Bulimia NervosaNCT05473013
Optimizing Digital Health Technology Interventions to Increase Skill Acquisition and Utilization
A study testing Behavioral Therapy for Eating Disorders, Skills Monitoring On and Automated Reminder Messages in people with Bulimia Nervosa and Bulimia, run by Nemours Children's Clinic at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bulimia Nervosa, Bulimia, Binge Eating
- What is being tested?
- Behavioral Therapy for Eating Disorders, Skills Monitoring On and Automated Reminder Messages
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 264 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jan 2023to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Nemours Children's Health, Wilmington
Wilmington, Delaware, 19803
Clinical Research Coordinator, 302-433-1198, projectacquire@nemours.org
Stephanie Manasse, Ph.D
About this study
Official title: 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).
Read the 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).
- Conditions
- Bulimia Nervosa, Bulimia, Binge Eating, Binge-Eating Disorder
- Being tested
- Behavioral Therapy for Eating Disorders, Skills Monitoring On, Automated Reminder Messages, JITAIs
- Keywords
- Eating disorders, Bulimia Nervosa, Bulimia, Binge Eating, Binge Eating Disorder, Cognitive Behavioral Treatment for Eating Disorders, Digital health technologies (DHTs), Micro-Interventions
- Medical subject headings
- Bulimia Nervosa, Bulimia, Binge-Eating Disorder, Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral Therapy for Eating DisordersBehavioural
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).
Skills Monitoring OnBehavioural
Also called Enhanced Skills Monitoring
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.
Automated Reminder MessagesBehavioural
Also called Micro-Intervention 1
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.
JITAIsBehavioural
Also called Micro-Intervention 2
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).
| Study group | Role | What they receive |
|---|---|---|
| Base BT (Skills Monitoring Off + No Micro-Interventions) | Active comparator | 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. Receives: Behavioral: Behavioral Therapy for Eating Disorders |
| Base BT + Skills Monitoring On + No Micro-Interventions | Experimental | 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. Receives: Behavioral: Behavioral Therapy for Eating Disorders; Behavioral: Skills Monitoring On |
| Base BT + Skills Monitoring On + Automated Reminder Messages | Experimental | 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. Receives: Behavioral: Behavioral Therapy for Eating Disorders; Behavioral: Skills Monitoring On; Behavioral: Automated Reminder Messages |
| Base BT + Skills Monitoring On + JITAIs | Experimental | 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). Receives: Behavioral: Behavioral Therapy for Eating Disorders; Behavioral: Skills Monitoring On; Behavioral: JITAIs |
| Base BT + Skills Monitoring Off + Automated Reminder Messages | Experimental | 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. Receives: Behavioral: Behavioral Therapy for Eating Disorders; Behavioral: Automated Reminder Messages |
| Base BT + Skills Monitoring Off + JITAIs | Experimental | 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). Receives: Behavioral: Behavioral Therapy for Eating Disorders; Behavioral: JITAIs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Binge eating frequency assessed by the Eating Disorder Examination
Frequency (number of days and number of instances) of binge eating over the past 28 days assessed by the Eating Disorder Examination
Measured: Changes from each assessment time point throughout treatment (3 assessments over 16 weeks) and at a 6 month follow-up assessment
Global Eating Pathology
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.
Measured: Changes from each assessment time point throughout treatment (3 assessments over 16 weeks) and at a 6 month follow-up assessment
Remission Status
Presence or absence of eating disorder diagnosis. Not in remission; in partial remission; or in full remission.
Measured: Changes from each assessment time point throughout treatment (3 assessments over 16 weeks) and at a 6 month follow-up assessment
BMI
kilogram/(meters^2), this will be calculated by assessors when participants provide their height and weight at all assessment points
Measured: Changes from each assessment time point throughout treatment (3 assessments over 16 weeks) and at a 6 month post-treatment follow-up assessment
Secondary outcomes (5)
Compensatory behavior frequency assessed by the Eating Disorder Examination (EDE)
Frequency (number of days and number of instances) of compensatory behaviors assessed by the Eating Disorder Examination
Measured: Changes from each assessment time point throughout treatment (3 assessments over 16 weeks) and at a 6 month follow-up assessment
Acceptability and Feasibility
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.
Measured: 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
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).
Measured: Changes from each weekly session over the course of the 16 week treatment
Emotional Self-regulation
Changes in emotional self-regulation will be assessed using the total score of the Difficulties in Emotional Regulation Scale (DERS)
Measured: Changes from each assessment time point throughout treatment (3 assessments over 16 weeks) and at a 6 month follow-up assessment
Self-regulation: Impulsivity
Changes in impulsivity will be assessed by the total score of the UPPS-P Impulsive Behaviors Scale.
