BEST-U App for Binge Eating Disorder

(BEST-U Trial)

Overseen By Kelsie Forbush, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Kansas

Must be taking: Psychotropics

Must not be taking: Corticosteroids

Disqualifiers: Suicidal ideation, Substance-use, Psychosis, others

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

Compensation: Varies

Number of Visits: 14

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a mobile app designed to assist university students with binge eating disorders. The aim is to determine if this app, called Building Healthy Eating and Self-Esteem Together for University Students, can reduce binge eating by helping users manage their eating habits and body image concerns. Participants will either use the app or receive present-centered therapy, which addresses daily stressors. Ideal candidates are KU students with bulimia nervosa or binge-eating disorder who have access to a smartphone and are not currently receiving therapy for an eating disorder. As an unphased trial, this study offers students the chance to contribute to innovative research that could enhance mental health support for their peers.

Will I have to stop taking my current medications?

If you are taking psychotropic medications, you need to be on a stable dose for at least four weeks before joining the study. However, if you are taking medications that could interfere with the treatment, like corticosteroids, you may need to stop them.

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

Research has shown that the BEST-U app for university students is designed to be safe. Early studies examined its development, usability, and user satisfaction. These studies primarily assess whether the app is easy and satisfying to use, ensuring it doesn't introduce new risks. The app employs guided self-help techniques based on cognitive behavioral therapy (CBT), which most users find manageable.

The other treatment under evaluation is Present-Centered Therapy (PCT), which has demonstrated positive outcomes in past research. It aids in managing daily stress, potentially reducing binge-eating. Studies have found that participants are generally very satisfied with this therapy, and it is considered safe.

Both treatments use non-invasive methods, such as therapy sessions and app interactions, which are typically low-risk. For those considering joining the trial, these findings suggest a focus on safety and effectiveness in managing binge-eating symptoms. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for Binge Eating Disorder (BED) because they offer innovative approaches compared to traditional therapies like Cognitive Behavioral Therapy (CBT) or medication. The BEST-U intervention stands out due to its digital self-help format specifically tailored for university students, combining principles from CBT, CBT-Enhanced (CBT-E), and Dialectical Behavior Therapy (DBT) into brief, interactive modules. This approach allows users to engage in therapy at their own pace, reinforced by weekly telehealth coaching sessions. Meanwhile, Present-Centered Therapy (PCT) offers a novel focus on resolving interpersonal issues and daily stressors, which are often overlooked triggers for BED. These treatments aim to provide more accessible, personalized, and comprehensive care for individuals struggling with BED.

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

Research shows that the BEST-U app, a treatment in this trial, uses guided self-help Cognitive Behavioral Therapy (CBT-gsh) to reduce binge eating. This therapy helps individuals change negative thoughts and behaviors that lead to eating disorders. Studies suggest that the app can lower binge eating by reducing strict dieting and concerns about weight and body shape.

Present-Centered Therapy (PCT) is another treatment option in this trial, focusing on managing life stress that can trigger binge eating. Research has found that PCT effectively reduces binge-eating symptoms, with many participants showing improvement over time. Both treatments in this trial aim to help individuals develop healthier eating habits and manage stress, offering promising options for those struggling with binge eating. ^{1 2 3 4 6}

Who Is on the Research Team?

Kelsie Forbush, PhD

Principal Investigator

University of Kansas

Are You a Good Fit for This Trial?

This trial is for university students with non-low weight binge-spectrum eating disorders. It's designed to help those who have seen an increase in such issues since the COVID-19 pandemic and are struggling to find accessible treatment.

Inclusion Criteria

Able to read and speak fluent English

Student enrolled at KU

Access to a smartphone

Exclusion Criteria

I do not have any health conditions or take medications that could affect the treatment.

I am currently receiving treatment for an eating disorder.

Presence of current moderate/severe suicidal ideation with active intent

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the BEST-U intervention, consisting of 15 brief modules delivered weekly over 12 sessions, with weekly 25-30 minute telehealth coaching sessions.

