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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
264

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Delaware
      • Wilmington, Delaware, United States, 19803
        • Recruiting
        • Nemours Children's Health, Wilmington
        • Contact:
        • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
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).
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.
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.
Other Names:
  • Enhanced Skills Monitoring
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.
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.
Other Names:
  • Enhanced Skills Monitoring
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.
Other Names:
  • Micro-Intervention 1
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).
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.
Other Names:
  • Enhanced Skills Monitoring
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).
Other Names:
  • Micro-Intervention 2
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.
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: 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.
Other Names:
  • Micro-Intervention 1
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).
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: 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).
Other Names:
  • Micro-Intervention 2

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nemours Children's Clinic

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Mental Health (NIMH)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 6, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 18, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 21, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 25, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 11, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 8, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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