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Eating Disorders (Excluding Anorexia Nervosa)BEST-UNCT07060534

Building Healthy Eating and Self-Esteem Together for University Students

A study testing Building Healthy Eating and Self-Esteem Together for University Students and Present-Centered Therapy in people with Eating Disorders (Excluding Anorexia Nervosa) and Binge-Eating Disorder, run by University of Kansas at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
Building Healthy Eating and Self-Esteem Together for University Students and Present-Centered Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
74 participants
Where
1 siteUnited States
Study dates
23 Jun 2026to 31 Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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).

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Kelsie Forbush, PhD contact

785-864-6525

kforbush@ku.edu

Kara Christensen-Pacella Assistant Professor, PhD contact

702-895-2279

kara.christensen@unlv.edu

United States1 site, 1 recruiting
  • University of Kansas, Wakarusa Research Facility

    Lawrence, Kansas, 66045

    Alysia Martinez, BA, 785-864-8830, alysiaemartinez@ku.edu

    Sierra Bilyeu, BA, 785-864-8830, sierrabilyeu@ku.edu

    Recruiting

Other trials in United States

About this study

Official title: Building Healthy Eating and Self-Esteem Together for University Students (BEST-U): A Pilot Randomized Controlled Trial of an mHealth Intervention for Binge-Spectrum Disorders

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.

Read the detailed description

Eating disorders (EDs) are a critical concern on college campuses and the COVID-19 pandemic has led to increased ED prevalence of 62% in university women and 140% in university men. Resources are inadequate to meet this rising demand as student counseling centers are often understaffed and only 20-21.9% of students reported receiving care for their eating problems, due to financial, logistical, and psychological barriers to accessing treatment. Unfortunately, even when students receive treatment, only a fraction of providers use evidence-based strategies. 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 for rethinking modes of treatment delivery.

One way to address this gap in care delivery is to improve accessibility and scalability of treatment options, such as delivering care via mobile apps. Guided self-help Cognitive-Behavior Therapy (CBT-gsh) is a cost-effective option that can be delivered by a range of non-traditional service providers, such as nurses and physicians. Existing mobile health (mHealth) CBT-gsh programs do not include critical components of CBT such as food and symptom monitoring and reinstatement of regular eating patterns and have limitations that yield low engagement. Our team has developed an easy to use mHealth CBT-gsh program incorporating evidence-based for college students named Building Healthy Eating and Self-Esteem Together for University Students (BEST-U)that includes modules 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 young adults in routine student healthcare settings.

Beyond knowing that CBT-gsh interventions are effective generally, it is critical to know how such interventions work and for whom. Without this data, it will remain difficult to: 1) determine what components to add to improve efficacy and 2) identify which clients will respond and which should be referred to alternative care. Thus, novel and scalable treatments to test underlying mechanisms are urgently needed in this population.

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, weight/shape concerns (targets), and negative emotions. Our pilot data showed strong support for our premise, specifically the need for brief, targeted mHealth interventions in students and the ability of the program to significantly reduce binge eating and impairment and increase wellbeing, with high user acceptability and low drop-out rates. Importantly, these treatment gains were maintained at 3- and 6-month follow-up. However, 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. Thus, we will: 1) conduct an effectiveness test of BEST-U (N=37) compared to a similar dose of present-centered therapy (PCT; N=37) in students with non-low weight binge-spectrum EDs; 2) test target mechanisms that lead to changes in binge eating; and 3) characterize barriers and facilitators to implementing such an intervention across two college campuses.

In addition to our core hypotheses, our exploratory aim is to test food reinforcement and food-choice impulsivity as target mechanisms or response moderators of rapid response in binge eating. Rapid change in binge eating during the first four weeks of CBT-based ED interventions (i.e., "rapid response") is associated with improved end-of-treatment outcomes and aligns temporally with the introduction of "regular eating," a key element for reducing dietary restraint and, thereby, risk for binge eating. However, it is unknown why some individuals respond rapidly to normalization in eating patterns by reducing or eliminating binge eating and why binge eating persists for others. We posit that changes in the relative reinforcement value of food will predict, and food-choice impulsivity will moderate, these differential responses.

