Cognitive-Behavioral Therapy for Binge Eating

(CARE2 Trial)

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 treatments for adolescents who frequently binge eat and are above the 85th percentile for their age and sex in weight. The treatments compared are cognitive-behavioral therapy (CBT), a type of talk therapy, and a lifestyle program focusing on healthy habits. A control group tracks their eating and mood using an app. The aim is to determine which method best reduces binge eating and aids in weight management. Teens who have experienced at least four binge-eating episodes per month over the last three months may be suitable for this study. As an unphased trial, this study offers a unique opportunity to contribute to understanding effective treatments for binge eating in adolescents.

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

Studies have shown that cognitive-behavioral therapy (CBT) is safe and effective for treating binge eating in teenagers. Research indicates that CBT reduces binge-eating episodes and is generally well-tolerated, with no major side effects reported. This makes it a reliable option for many teens facing this issue.

For the lifestyle behavioral obesity intervention (LBOI), research suggests it is also safe and helps teenagers manage their weight and improve eating habits. A recent review found that these programs do not increase the risk of eating disorders and may even reduce binge-eating symptoms. This intervention is considered a first-choice treatment for teenagers dealing with obesity and related challenges.

Both CBT and LBOI provide supportive and structured ways to address binge eating and obesity, with a strong safety record.12345

Why are researchers excited about this trial?

Researchers are excited about these treatments for adolescent binge eating because they offer innovative approaches that differ from traditional methods. Cognitive-Behavioral Therapy (CBT-BED) and Lifestyle Behavioral Obesity Intervention (LBOI) are both delivered remotely via telehealth, making them more accessible to teens who might struggle with in-person visits. While CBT-BED focuses on identifying and changing negative thought patterns associated with binge eating, LBOI emphasizes lifestyle changes to manage weight and eating habits. The use of telehealth also allows for greater flexibility and convenience, potentially increasing adherence and effectiveness compared to standard in-person therapy sessions.

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

Research has shown that cognitive-behavioral therapy (CBT), one of the treatments in this trial, can help reduce binge eating in teenagers. Studies have found that CBT leads to fewer binge eating episodes and better eating habits. For instance, one study reported that CBT resulted in a decrease in binge eating and improved overall eating behavior.

In contrast, the lifestyle behavioral obesity intervention (LBOI), another treatment option in this trial, effectively promotes weight loss. These programs focus on healthy eating and exercise and have demonstrated significant weight loss compared to no intervention. However, LBOI generally does not reduce binge eating as effectively as CBT.16789

Are You a Good Fit for This Trial?

This trial is for adolescents who struggle with binge eating and are overweight or have obesity. Participants must be able to join remotely from most states in the U.S. The study is not for those without these eating or weight concerns.

Inclusion Criteria

I am between 12 and 17 years old.
My BMI is above the 85th percentile for my age and sex.
Report 4 episodes of binge eating per month for the past 3 months
See 1 more

Exclusion Criteria

I am taking medication or treatment that affects my weight or appetite.
I started using hormonal birth control less than 3 months ago.
Have a medical or psychiatric condition prohibiting engagement in behavioral treatment or moderate physical activity (e.g., cardiovascular problems)
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either CBT-BED, LBOI, or engage in Active Control self-monitoring for 6 months

6 months
Remote participation via telehealth

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 Adolescent Binge Eating
  • Lifestyle Behavioral Obesity Intervention

Trial Overview

The study compares two online treatments: cognitive-behavioral therapy (CBT) focused on binge eating, and a lifestyle program aimed at healthy habits and weight loss. There's also a control group using an app to track food intake and mood.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Active Control

Group I: Lifestyle Behavioral Obesity InterventionExperimental Treatment1 Intervention
Group II: Cognitive-Behavioral TherapyExperimental Treatment1 Intervention
Group III: Active ControlActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials
1,063
Recruited
1,182,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials
2,513
Recruited
4,366,000+

Citations

Eating Disorder Hotlines for Crisis Help

There are several eating disorder hotlines you can call if you or someone you know needs help with an eating disorder.

Effectiveness of a Web-Based Cognitive Behavioral Self ...

The web-based intervention led to significant improvements in binge eating episodes (Cohen d, −0.79 [95% CI, −1.17 to −0.42]; P < .001), ...

Cognitive behavioral therapy for eating disorders - PMC - NIH

High intensity CBT was more effective compared to mixed active controls in reducing ED behaviors and psychopathology (see Table 3). It was also ...

A systematic review of cognitive behavior therapy and ...

By the end of treatment, patients reported significant improvements in global eating disorder psychopathology, binge eating, and vomiting, and ...

NCT04088097 Cognitive Behavioral Therapy for ...

Cognitive-behavioral therapy (CBT) has a strong evidence base for adult BED (20-25). is unclear (30- 34). parental involvement improves weight outcomes (29, 36 ...

Cognitive-behavioral therapy for binge eating disorder in ...

BED has been identified in 1.6% of 13- to 18-year-old adolescents from the community [3], and in up to 25% of treatment-seeking adolescents

NCT04088097 Cognitive Behavioral Therapy for ...

A cognitive-behavioral adaptation for adolescents with recurrent binge eating (with or without purging) had a small sample and used a delayed-treatment control ...

Behavioral Therapy for Eating Disorders in Children & ...

CBT may help adolescents or younger children cope with issues that trigger binge-eating episodes, such as negative feelings about the body or a depressed mood.

Enhanced Cognitive Behavioral Therapy (CBT-E) for ...

Current guidelines inform that CBT-E is the most appropriate alternative to FBT for adolescents with anorexia nervosa or bulimia nervosa.