Cognitive and Neural Mechanisms of Cognitive-behavioral Therapy for Avoidant/Restrictive Food Intake Disorder
Overview
- Phase
- N/A
- Intervention
- Cognitive-Behavioral Therapy for Avoidant/Restrictive Food Intake Disorder (CBT-AR)
- Conditions
- Avoidant/Restrictive Food Intake Disorder (ARFID)
- Sponsor
- Massachusetts General Hospital
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Functional magnetic resonance imaging (fMRI) food cue paradigm
- Status
- Active, Not Recruiting
- Last Updated
- 3 months ago
Overview
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).
Investigators
Jennifer Thomas
Eating Disorder Clinical and Research Program (EDCRP) Co-Director/Associate Professor of Psychiatry
Massachusetts General Hospital
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
Arms & Interventions
CBT-AR
See intervention description
Intervention: Cognitive-Behavioral Therapy for Avoidant/Restrictive Food Intake Disorder (CBT-AR)
Nutrition Counseling
See intervention description
Intervention: Nutrition Counseling for Avoidant/Restrictive Food Intake Disorder
Outcomes
Primary Outcomes
Functional magnetic resonance imaging (fMRI) food cue paradigm
Time Frame: Change from baseline neural activation in response to food cues measured at pre-treatment to after 15 weeks of treatment measured at post-treatment
Used to measure neural activation in response to food cues. Higher scores indicate higher neural activation. There is no minimum or maximum for this measure.
Food Neophobia Scale
Time Frame: 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
Validated 6-item version of the Food Neophobia Scale used to assess food neophobia on a scale from 1 to 7, with higher scores indicating higher levels of food neophobia. The lowest score possible is 7, indicating low food neophobia, and highest score possible is 42, indicating high food neophobia.
Secondary Outcomes
- General Nutrition Knowledge Questionnaire (GNKQ)(Change from baseline measured at pre-treatment to after 15 weeks of treatment measured at post-treatment)
- Pica, ARFID, and Rumination Disorder Interview (PARDI)(Change from baseline measured at pre-treatment to after 15 weeks of treatment measured at post-treatment)
- Pica, ARFID, and Rumination Disorder ARFID Questionnaire (PARDI-AR-Q)(Change from baseline measured at pre-treatment to after 15 weeks of treatment measured at post-treatment)
- 4-Day Food Record measuring percent of calories consumed from fruits, vegetables, proteins, grains, and dairy food groups.(Change from baseline measured at pre-treatment to after 15 weeks of treatment measured at post-treatment)
- 24-Hour Recall measuring percent of calories consumed from fruits, vegetables, proteins, grains, and dairy food groups.(Change from baseline measured at pre-treatment to after 15 weeks of treatment measured at post-treatment)