Measured: Changes from each assessment time point throughout treatment (3 assessments over 16 weeks) and at a 6 month follow-up assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2022
- Study start6 Jan 2023
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bulimia NervosaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- MOST: multiphase optimization strategy
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 264 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nemours Children's Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Stephanie Manasse, Nemours Children's Clinic
- Investigators
- Stephanie Manasse, Ph.D., Principal investigator, Nemours Children's Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05473013
- Sponsor's protocol ID
- 2201009012
- Other IDs
- R01MH129478
- Status last verified
- Sep 2026
- First submitted
- 18 Jul 2022
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Juarascio AS, Presseller EK, Trainor C, Boda S, Manasse SM, Srivastava P, Forman EM, Zhang F. Optimizing digital health technologies to improve therapeutic skill use and acquisition alongside enhanced cognitive-behavior therapy for binge-spectrum eating disorders: Protocol for a randomized controlled trial. Int J Eat Disord. 2023 Feb;56(2):470-477. doi: 10.1002/eat.23864. Epub 2022 Nov 30.
PubMed 36448475
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Digital Health Technologies to Improve Therapeutic Skill Use and Acquisition
- ClinicalTrials.gov ID
- NCT05473013
- Acronym / sponsor ID
- 2201009012
- Conditions
- Bulimia Nervosa, Bulimia, Binge Eating, Binge-Eating Disorder
- Keywords
- Eating disorders, Bulimia Nervosa, Bulimia, Binge Eating, Binge Eating Disorder, Cognitive Behavioral Treatment for Eating Disorders, Digital health technologies (DHTs), Micro-Interventions
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 264 participants (estimated)
- Lead sponsor
- Nemours Children's ClinicUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 6 Jan 2023 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 25 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 6
- Model description
- MOST: multiphase optimization strategy
| Arm | Type | Receives |
|---|---|---|
| Base BT (Skills Monitoring Off + No Micro-Interventions) | Active comparator | Behavioral: Behavioral Therapy for Eating Disorders16 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. |
| Base BT + Skills Monitoring On + No Micro-Interventions | Experimental | Behavioral: Behavioral Therapy for Eating Disorders, Behavioral: Skills Monitoring On16 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. |
| Base BT + Skills Monitoring On + Automated Reminder Messages | Experimental | Behavioral: Behavioral Therapy for Eating Disorders, Behavioral: Skills Monitoring On, Behavioral: Automated Reminder Messages16 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. |
| Base BT + Skills Monitoring On + JITAIs | Experimental | Behavioral: Behavioral Therapy for Eating Disorders, Behavioral: Skills Monitoring On, Behavioral: JITAIs16 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). |
| Base BT + Skills Monitoring Off + Automated Reminder Messages | Experimental | Behavioral: Behavioral Therapy for Eating Disorders, Behavioral: Automated Reminder Messages16 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. |
| Base BT + Skills Monitoring Off + JITAIs | Experimental | Behavioral: Behavioral Therapy for Eating Disorders, Behavioral: JITAIs16 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). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioral Therapy for Eating DisordersStandard 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). | Behavioural | Base BT (Skills Monitoring Off + No Micro-Interventions), Base BT + Skills Monitoring Off + Automated Reminder Messages, Base BT + Skills Monitoring Off + JITAIs, Base BT + Skills Monitoring On + Automated Reminder Messages, Base BT + Skills Monitoring On + JITAIs, Base BT + Skills Monitoring On + No Micro-Interventions |
| Skills Monitoring OnAlso: Enhanced Skills MonitoringIntegrates 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. | Behavioural | Base BT + Skills Monitoring On + Automated Reminder Messages, Base BT + Skills Monitoring On + JITAIs, Base BT + Skills Monitoring On + No Micro-Interventions |
| Automated Reminder MessagesAlso: Micro-Intervention 1Integrates 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. | Behavioural | Base BT + Skills Monitoring Off + Automated Reminder Messages, Base BT + Skills Monitoring On + Automated Reminder Messages |
| JITAIsAlso: Micro-Intervention 2Integrates 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). | Behavioural | Base BT + Skills Monitoring Off + JITAIs, Base BT + Skills Monitoring On + JITAIs |
Primary outcome
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
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.
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.
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
5 secondary outcomes
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
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).
Frequency of skill use and success of skill use
Time frame: Changes from each weekly session over the course of the 16 week treatment
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Derived from this study: PubMed 36448475Juarascio AS, Presseller EK, Trainor C, Boda S, Manasse SM, Srivastava P, Forman EM, Zhang F. Optimizing digital health technologies to improve therapeutic skill use and acquisition alongside enhanced cognitive-behavior therapy for binge-spectrum eating disorders: Protocol for a randomized controlled trial. Int J Eat Disord. 2023 Feb;56(2):470-477. doi: 10.1002/eat.23864. Epub 2022 Nov 30.
- Individual participant dataSharing planned: Yes. 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.
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Eating Disorders, Binge Eating
Recruiting
Testing Intervention Strategies for Addressing Binge Eating and Food Insecurity
Binge Eating, Food Insecurity
Active, not recruitingObservational study
Neurobiological and Psychological Maintenance Mechanisms Associated With Anticipatory Reward in Bulimia Nervosa
Bulimia Nervosa
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Stephanie Manasse, Ph.D. principal investigator
Nemours Children's Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral Therapy for Eating Disorders, Skills Monitoring On and Automated Reminder Messages in people with Bulimia Nervosa and Bulimia, run by Nemours Children's Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Adarsh Javvaji, B.A. (302-433-1198, projectacquire@nemours.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05473013, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.