50 Participants Needed

Therapy vs. Nutrition Counseling for Picky Eating

(COUNTERACT 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 explores two approaches to help children and teens with avoidant/restrictive food intake disorder (ARFID), which causes very picky eating. One group will use cognitive-behavioral therapy (CBT-AR, a type of talk therapy) to change eating habits, while another group will receive nutrition counseling to learn about healthy eating. Children and teens aged 10-18 who have ARFID, can read and speak English, and don't have certain medical conditions might be suitable for this study. As an unphased trial, this study offers a unique opportunity for participants to contribute to understanding and improving treatments for ARFID.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

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

Studies have shown that cognitive-behavioral therapy for avoidant/restrictive food intake disorder (CBT-AR) is generally well-tolerated by children and teens. One study found that 55% of participants no longer met the criteria for the disorder by the end of treatment, suggesting that CBT-AR can be effective without causing serious side effects.

Nutrition counseling focuses on improving health and expanding food choices. This approach is safe, as it involves teaching and guiding participants toward better eating habits. Unlike medications, nutrition counseling does not cause side effects.

In summary, both CBT-AR and nutrition counseling are safe and well-tolerated options for those dealing with ARFID. They focus on changing behaviors and improving diet rather than using drugs.12345

Why are researchers excited about this trial?

Researchers are excited about these treatments for Avoidant/Restrictive Food Intake Disorder (ARFID) because they approach picky eating with innovative methods. Cognitive-Behavioral Therapy for ARFID (CBT-AR) is unique as it uses psychological techniques to change thought patterns and behaviors associated with food avoidance, potentially offering more lasting changes than traditional approaches like exposure therapy. On the other hand, Nutrition Counseling focuses on educating individuals about balanced diets and healthy eating habits, providing personalized guidance that could be more tailored than generic dietary advice. Both methods aim to address the root causes of ARFID in ways that are more personalized and potentially more effective than standard practices.

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

This trial will compare Cognitive-Behavioral Therapy for Avoidant/Restrictive Food Intake Disorder (CBT-AR) with Nutrition Counseling. Research has shown that CBT-AR is promising; one study indicated that 85% of patients were rated by their therapists as "much improved" or "very much improved." This therapy helps children and teens try new foods by addressing the reasons behind picky eating and using gradual exposure techniques.

In contrast, Nutrition Counseling, another treatment arm in this trial, focuses on improving overall health by filling nutritional gaps and expanding food choices. It aims to help children and adolescents overcome fears and worries about eating. Although direct data on the effectiveness of nutrition counseling is limited, it is a widely accepted method for managing ARFID.12678

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Current ARFID
Negative celiac screening panel indicating no active celiac disease as cause of symptoms
Fluency and literacy in English
See 1 more

Exclusion Criteria

Pregnancy, breastfeeding, or recent initiation/cessation of oral contraceptive pills within 8 weeks of the pre-treatment study visit
Current/history of psychosis
Medical instability requiring inpatient care according to the American Psychiatric Association 2023 treatment guidelines for eating disorders
See 10 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 15 weeks

15 weeks
Weekly sessions

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 Avoidant/Restrictive Food Intake Disorder (CBT-AR)
  • Nutrition Counseling for Avoidant/Restrictive Food Intake Disorder
Trial Overview 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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Nutrition CounselingExperimental Treatment1 Intervention
Group II: CBT-ARExperimental Treatment1 Intervention

Cognitive-Behavioral Therapy for Avoidant/Restrictive Food Intake Disorder (CBT-AR) is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as CBT-AR for:
🇪🇺
Approved in European Union as CBT-AR for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials
3,066
Recruited
13,430,000+

Published Research Related to This Trial

Cognitive-behavioral therapy for avoidant/restrictive food intake disorder (CBT-AR) was found to be acceptable and feasible for adults, with 93% of participants reporting high satisfaction after treatment.
The study showed significant improvements in ARFID severity, with 47% of participants no longer meeting the criteria for the disorder, and underweight individuals gaining an average of 11.38 pounds, indicating potential efficacy of CBT-AR.
Cognitive-behavioral therapy for adults with avoidant/restrictive food intake disorder.Thomas, JJ., Becker, KR., Breithaupt, L., et al.[2022]
A new 4-week exposure-based cognitive behavioral therapy (CBT) for adolescents with avoidant/restrictive food intake disorder (ARFID) showed promising results, with 10 out of 11 patients achieving remission and maintaining healthy body weight and nutritional intake at a 3-month follow-up.
The treatment led to significant reductions in food neophobia and levels of anxiety, suggesting that this CBT approach effectively addresses both the psychological and behavioral aspects of ARFID.
A new cognitive behavior therapy for adolescents with avoidant/restrictive food intake disorder in a day treatment setting: A clinical case series.Dumont, E., Jansen, A., Kroes, D., et al.[2021]
Cognitive-behavioral therapy for avoidant/restrictive food intake disorder (CBT-AR) was found to be feasible and acceptable, with 85% of participants rated as 'much improved' or 'very much improved' after treatment.
The treatment led to significant decreases in ARFID severity scores and an average weight gain of 11.5 pounds in the underweight subgroup, with 70% of patients no longer meeting the criteria for ARFID post-treatment.
Cognitive-behavioral therapy for avoidant/restrictive food intake disorder: Feasibility, acceptability, and proof-of-concept for children and adolescents.Thomas, JJ., Becker, KR., Kuhnle, MC., et al.[2021]

Citations

1.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/38213085/
Cognitive-behavioral therapy for avoidant/restrictive food ...Cognitive-behavioral therapy for avoidant/restrictive food intake disorder (ARFID; CBT-AR) theoretically targets three prototypic motivations.
Cognitive-behavioral therapy for avoidant/restrictive food ...Using intent-to-treat analyses, clinicians rated 17 patients (85%) as “much improved” or “very much improved.” ARFID severity scores (on the ...
Cognitive-behavioral therapy for adults with avoidant ...The purpose of this study was to evaluate the acceptability, feasibility, and proof-of-concept of cognitive-behavioral therapy for ARFID (CBT-AR) for adults.
Cognitive-Behavioral Therapy for Avoidant/Restrictive ...A groundbreaking cognitive-behavioral therapy approach for treating the often-overlooked eating disorder ARFID, with practical tools and case examples.
Cognitive‐behavioral therapy for avoidant/restrictive food ...Cognitive-behavioral therapy for ARFID (CBT-AR) uses an exposure-based approach to target the three prototypical motivations for ARFID currently ...
Cognitive Behavioral Therapy for Avoidant/Restrictive Food ...How does a limited diet keep ARFID going? Thomas, J.J. and Eddy, K.T. (2019). Cognitive-Behavioral Therapy for Avoidant/Restrictive Food Intake. Disorder: ...
An evaluation of Cognitive-Behavioral Therapy for ...The treatment was trialed in children and adolescents aged 10–17, finding that at the end of treatment 55 % of participants no longer met diagnostic criteria ...
8.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/32776570/
Cognitive-behavioral therapy for avoidant/restrictive food ...The purpose of this study was to evaluate feasibility, acceptability, and proof-of-concept for cognitive-behavioral therapy for ARFID (CBT-AR) in children and ...
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Terms of Service·Privacy Policy·Cookies·Security