Building Healthy Eating and Self-Esteem Together for University Students

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity of Kansas

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

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

    Behavioral

    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

    Behavioral

    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.

Treatment groups

74 Participants
are divided into 2 treatment groups
Group A: Present-Centered TherapyExperimental treatment 1 intervention
Group B: BEST-U interventionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame
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

Time frame
12-week intervention (daily)

Secondary outcomes

1

Clinical Impairment Assessment

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

Time frame
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.

Time frame
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.

Time frame
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.

Time frame
Weeks 1-11

Other outcomes

1

Body Mass Index (BMI)

Ratio of weight to height

Time frame
Baseline, Weeks 1-12, and 3- and 6-month follow-ups
2

Quick SCID for DSM-5 Disorders

The QuickSCID is a brief, well-validated semi-structured clinical interview of DSM-5-TR disorders. The SCID will be administered to assess lifetime and current DSM-5-TR diagnoses at intake.

Time frame
Baseline
3

EPSI- Clinician Rated Version

The EPSI-Clinician Rated Version (EPSI-CRV) will be administered at intake to obtain a more nuanced assessment of current ED psychopathology.

Time frame
Baseline
4

World Health Organization Disability Assessment Schedule (WHODAS)

The WHODAS is a self-report questionnaire measuring general psychiatric impairment and functioning associated with DSM-5 diagnoses.

Time frame
Baseline, Week 12; 3-month follow-up; 6-month follow-up

Sponsors and contacts

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University of Kansas

Lead sponsor

National Institute of Mental Health (NIMH)

Collaborator