Being tested
Building Healthy Eating and Self-Esteem Together for University Students, Present-Centered Therapy
Keywords
Eating disorders, Bulimia nervosa, Binge-eating disorder, College Students, Purging disorder
Medical subject headings
Feeding and Eating Disorders, Binge-Eating Disorder, Bulimia Nervosa

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Building Healthy Eating and Self-Esteem Together for University StudentsBehavioural

    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 TherapyBehavioural

    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.

Study groups in NCT07060534
Study groupRoleWhat they receive
Present-Centered TherapyExperimentalPCT 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.
Receives: Behavioral: Present-Centered Therapy
BEST-U interventionExperimentalBuilding 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).
Receives: Behavioral: Building Healthy Eating and Self-Esteem Together for University Students

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Binge eating and total number of eating disorder symptoms measured through the Eating Pathology Symptoms Inventory

    The EPSI is a well-validated self-report questionnaire measuring disordered eating symptoms appropriate for use across the weight spectrum and across several demographic groups.

    Measured: Baseline, 12-week intervention (weekly), and 3- and 6-month follow-ups

  2. BEST-U Daily Behavior Survey

    Includes self-report of number of daily behaviors, such as binge eating episodes and meal skipping

    Measured: 12-week intervention (daily)

Secondary outcomes (4)
  1. Clinical Impairment Assessment

    The Clinical Impairment Assessment is a self-report questionnaire and measures psychosocial impairment secondary to disordered eating concerns.

    Measured: Baseline, Week 12, and 3- and 6-month follow-ups

  2. GAD-7

    The GAD-7 scale is a 7-item questionnaire that assesses how a client has been impacted by symptoms of anxiety over the past two weeks.

    Measured: Intake, Week 12, 3-month, 6-month follow up.

  3. PHQ-9

    The Patient Health Questionnaire (PHQ-9) is a nine-item scale used to assess depressive symptoms occurring over the past two weeks in adults.

    Measured: Intake, Week 12, 3-month follow up, 6-month follow up.

  4. IDAS-II Dysphoria

    The IDAS-II Dysphoria scale has been shown to correlate strongly with DSM diagnoses of depression (d>1.00), but also has medium to large effect sizes for correlations with panic disorder, posttraumatic stress disorder, and generalized anxiety disorder. Dysphoria also significantly predicts diagnoses of major depression, panic disorder, and generalized anxiety disorder. Assessing Dysphoria on a weekly basis will, therefore, allow us to determine whether changes in negative emotion precede changes in outcomes.

    Measured: Weeks 1-11

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jul 2025
  2. Study start23 Jun 2026 (estimated)
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
74 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07060534
Sponsor's protocol ID
STUDY00144380
Other IDs
R34MH134930-01A1
Acronym
BEST-U
Status last verified
Jun 2025
First submitted
24 Jun 2025
Last updated
14 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Per NIMH requirements, we will share data from the proposed project using the NDA. Data from this project will be preserved to enable sharing through the NDA to validate and replicate the research findings described in our Specific Aims. Data sharing will also enable independent investigators to conduct secondary analyses. Participants will be apprised of how their data will be shared during the consent process. We are committed to sharing research data in a way that is consistent with applicable law and policy, agency mission, and USA national, homeland, and economic security. De-identified data collected from this study will be made publicly available on the NIMH Data Archive. We will restrict any data that may reveal subjects' identities (e.g., geographical location). We view data sharing as crucial for advancing science in eating disorder (ED) research, particularly given that there are few treatment studies of CBT-gsh in young adults.

Questions about this trial

What is this clinical trial studying?

A study testing Building Healthy Eating and Self-Esteem Together for University Students and Present-Centered Therapy in people with Eating Disorders (Excluding Anorexia Nervosa) and Binge-Eating Disorder, run by University of Kansas at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 14 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Kelsie Forbush, PhD (785-864-6525, kforbush@ku.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2026.

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