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

Sponsor

Massachusetts General Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05954728

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Avoidant/Restrictive Food Intake Disorder (ARFID)	Behavioral: Cognitive-Behavioral Therapy for Avoidant/Restrictive Food Intake Disorder (CBT-AR) Behavioral: Nutrition Counseling for Avoidant/Restrictive Food Intake Disorder	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Oct 1, 2023

Anticipated Primary Completion Date :

Sep 1, 2025

Anticipated Study Completion Date :

Sep 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CBT-AR	Behavioral: Cognitive-Behavioral Therapy for Avoidant/Restrictive Food Intake Disorder (CBT-AR) 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.
Experimental: Nutrition Counseling	Behavioral: Nutrition Counseling for Avoidant/Restrictive Food Intake Disorder 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.

Arm

Intervention/Treatment

Experimental: CBT-AR

Behavioral: Cognitive-Behavioral Therapy for Avoidant/Restrictive Food Intake Disorder (CBT-AR)

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.

Experimental: Nutrition Counseling

Behavioral: Nutrition Counseling for Avoidant/Restrictive Food Intake Disorder

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.

Outcome Measures

Primary Outcome Measures

Food Neophobia Scale [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.
Functional magnetic resonance imaging (fMRI) food cue paradigm [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.

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

10 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Massachusetts General Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jennifer Thomas, Eating Disorder Clinical and Research Program (EDCRP) Co-Director/Associate Professor of Psychiatry, Massachusetts General Hospital

ClinicalTrials.gov Identifier:

NCT05954728

Other Study ID Numbers:

2023P001491

First Posted:

Jul 20, 2023

Last Update Posted:

Jul 21, 2023

Last Verified:

Jul 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Avoidant Restrictive Food Intake Disorder

Study Results

No Results Posted as of Jul 21, 2023