Optimizing Digital Health Technology Interventions to Increase Skill Acquisition and Utilization
September 8, 2026 updated by: Stephanie Manasse, Nemours Children's Clinic
Optimizing Digital Health Technologies to Improve Therapeutic Skill Use and Acquisition
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).
Study Overview
Status
Recruiting
Conditions
Detailed Description
The current study will use a 2 x 3 full factorial design in which 264 individuals with BN or BED are assigned to one of six treatment conditions, i.e., representing each permutation of self-monitoring complexity (Skills-Monitoring On vs. Skills-Monitoring Off) and micro-intervention complexity (No Micro-Interventions vs. Automated Reminder Messages vs. JITAIs) as an augmentation to CBT. All participants will be given the gold-standard treatment for eating disorders known as cognitive behavioral therapy (CBT-E) which is the most evidence-based treatment to date for eating disorders and is a well-established treatment approach. The main innovation of the new proposed study is the evaluation of the efficacy of the six intervention conditions that arise as a result of testing each possible combination of self-monitoring complexity (Skills-Monitoring On vs. Skills-Monitoring Off) and micro-intervention complexity (No Micro-Interventions vs. Automated Reminder Messages vs. JITAIs) as an augmentation to CBT.
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).
Study Type
Interventional
Enrollment (Estimated)
264
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Adarsh Javvaji, B.A.
- Phone Number: 302-433-1198
- Email: projectacquire@nemours.org
Study Contact Backup
- Name: Stephanie Manasse, Ph.D.
- Phone Number: 302-333-0773
- Email: stephanie.manasse@nemours.org
Study Locations
-
-
Delaware
-
Wilmington, Delaware, United States, 19803
- Recruiting
- Nemours Children's Health, Wilmington
-
Contact:
- Clinical Research Coordinator
- Phone Number: 302-433-1198
- Email: projectacquire@nemours.org
-
Principal Investigator:
- Stephanie Manasse, Ph.D
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Are 18 to 65 years old.
- Have experienced 12 or more loss of control episodes within the previous 3 months.
- Have a BMI above 18.5.
- Are located in the US and willing/able to participate in remote treatment and assessments.
- Have a smartphone.
- 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:
- Are unable to fluently speak, write and read English.
- Have a BMI below 18.5.
- 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.
- Are already receiving pharmacological or behavioral treatment for weight loss.
- 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.
- 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.
- 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.
- 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.
- Are pregnant or planning to become pregnant within the next year and a half.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Base BT (Skills Monitoring Off + No Micro-Interventions)
16 weekly sessions of 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).
This will include traditional self-monitoring of participants' eating patterns, binging, and (if applicable) compensatory behaviors via a smartphone application.
|
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).
|
|
Experimental: Base BT + Skills Monitoring On + No Micro-Interventions
16 weekly sessions of 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).
This will include 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.
|
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).
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.
Other Names:
|
|
Experimental: Base BT + Skills Monitoring On + Automated Reminder Messages
16 weekly sessions of 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).This will include 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.
It will also include participants receiving two randomly time automated push notifications from the application each week to remind them about skills they have learned in session to encourage skill use.
|
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).
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.
Other Names:
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.
Other Names:
|
|
Experimental: Base BT + Skills Monitoring On + JITAIs
16 weekly sessions of 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).
This will include 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.
It will also include participants receiving push notifications each week to remind them 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).
|
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).
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.
Other Names:
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).
Other Names:
|
|
Experimental: Base BT + Skills Monitoring Off + Automated Reminder Messages
16 weekly sessions of 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).
This will include traditional self-monitoring of participants' eating patterns, binging, and (if applicable) compensatory behaviors via a smartphone application.
It will also include participants receiving two randomly time automated push notifications from the application each week to remind them about skills they have learned in session to encourage skill use.
|
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).
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.
Other Names:
|
|
Experimental: Base BT + Skills Monitoring Off + JITAIs
16 weekly sessions of 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).
This will include traditional self-monitoring of participants' eating patterns, binging, and (if applicable) compensatory behaviors via a smartphone application.
It will also include participants receiving push notifications each week to remind them 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).
|
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).
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).
