Clinical trial NCT05954728: Cognitive-behavioral Therapy vs. Nutrition Counseling for Avoidant/Restrictive Food Intake Disorder
Official title: Cognitive and Neural Mechanisms of Cognitive-behavioral Therapy for Avoidant/Restrictive Food Intake Disorder
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Avoidant/Restrictive Food Intake Disorder (ARFID)
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2023-07-20
Enrollment: 50
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).


Eligibility criteria: 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

Primary outcomes:
measure: Food Neophobia Scale
timeFrame: 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
measure: Functional magnetic resonance imaging (fMRI) food cue paradigm
timeFrame: Change from baseline neural activation in response to food cues measured at pre-treatment to after 15 weeks of treatment measured at post-treatment
Secondary outcomes:
measure: General Nutrition Knowledge Questionnaire (GNKQ)
timeFrame: Change from baseline measured at pre-treatment to after 15 weeks of treatment measured at post-treatment
measure: Pica, ARFID, and Rumination Disorder Interview (PARDI)
timeFrame: Change from baseline measured at pre-treatment to after 15 weeks of treatment measured at post-treatment
measure: Pica, ARFID, and Rumination Disorder ARFID Questionnaire (PARDI-AR-Q)
timeFrame: Change from baseline measured at pre-treatment to after 15 weeks of treatment measured at post-treatment
measure: 4-Day Food Record measuring percent of calories consumed from fruits, vegetables, proteins, grains, and dairy food groups.
timeFrame: Change from baseline measured at pre-treatment to after 15 weeks of treatment measured at post-treatment
measure: 24-Hour Recall measuring percent of calories consumed from fruits, vegetables, proteins, grains, and dairy food groups.
timeFrame: Change from baseline measured at pre-treatment to after 15 weeks of treatment measured at post-treatment
Other outcomes:
Locations:
city: Boston
country: United States
facility: Eating Disorders Clinical and Research Program
state: Massachusetts
Study officials:
References: