NCT05473013 · Nemours Children's Clinic
Optimizing Digital Health Technology Interventions to Increase Skill Acquisition and Utilization
What this study is about
The purpose of this study is to identify the independent and combined effects of two types of self-monitoring and two types of micro-interventions when combined with standard cognitive behavioral treatment for bulimia nervosa (BN) and binge eating disorder (BED).
View original scientific description
The purpose of this study is to identify the independent and combined effects of two types of self-monitoring and two types of micro-interventions when combined with standard cognitive behavioral treatment for bulimia nervosa (BN) and binge eating disorder (BED). The primary aims of this study are (1) to evaluate the optimal complexity of Self-Monitoring and Micro-Interventions on eating pathology (at post-treatment and at 6 and 12-month follow-ups and (2) to test the hypotheses that the optimal complexity level of each component is moderated by baseline deficits in self-regulation. The secondary aim will be to test target engagement for each level of complexity for each component, i.e., to test whether higher complexity of each technological components is associated with better rates of therapeutic skill use and acquisition and that improvements in skill use and acquisition are associated with improvements in outcomes. A final exploratory aim will be to quantify the component interaction effects, which may be partially additive (because components overlap and/or there is diminishing return), fully additive, or synergistic (in that component complexities may partially depend on each other).
Interventions
BEHAVIORAL
Behavioral Therapy for Eating Disorders
Standard behavioral therapy for eating disorders aimed at changing behaviors that maintain binge eating (e.g. rigid dietary restriction outside of binge episodes, irregular or chaotic eating patterns).
BEHAVIORAL
Skills Monitoring On
Integrates behavioral treatment for eating disorders with a more complex self-monitoring than the self-monitoring protocol with traditional behavioral treatment. Via a smartphone application, participants will be asked to self-monitor skill usage of the skills provided during treatment sessions on top of monitoring their eating patterns, binging, and (if applicable) compensatory behaviors.
BEHAVIORAL
Automated Reminder Messages
Integrates behavioral treatment for eating disorders with two randomly time automated push notifications from a smartphone application each week to remind participants about skills they have learned in session to encourage skill use.
BEHAVIORAL
JITAIs
Integrates behavioral treatment for eating disorders with push notifications each week from a smartphone application to remind participants about skills they have learned in session to encourage skill use during app-identified moments of need (i.e., JITAIs, just-in-time adaptive interventions).
Primary outcome measures
Binge eating frequency assessed by the Eating Disorder Examination
Time frame: Changes from each assessment time point throughout treatment (3 assessments over 16 weeks) and at a 6 month and a 12-month post-treatment follow-up assessment
Frequency (number of days and number of instances) of binge eating over the past 28 days assessed by the Eating Disorder Examination
Global Eating Pathology
Time frame: Changes from each assessment time point throughout treatment (3 assessments over 16 weeks) and at a 6 month and a 12-month post-treatment follow-up assessment
The Eating Disorder Examination is a semi-structured interview that measures eating. pathology. The EDE yields a total eating pathology score that will be used as an outcome variable. Global eating pathology is on a 0-6 point scale with higher scores indicating more significant eating pathology.
Remission Status
Time frame: Changes from each assessment time point throughout treatment (3 assessments over 16 weeks) and at a 6 month and a 12-month post-treatment follow-up assessment
Presence or absence of eating disorder diagnosis. Not in remission; in partial remission; or in full remission.
BMI
Time frame: Changes from each assessment time point throughout treatment (3 assessments over 16 weeks) and at a 6 month and a 12-month post-treatment follow-up assessment
kilogram/(meters\^2), this will be calculated by assessors when participants provide their height and weight at all assessment points
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Have experienced 12 or more loss of control episodes within the previous 3 months
- Have a BMI at or above 18.5
- Are located in the US and willing/able to participate in treatment and assessments
- Are able to give consent
Exclusion criteria
- Are unable to fluently speak, write and read English
- Have a BMI below 18.5
- Are already receiving treatment for an eating disorder
- Require immediate treatment for medical complications as a result of eating disorder symptoms
- Have a mental handicap, or are experiencing other severe psychopathology that would limit the participants' ability to comply with the demands of the current study (e.g. severe depression with suicidal intent, active psychotic disorder, severe substance use)
- Are pregnant or are planning to become pregnant
Where
- Philadelphia, Pennsylvania
Collaborators
National Institute of Mental Health (NIMH)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 19, 2026 · Source of record for eligibility and locations