[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100597595":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":29,"centralContacts":33,"locations":42,"responsibleParty":65,"collaborators":67,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":22,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":73,"sex":78,"minAge":79,"maxAge":80,"enrollmentInfo":81,"targetDuration":25,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":91,"overallStatus":45,"whyStopped":25,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"University of Kansas","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Present-Centered Therapy","EXPERIMENTAL","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.",[13],"Behavioral: Present-Centered Therapy",{"label":15,"type":10,"description":16,"interventionNames":17},"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\u002Flessons 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).",[18],"Behavioral: Building Healthy Eating and Self-Esteem Together for University Students",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"BEHAVIORAL","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.",[15],null,{"type":21,"name":9,"description":27,"armGroupLabels":28,"otherNames":25},"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.",[9],[30],{"name":31,"affiliation":5,"role":32},"Kelsie Forbush, PhD","PRINCIPAL_INVESTIGATOR",[34,38],{"name":31,"role":35,"phone":36,"phoneExt":25,"email":37},"CONTACT","785-864-6525","kforbush@ku.edu",{"name":39,"role":35,"phone":40,"phoneExt":25,"email":41},"Kara Christensen-Pacella Assistant Professor, PhD","702-895-2279","kara.christensen@unlv.edu",[43],{"facility":44,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"University of Kansas, Wakarusa Research Facility","RECRUITING","Lawrence","Kansas","66045","United States","US",{"type":52,"coordinates":53},"Point",[54,55],-95.23525,38.97167,{"lat":55,"lon":54},[58,62],{"name":59,"role":35,"phone":60,"phoneExt":25,"email":61},"Alysia Martinez, BA","785-864-8830","alysiaemartinez@ku.edu",{"name":63,"role":35,"phone":60,"phoneExt":25,"email":64},"Sierra Bilyeu, BA","sierrabilyeu@ku.edu",{"type":66,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[68],{"name":69,"class":70},"National Institute of Mental Health (NIMH)","NIH","100597595","building-healthy-eating-and-self-esteem-together-for-university-students-100597595",false,"NCT07060534","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","BEST-U","Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Student enrolled at KU.\n* Bulimia nervosa (BN) or binge-eating disorder (BED) (or sub-threshold BN or BED).\n* Access to a smartphone.\n* No uncorrected vision problems that would interfere with ability to participate in the study.\n* Students taking psychotropic medications must be on a stable therapeutic dose for four weeks prior to study enrollment.\n* Able to read and speak fluent English.\n\nExclusion Criteria:\n\n* Presence of current moderate\u002Fsevere suicidal ideation with active intent.\n* Significant psychopathology that could interfere with treatment (e.g., current substance-use disorder or psychosis).\n* Medical conditions or medications that could interfere with treatment (e.g., Type 1 diabetes mellitus, cancer, current pregnancy or nursing, taking corticosteroids, etc.).\n* 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.\n* Already receiving therapy for an ED.\n* Positive screen for anorexia nervosa (AN), atypical AN (AAN), and\u002For low body weight (i.e., BMI \\\u003C 19.5) or avoidant and restrictive food intake disorder (ARFID).","ALL","18 Years","65 Years",{"count":82,"type":83},74,"ESTIMATED","INTERVENTIONAL",[86],"NA","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\u002Fshape 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.",[89,90],"Eating Disorders (Excluding Anorexia Nervosa)","Binge-Eating Disorder",[92,93,94,95,96],"Eating disorders","Bulimia nervosa","Binge-eating disorder","College Students","Purging disorder","2026-01-13",{"date":99,"type":100},"2026-01-14","ACTUAL",{"date":102,"type":83},"2026-06-23",{"date":104,"type":83},"2027-12-31",{"name":5,"class":6},1]