Collaborators and Investigators

Sponsor: Massachusetts General Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-01-31
Study Completion Date2026-03-31

Study Record Updates

Study Start Date2024-01-31
Study Completion Date2026-03-31

Terms related to this study

Additional Relevant MeSH Terms

  • Avoidant/Restrictive Food Intake Disorder (ARFID)