Recruiting

BEST-U

Sponsor:

University of Kansas

Code:

NCT07060534

Conditions

Eating Disorders (Excluding Anorexia Nervosa)

Binge-Eating Disorder

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Building Healthy Eating and Self-Esteem Together for University Students

Present-Centered Therapy

Study Details

Brief summary:

Eating disorders (EDs) are a critical concern on college campuses. Moreover, since the COVID-19 pandemic, ED prevalence has increased by 62% in university women and 140% in university men. Resources are inadequate to meet demand, leading to delays in students' access to treatment. Untreated (or poorly treated) EDs result in greater healthcare utilization and costs to students, as well as lower academic achievement and increased psychiatric disability and mortality, suggesting a critical need for quality ED treatment on university campuses and to rethink treatment delivery. One way to address this gap in care delivery is to improve treatment accessibility and scalability, such as dissemination via mobile apps. Guided self-help Cognitive Behavior Therapy (CBT-gsh) is a cost-effective option that can be delivered by non-traditional service providers, such as nurses and physicians. Our scientific premise is that the mHealth CBT-gsh app, Building Healthy Eating and Self-Esteem Together for University Students (BEST-U), will lead to reductions in binge eating (primary outcome) through reductions in dietary restraint and weight/shape concerns (target mechanisms). Prior to implementing BEST-U at other universities, we need to test the intervention in a real-world setting with the end goal of disseminating at scale. Our objectives are to: 1) conduct an effectiveness test of BEST-U compared to a similar dose of present-centered therapy (PCT) in students with non-low weight binge-spectrum EDs and 2) test target mechanisms that lead to changes in binge eating. To accomplish our objectives, we will test the following specific aims: 1) conduct an RCT of BEST-U (N=37) compared to a similar dose of PCT (N=37) in students with non-low weight binge-spectrum EDs; 2) test target mechanisms that lead to changes in binge eating and other ED symptoms; and 3) characterize barriers and facilitators to implementation across two campuses. Our exploratory aim will test food reinforcement and food-choice impulsivity as potential target mechanisms or response moderators of rapid response in binge eating. Given that few studies have identified underlying mechanisms that explain how CBT-gsh works and for whom, this study may lead to improved ability to tailor or modify existing CBT-gsh or lead to novel intervention development for students who are unlikely to respond rapidly (or at all) to first line CBT interventions for EDs.

Conditions

Eating Disorders (Excluding Anorexia Nervosa)

Binge-Eating Disorder

Study ID

NCT07060534

Start date

Jun 23, 2026

Status verified date

Jun, 2025

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age ≥ 18 years.
  • Student enrolled at KU.
  • Bulimia nervosa (BN) or binge-eating disorder (BED) (or sub-threshold BN or BED).
  • Access to a smartphone.
  • No uncorrected vision problems that would interfere with ability to participate in the study.
  • Students taking psychotropic medications must be on a stable therapeutic dose for four weeks prior to study enrollment.
  • Able to read and speak fluent English.

Exclusion Criteria:

  • Presence of current moderate/severe suicidal ideation with active intent.
  • Significant psychopathology that could interfere with treatment (e.g., current substance-use disorder or psychosis).
  • Medical conditions or medications that could interfere with treatment (e.g., Type 1 diabetes mellitus, cancer, current pregnancy or nursing, taking corticosteroids, etc.).
  • Lab abnormalities indicating medical instability (e.g., low heart rate, electrolyte disturbance, acute medical complications of malnutrition) or another medical problem that would prevent outpatient care as determined through physical health assessment by the student's local clinician.
  • Already receiving therapy for an ED.
  • Positive screen for anorexia nervosa (AN), atypical AN (AAN), and/or low body weight (i.e., BMI < 19.5) or avoidant and restrictive food intake disorder (ARFID).

Study Design

Enrollment

74 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Present-Centered Therapy

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.

experimental: BEST-U 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).

Interventions

Building Healthy Eating and Self-Esteem Together for University Students

Building Healthy Eating and Self-Esteem Together for University Students (BEST-U) is an mHealth program that includes modules based on second- and third-wave behavior therapy deployed through a smart phone app paired with 20-30-minute coaching sessions. BEST-U incorporates a range of evidence-based skills, and the electronic format allows coaches immediate and easy access to participant reports. BEST-U provides a comprehensive all-in-one assessment and intervention package, is easy-to-implement, brief, and has been tested across genders and in diverse ages and ethnic groups. BEST-U, therefore, has the potential to deliver effective, time-limited, interventions applicable to all university students in routine student healthcare settings.

Present-Centered Therapy

Present-Centered Therapy (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. PCT was originally developed as a "placebo" intervention for post-traumatic stress disorder but is significantly more efficacious than wait-list in reducing psychiatric symptoms.

Primary outcome measure

  • Binge eating and total number of eating disorder symptoms measured through the Eating Pathology Symptoms Inventory [ Time Frame: Baseline, 12-week intervention (weekly), and 3- and 6-month follow-ups ]
  • BEST-U Daily Behavior Survey [ Time Frame: 12-week intervention (daily) ]

Central Contacts and Locations

Central contacts

Kelsie Forbush, PhD

785-864-6525kforbush@ku.edu

Kara Christensen-Pacella Assistant Professor, PhD

702-895-2279kara.christensen@unlv.edu

Locations

University of Kansas, Wakarusa Research Facility

Recruiting

Lawrence, Kansas, United States, 66045

Contacts

Alysia Martinez, BA

785-864-8830alysiaemartinez@ku.edu

Sierra Bilyeu, BA

785-864-8830sierrabilyeu@ku.edu

More Information

Sponsor

University of Kansas

Last update posted

Jan 14, 2026

Last verified

Jun, 2025

Keywords

  • Eating disorders
  • Bulimia nervosa
  • Binge-eating disorder
  • College Students
  • Purging disorder

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Kansas on 2026-01-14.