Back to resultsCognitive-behavioral Therapy vs. Nutrition Counseling for Avoidant/Restrictive Food Intake Disorder (COUNTERACT)
Primary Purpose
Avoidant/Restrictive Food Intake Disorder (ARFID)
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Cognitive-Behavioral Therapy for Avoidant/Restrictive Food Intake Disorder (CBT-AR)
Nutrition Counseling for Avoidant/Restrictive Food Intake Disorder
Sponsored by
About this trial
This is an interventional treatment trial for Avoidant/Restrictive Food Intake Disorder (ARFID)
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
CBT-AR
Nutrition Counseling
Arm Description
Outcomes
Primary Outcome Measures
Food Neophobia Scale
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.
Functional magnetic resonance imaging (fMRI) food cue paradigm
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.
Secondary Outcome Measures
General Nutrition Knowledge Questionnaire (GNKQ)
Pica, ARFID, and Rumination Disorder Interview (PARDI)
Pica, ARFID, and Rumination Disorder ARFID Questionnaire (PARDI-AR-Q)
4-Day Food Record measuring percent of calories consumed from fruits, vegetables, proteins, grains, and dairy food groups.
24-Hour Recall measuring percent of calories consumed from fruits, vegetables, proteins, grains, and dairy food groups.
Full Information
NCT ID
NCT05954728
First Posted
July 5, 2023
Last Updated
July 19, 2023
Sponsor
Massachusetts General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05954728
Brief Title
Cognitive-behavioral Therapy vs. Nutrition Counseling for Avoidant/Restrictive Food Intake Disorder
Acronym
COUNTERACT
Official Title
Cognitive and Neural Mechanisms of Cognitive-behavioral Therapy for Avoidant/Restrictive Food Intake Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
September 2025 (Anticipated)
Study Completion Date
September 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Avoidant/Restrictive Food Intake Disorder (ARFID)
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CBT-AR
Arm Type
Experimental
Arm Title
Nutrition Counseling
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Cognitive-Behavioral Therapy for Avoidant/Restrictive Food Intake Disorder (CBT-AR)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Nutrition Counseling for Avoidant/Restrictive Food Intake Disorder
Intervention Description
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.
Primary Outcome Measure Information:
Title
Food Neophobia Scale
Description
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.
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
Title
Functional magnetic resonance imaging (fMRI) food cue paradigm
Description
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.
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
Secondary Outcome Measure Information:
Title
General Nutrition Knowledge Questionnaire (GNKQ)
Time Frame
Change from baseline measured at pre-treatment to after 15 weeks of treatment measured at post-treatment
Title
Pica, ARFID, and Rumination Disorder Interview (PARDI)
Time Frame
Change from baseline measured at pre-treatment to after 15 weeks of treatment measured at post-treatment
Title
Pica, ARFID, and Rumination Disorder ARFID Questionnaire (PARDI-AR-Q)
Time Frame
Change from baseline measured at pre-treatment to after 15 weeks of treatment measured at post-treatment
Title
4-Day Food Record measuring percent of calories consumed from fruits, vegetables, proteins, grains, and dairy food groups.
Time Frame
Change from baseline measured at pre-treatment to after 15 weeks of treatment measured at post-treatment
Title
24-Hour Recall measuring percent of calories consumed from fruits, vegetables, proteins, grains, and dairy food groups.
Time Frame
Change from baseline measured at pre-treatment to after 15 weeks of treatment measured at post-treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jennifer J Thomas, PhD
Phone
617-643-6306
Email
jjthomas@mgh.harvard.edu
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The investigators will upload de-identified data to the NIMH National Data Archive at the conclusion of the study
Learn more about this trial
Cognitive-behavioral Therapy vs. Nutrition Counseling for Avoidant/Restrictive Food Intake Disorder
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