Therapy vs. Nutrition Counseling for Picky Eating

(COUNTERACT Trial)

Overseen By Jennifer J Thomas, PhD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: Psychosis, Substance use, Medical instability, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 15 weeks

50 Participants Needed

Trial Summary

What is the purpose of this trial?

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).

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.

What data supports the effectiveness of the treatment Cognitive-Behavioral Therapy for Avoidant/Restrictive Food Intake Disorder (CBT-AR)?

Research shows that Cognitive-Behavioral Therapy for ARFID (CBT-AR) is promising for both children and adults, with many patients reporting high satisfaction and significant improvements in their eating habits. In one study, adults who completed the therapy incorporated new foods into their diet and some even gained weight, moving from underweight to a healthier range. ^{1 2 3 4 5}

Is Cognitive-Behavioral Therapy for ARFID safe for humans?

The studies on Cognitive-Behavioral Therapy for Avoidant/Restrictive Food Intake Disorder (CBT-AR) in children, adolescents, and adults suggest that it is generally safe, with participants reporting high satisfaction and improvement in their condition. ^{1 2 3 4 5}

How is the treatment for picky eating using CBT-AR and Nutrition Counseling different from other treatments for ARFID?

This treatment is unique because it combines cognitive-behavioral therapy (CBT), which focuses on changing thought patterns and behaviors, with nutrition counseling to address avoidant/restrictive food intake disorder (ARFID). It specifically targets picky eating by using exposure-based techniques and inhibitory learning principles to help individuals gradually become more comfortable with a wider variety of foods. ^{1 2 3 5 6}

Eligibility Criteria

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

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

Timeline

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

Treatment Details

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.

Participant Groups

Group I: Nutrition Counseling Experimental Treatment 1 Intervention

Group II: CBT-AR Experimental Treatment 1 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:

• Avoidant/Restrictive Food Intake Disorder (ARFID) in children and adolescents

Approved in European Union as CBT-AR for:

• Avoidant/Restrictive Food Intake Disorder (ARFID) in children and adolescents

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Findings from Research

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

A case study of a 71-year-old male with Avoidant Restrictive Food Intake Disorder (ARFID) showed that after eight sessions of Cognitive Behavioral Therapy for ARFID (CBT-AR), he experienced significant reductions in ARFID symptoms and no longer met the diagnostic criteria for the disorder.

The patient also increased his oral food intake and successfully had his feeding tube removed, suggesting that CBT-AR may be an effective treatment option for older adults and those with feeding tubes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of avoidant-restrictive food intake disorder in an older adult: A proof-of-concept case study. Grunewald, W., Smith, AR., Brown, TA.[2023]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive-behavioral therapy for adults with avoidant/restrictive food intake disorder. Thomas, JJ., Becker, KR., Breithaupt, L., et al.[2022]

In a single case study of an adolescent male undergoing 21 sessions of cognitive-behavioral therapy for avoidant/restrictive food intake disorder (ARFID), significant reductions in food neophobia (45%) and ARFID severity (53-57%) were observed, with the patient no longer meeting ARFID criteria by the end of treatment.

The study suggests that the effectiveness of CBT for ARFID may be linked to the patient's motivation, as decreases in food neophobia were most pronounced when the patient incorporated foods related to his treatment goals, indicating a potential mechanism for how CBT-AR works.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Food neophobia as a mechanism of change in video-delivered cognitive-behavioral therapy for avoidant/restrictive food intake disorder: A case study. Burton Murray, H., Becker, KR., Breithaupt, L., et al.[2023]

Individuals with Avoidant/Restrictive Food Intake Disorder (ARFID) experience higher levels of distress and impairment compared to typical eaters and picky eaters without ARFID, showing comparable levels to those with anorexia and bulimia symptoms.

Distinct eating behaviors, such as food neophobia and inflexible eating patterns, effectively differentiate picky eaters with ARFID from those without ARFID, highlighting that ARFID symptoms are unique and associated with significant internal distress.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adult picky eaters with symptoms of avoidant/restrictive food intake disorder: comparable distress and comorbidity but different eating behaviors compared to those with disordered eating symptoms. Zickgraf, HF., Franklin, ME., Rozin, P.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Cognitive-behavioral therapy for avoidant/restrictive food intake disorder: Feasibility, acceptability, and proof-of-concept for children and adolescents. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

A new cognitive behavior therapy for adolescents with avoidant/restrictive food intake disorder in a day treatment setting: A clinical case series. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Treatment of avoidant-restrictive food intake disorder in an older adult: A proof-of-concept case study. [2023]

4. France pubmed.ncbi.nlm.nih.gov

Cognitive-behavioral therapy for adults with avoidant/restrictive food intake disorder. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Food neophobia as a mechanism of change in video-delivered cognitive-behavioral therapy for avoidant/restrictive food intake disorder: A case study. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Adult picky eaters with symptoms of avoidant/restrictive food intake disorder: comparable distress and comorbidity but different eating behaviors compared to those with disordered eating symptoms. [2022]