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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 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
|
Changes from each assessment time point throughout treatment (3 assessments over 16 weeks) and at a 6 month follow-up assessment
|
|
Global Eating Pathology
Time Frame: Changes from each assessment time point throughout treatment (3 assessments over 16 weeks) and at a 6 month 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.
|
Changes from each assessment time point throughout treatment (3 assessments over 16 weeks) and at a 6 month follow-up assessment
|
|
Remission Status
Time Frame: Changes from each assessment time point throughout treatment (3 assessments over 16 weeks) and at a 6 month follow-up assessment
|
Presence or absence of eating disorder diagnosis.
Not in remission; in partial remission; or in full remission.
|
Changes from each assessment time point throughout treatment (3 assessments over 16 weeks) and at a 6 month follow-up assessment
|
|
BMI
Time Frame: Changes from each assessment time point throughout treatment (3 assessments over 16 weeks) and at a 6 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
|
Changes from each assessment time point throughout treatment (3 assessments over 16 weeks) and at a 6 month post-treatment follow-up assessment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Acceptability and Feasibility
Time Frame: Changes from each assessment time point throughout treatment after baseline so 2 assessments over 16 weeks (the mid-treatment and post-treatment assessments).
|
Perceived usefulness and ease-of-use of the technological components (the smartphone application) will be measured by the Technology Acceptance Model (TAM) Scales.
A Feedback Questionnaire will also be used to measure qualitative acceptability of both the technological components of the study and the treatment components.
Assessment of feasibility will include % of eligible patients enrolled, treatment attrition (% of patients that prematurely terminate treatment), and study retention (% of patients that complete all assessment points).
Data will also be collected on participants' use of CBT+ technological features, including time, duration, and frequency of use.
|
Changes from each assessment time point throughout treatment after baseline so 2 assessments over 16 weeks (the mid-treatment and post-treatment assessments).
|
|
Frequency of skill use and success of skill use
Time Frame: Changes from each weekly session over the course of the 16 week treatment
|
Data will be collected at each therapy session via a pre-session questionnaire for participants and post-session questionnaire for therapists to assess skills related to internal experiences such as urges and negative emotions that contribute to ED behaviors.
The items were adapted from the Difficulties in Emotional Regulation Scale (DERS).
|
Changes from each weekly session over the course of the 16 week treatment
|
|
Compensatory behavior frequency assessed by the Eating Disorder Examination (EDE)
Time Frame: Changes from each assessment time point throughout treatment (3 assessments over 16 weeks) and at a 6 month follow-up assessment
|
Frequency (number of days and number of instances) of compensatory behaviors assessed by the Eating Disorder Examination
|
Changes from each assessment time point throughout treatment (3 assessments over 16 weeks) and at a 6 month follow-up assessment
|
|
Emotional Self-regulation
Time Frame: Changes from each assessment time point throughout treatment (3 assessments over 16 weeks) and at a 6 month follow-up assessment
|
Changes in emotional self-regulation will be assessed using the total score of the Difficulties in Emotional Regulation Scale (DERS)
|
Changes from each assessment time point throughout treatment (3 assessments over 16 weeks) and at a 6 month follow-up assessment
|
|
Self-regulation: Impulsivity
Time Frame: Changes from each assessment time point throughout treatment (3 assessments over 16 weeks) and at a 6 month follow-up assessment
|
Changes in impulsivity will be assessed by the total score of the UPPS-P Impulsive Behaviors Scale.
|
Changes from each assessment time point throughout treatment (3 assessments over 16 weeks) and at a 6 month follow-up assessment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Stephanie Manasse, Ph.D., Nemours Children's Health
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 6, 2023
Primary Completion (Estimated)
January 1, 2027
Study Completion (Estimated)
January 1, 2027
Study Registration Dates
First Submitted
July 18, 2022
First Submitted That Met QC Criteria
July 21, 2022
First Posted (Actual)
July 25, 2022
Study Record Updates
Last Update Posted (Actual)
September 11, 2026
Last Update Submitted That Met QC Criteria
September 8, 2026
Last Verified
September 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2201009012
- R01MH129478 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
We will follow all guidelines for data sharing through the National Database for Clinical Trials Related to Mental Illness (NDCT) and the NIMH Data Archive (NDA).
All de-identified data will be submitted to the NDA at the item level and subject level.
IPD Sharing Time Frame
Within one year of project completion
IPD Sharing Access Criteria
We will include supporting documentation to allow other researchers to use this data easily and appropriately.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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