Cognitive-Behavioral Therapy vs Nutrition Counseling for ARFID

(COUNTERACT-2 Trial)

JJ
Overseen ByJennifer J. Thomas, PhD
Age: < 65
Sex: Any
Trial Phase: Academic
Sponsor: Massachusetts General Hospital
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two different treatments for children and teens with avoidant/restrictive food intake disorder (ARFID). One group receives cognitive-behavioral therapy (CBT-AR), which focuses on changing thought patterns to improve eating habits. The other group receives nutrition counseling to help them make healthier food choices. Children and teens aged 10 to 18, diagnosed with ARFID and without conditions like thyroid disease or celiac disease, are suitable candidates for this study. The goal is to determine which approach is more effective for treating ARFID. As an unphased trial, this study allows participants to contribute to important research that could enhance treatment options for ARFID.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Earlier studies have shown that cognitive-behavioral therapy for avoidant/restrictive food intake disorder (ARFID) is well-received by children and teens. Research indicates that this therapy helps them try more types of food and gain weight, with no major side effects reported.

Similarly, nutrition counseling, another treatment for ARFID, has demonstrated good results. Participants reported improved eating habits and food choices. No major negative side effects have been reported from this treatment either.

Overall, both cognitive-behavioral therapy and nutrition counseling appear safe and helpful for treating ARFID in young people.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for Avoidance Restrictive Food Intake Disorder (ARFID) because they offer new approaches beyond traditional options like exposure therapy or medications. Cognitive-Behavioral Therapy for ARFID (CBT-AR) is unique because it specifically targets the thought patterns and behaviors that contribute to restrictive eating, helping patients develop healthier relationships with food. On the other hand, Nutrition Counseling focuses on personalized dietary education, aiming to address nutritional deficiencies and promote balanced eating habits. These treatments provide a more tailored approach, addressing both psychological and nutritional aspects of ARFID, which could lead to more comprehensive and lasting solutions for patients.

What evidence suggests that this trial's treatments could be effective for ARFID?

This trial will compare Cognitive-Behavioral Therapy for ARFID (CBT-AR) with Nutrition Counseling for individuals with Avoidant/Restrictive Food Intake Disorder. Research has shown that CBT-AR can help children and teens improve their eating habits, with early findings suggesting that participants often start eating a wider variety of foods. This therapy reduces food avoidance and increases the range of foods eaten. Meanwhile, Nutrition Counseling has benefited many people with ARFID by focusing on improving nutritional health and encouraging a more varied diet, which can address immediate health issues related to ARFID. Both treatments target different aspects of the disorder and offer potential benefits for those affected.12367

Are You a Good Fit for This Trial?

This trial is for boys and girls aged 10-18 who have been diagnosed with avoidant/restrictive food intake disorder (ARFID). Participants must not have thyroid disease or celiac disease, and they need to be able to read and speak English.

Inclusion Criteria

I am between 10 and 18 years old.
Negative celiac screening panel indicating no active celiac disease as cause of symptoms inclusionary for randomization
Current ARFID assessed via Feeding and Eating Disorders Model from the 'Enhanced' Structured Interview for DSM-5 (SCID-5)
See 2 more

Exclusion Criteria

I have had major stomach or intestinal surgery or a serious illness like cancer.
Substance/alcohol use disorder active within the past month via MINI KID
Laboratory abnormalities indicating a need for higher level of care assessed by complete blood count and comprehensive metabolic panel exclusionary for randomization
See 11 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive cognitive-behavioral therapy (CBT-AR) or nutrition counseling for avoidant/restrictive food intake disorder

15 weeks
Pre-Treatment, Mid-Treatment, and Post-Treatment assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Cognitive-Behavioral Therapy for Avoidance Restrictive Food Intake Disorder (CBT-AR)
  • Nutrition Counseling for Avoidant/Restrictive Food Intake Disorder

Trial Overview

The study compares two treatments for ARFID in children and teens: cognitive-behavioral therapy (CBT-AR) versus nutrition counseling. Participants are randomly assigned to one of the two groups.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Nutrition CounselingExperimental Treatment1 Intervention
Group II: CBT-ARExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials
3,066
Recruited
13,430,000+

Citations

Cognitive-Behavioral Treatment of Avoidant/Restrictive Food ...

The purpose of this paper is to review the recent literature on ARFID treatment and highlight a novel cognitive-behavioral approach presently under study.

An evaluation of Cognitive-Behavioral Therapy for ...

While a single case study has reported positive results, no clinical trial of FBI-ARFID has been published and it remains unclear how effective the treatment is ...

Cognitive-behavioral Therapy vs. Nutrition Counseling for ...

This study is a randomized controlled trial assessing the efficacy of cognitive- behavioral therapy (CBT-AR) and nutrition counseling for ...

Cognitive Behavioral Therapy for Avoidant/Restrictive Food ...

Early data from our preliminary efficacy studies indicate that, on average, patients who receive CBT-AR incorporate many novel foods into their regular diets, ...

Predictors of outcome in cognitive-behavioral therapy ... - PMC

Cognitive-behavioral therapy for avoidant/restrictive food intake disorder (ARFID; CBT-AR) shows promise in improving clinical outcomes in children/adolescents ...

Integrating cognitive-behavioral and medical interventions for ...

Olanzapine has been effective in reducing cognitive rigidity and anxiety, thus facilitating weight gain in ARFID patients [38]. Lorazepam was ...

Avoidant Restrictive Food Intake Disorder - StatPearls - NCBI

Cognitive behavior therapy for ARFID: This therapy addresses nutritional deficiency, increases exposure to new foods, and reduces negative ...