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Optimizing Digital Health Technology Interventions to Increase Skill Acquisition and Utilization
Optimizing Digital Health Technologies to Improve Therapeutic Skill Use and Acquisition
Who can join
Ages 18 to 65 · All sexes
Full eligibility criteria
Inclusion Criteria: 1. Are 18 to 65 years old. 2. Have experienced 12 or more loss of control episodes within the previous 3 months. 3. Have a BMI above 18.5. 4. Are located in the US and willing/able to participate in remote treatment and assessments. 5. Have a smartphone. 6. Complete the three-day app trial after the baseline assessment (i.e., the participant shows that they can self-monitor their episodes of eating three times a day for three days). Exclusion Criteria: 1. Are unable to fluently speak, write and read English. 2. Have a BMI below 18.5. 3. Are already receiving treatment for an eating disorder (e.g., research participants cannot be receiving concurrent eating disorder treatment in the clinical trial and from another provider). Participants willing to pause their existing eating disorder treatment for the duration of the clinical trial are eligible to participate. 4. Are already receiving pharmacological or behavioral treatment for weight loss. 5. If they meet the criteria for PCP clearance (see "Primary care physician clearance" section above) and are not deemed safe for outpatient treatment by a primary care physician. 6. If they meet the criteria for PCP clearance and are unwilling to receive medical clearance and/or medical monitoring as requested by the study to ensure they are medically safe to participate. 7. Have a mental handicap or are experiencing other severe psychopathology that would limit the research participants' ability to comply with the demands of the current study (e.g., imminent suicide risk, active psychotic disorder). Imminent suicide risk is assessed through the C-SSRS and a full risk assessment (see "Plan for assessing and/or intervening on suicidal ideation" above). Active psychotic disorder is assessed during the phone screen and with the standardized assessment checklist. 8. Are using a substance wherein the substance use is creating significant functional impairment that it is unlikely they can safely and effectively participate in an outpatient treatment study for eating pathology (i.e., the substance use: is interfering with day-to-day responsibilities and/or has gotten them in trouble with the law in the past year and/or has prevented them from attending/completing work and/or school within the past year) and/or if they are experiencing medical symptoms related to their substance use that requires immediate treatment and/or are unwilling or refrain from using the substances when it may interfere with treatment sessions and assessments (i.e., unwilling to not use the substances starting 2 hours prior to assessments and treatment sessions). Substance use is assessed during the phone screen and with the standardized assessment checklist. 9. Are pregnant or planning to become pregnant within the next year and a half.
About the study
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).
What is being tested
- Behavioral Therapy for Eating Disorders (behavioral)
- Skills Monitoring On (behavioral)
- Automated Reminder Messages (behavioral)
- JITAIs (behavioral)
Sponsor: Nemours Children's Clinic · Participants: 264 · Started: Jan 6, 2023
Contact the study team
- Adarsh Javvaji, B.A. · Phone: 302-433-1198
- Stephanie Manasse, Ph.D. · Phone: 302-333-0773
Official record on ClinicalTrials.gov — NCT05473013
Locations in the U.S.
| Delaware | Nemours Children's Health, Wilmington, Wilmington |
Conditions
From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.