12 weeks

12 visits (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 3- and 6-month intervals.

6 months

2 visits (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Building Healthy Eating and Self-Esteem Together for University Students
• Present-Centered Therapy

Trial Overview The study compares a mobile app-based Cognitive Behavior Therapy (CBT-gsh) called BEST-U, aimed at reducing binge eating by addressing dietary restraint and body concerns, against present-centered therapy (PCT), which focuses on current life situations.

How Is the Trial Designed?

Group I: Present-Centered Therapy Experimental Treatment 1 Intervention

PCT is a brief intervention that focuses on building adaptive responses to current life stressors that are directly or indirectly related to psychopathology. PCT focuses on resolving interpersonal disconnection through the development of a positive therapeutic relationship, encouraging connection with others, and addressing interpersonal concerns. We chose PCT as a comparator because it targets daily life stressors, which are important triggers of negative emotions and emotion dysregulation that lead to binge-eating and other eating-disorder symptoms.

Group II: BEST-U intervention Experimental Treatment 1 Intervention

Building Healthy Eating and Self-Esteem Together for University Students (BEST-U) is a transdiagnostic guided self-help ED treatment for adults that uses evidence-based principles to modify unhelpful thoughts and behaviors that maintain ED and trauma-related psychopathology. The program consists of 15 brief modules delivered each week over 12 sessions. Modules take approximately 10 minutes to complete and focus on key information/lessons that are short and interactive. BEST-U leverages frequent assessment to increase awareness of, and target, problem behaviors. Users reinforce their learning through weekly 25-30-minute telehealth "coaching" sessions, to review module material, problem-solve, practice skills, and plan homework exercises. BEST-U modules and coaching sessions utilize lessons and exercises drawn from Cognitive Behavioral Therapy Enhanced (CBT-E), traditional Cognitive Behavioral Therapy (CBT), and Dialectical Behavior Therapy (DBT).

Who Is Running the Clinical Trial?

University of Kansas

Lead Sponsor

Trials

157

Recruited

332,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10372766/

The Building Healthy Eating and Self-Esteem Together for ... This paper describes the development, usability, and acceptability of the Building Healthy Eating and Self-Esteem Together for University Students (BEST-U) ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07060534

Building Healthy Eating and Self-Esteem Together for ... Our hypothesis is that the mHealth CBT-gsh app, BEST-U, will lead to reductions in binge eating (primary outcome) through reductions in dietary restraint, ...

3. researchgate.net researchgate.net/publication/370112805_The_Building_Healthy_Eating_and_Self-Esteem_Together_for_University_Students_BEST-U_Mobile_App_to_Treat_Eating_Disorders_in_University_Students_User-Centered_Research_Design_and_Feasibility_Study_Prep

(PDF) The Building Healthy Eating and Self-Esteem ... Objective: This paper describes the development, usability, and acceptability of the Building Healthy Eating and Self-Esteem Together for University Students ( ...

4. scholarlyexchange.childrensmercy.org scholarlyexchange.childrensmercy.org/papers/5296/

"The Building Healthy Eating and Self-Esteem Together for ... OBJECTIVE: This paper describes the development, usability, and acceptability of the Building Healthy Eating and Self-Esteem Together for ...

5. msesiom.demo.elsevierpure.com msesiom.demo.elsevierpure.com/es/projects/building-healthy-eating-and-self-esteem-together-for-university-s

Building Healthy Eating and Self-Esteem Together for ... Healthy Eating and Self-Esteem Together for University Students (BEST-U), will lead to reductions in binge eating (primary outcome) through ...

6. withpower.com withpower.com/trial/phase-feeding-and-eating-disorders-7-2025-1e28f

BEST-U App for Binge Eating Disorder · Info for Participants This trial is for university students with non-low weight binge-spectrum eating disorders. It's designed to help those who have seen an increase in such issues ...