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Behavioral Intervention

CBT-AR for Picky Eating (COUNTERACT Trial)

N/A

Recruiting

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Males and Females ages 10-18 years old

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from baseline neural activation in response to food cues measured at pre-treatment to after 15 weeks of treatment measured at post-treatment

Awards & highlights

COUNTERACT Trial Summary

This trial will test if therapy and nutrition counseling can help children and teenagers with avoidant/restrictive food intake disorder (ARFID).

Who is the study for?

This trial is for children and teens aged 10-18 with Avoidant/Restrictive Food Intake Disorder (ARFID), also known as picky eating. Participants must have normal thyroid levels, no active celiac disease, and be fluent in English.Check my eligibility

What is being tested?

The study compares two treatments for ARFID: Cognitive-Behavioral Therapy (CBT-AR) and Nutrition Counseling. It's a randomized trial, meaning participants are randomly assigned to one of the treatments to test effectiveness.See study design

What are the potential side effects?

Since this trial involves therapy and counseling rather than medication, side effects may include emotional discomfort or stress during sessions but typically do not involve physical symptoms.

COUNTERACT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 10 and 18 years old.

COUNTERACT Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline measured at pre-treatment to after 15 weeks of treatment measured at post-treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from baseline measured at pre-treatment to after 15 weeks of treatment measured at post-treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline measured at pre-treatment to after 15 weeks of treatment measured at post-treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Food Neophobia Scale

Functional magnetic resonance imaging (fMRI) food cue paradigm

Secondary outcome measures

24-Hour Recall measuring percent of calories consumed from fruits, vegetables, proteins, grains, and dairy food groups.

4-Day Food Record measuring percent of calories consumed from fruits, vegetables, proteins, grains, and dairy food groups.

General Nutrition Knowledge Questionnaire (GNKQ)

+2 more

COUNTERACT Trial Design

2Treatment groups

Experimental Treatment

Group I: Nutrition CounselingExperimental Treatment1 Intervention

Group II: CBT-ARExperimental Treatment1 Intervention

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor

2,935 Previous Clinical Trials

13,198,591 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the enrollment process open for this medical study at present?

"As documented on clinicaltrials.gov, this investigation is currently in the process of recruiting volunteers. The trial was first listed on January 31st, 2024 and most recently revised on February 22nd, 2024."

Answered by AI

Is the trial open to participants younger than 55 years of age?

"Participants aged 10 to under 18 years old are being sought for enrollment in this study."

Answered by AI

What is the upper limit for the number of participants involved in this research investigation?

"Affirmative. clinicaltrials.gov data confirms that this investigation is actively seeking volunteers. Originally shared on 1/31/2024, the latest update was made on 2/22/2024. The study aims to enroll 50 participants from a single site."

Answered by AI

Am I eligible to participate in this research study?

"This research is seeking to enroll 50 participants aged 10 to 18 with selective eating habits. Eligible individuals must be males or females between the ages of 10 and 18, diagnosed with Avoidant/Restrictive Food Intake Disorder (ARFID), have normal thyroid function tests ruling out thyroid disorders as a cause, negative results on celiac screening for active celiac disease, and possess proficiency in English language comprehension and literacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Jennifer Thomas 2024. "Cognitive-behavioral Therapy vs. Nutrition Counseling for Avoidant/Restrictive Food Intake Disorder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05954728.