An interventional study of Behavioral Therapy for Eating Disorders and Skills Monitoring On in Bulimia Nervosa, Bulimia and Binge Eating, sponsored by Nemours Children's Clinic. Recruiting at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-11.
Sponsored by Nemours Children's Clinic · Not applicable, Interventional, and Treatment
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).
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).
173 studies on the registry are indexed under Bulimia Nervosa; 39 are open to participants now.
This study's planned enrollment of 264 is above the median of 60 across 121 interventional studies indexed under Bulimia Nervosa.
Browse Bulimia Nervosa studies →Nemours Children's Clinic is the lead sponsor of 130 studies on the registry; 26 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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 · Behavioral: Skills Monitoring On
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 · Behavioral: Skills Monitoring On · Behavioral: 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 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 · Behavioral: Skills Monitoring On · Behavioral: 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 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 · Behavioral: 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 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 · Behavioral: JITAIs
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.
Also known as: Enhanced Skills Monitoring
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.
Also known as: Micro-Intervention 1
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).
Also known as: Micro-Intervention 2
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
Time frame: 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.
Time frame: 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.
Time frame: 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
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
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
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
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.
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
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).
Time frame: 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)
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
Changes in impulsivity will be assessed by the total score of the UPPS-P Impulsive Behaviors Scale.
Time frame: Changes from each assessment time point throughout treatment (3 assessments over 16 weeks) and at a 6 month follow-up assessment
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: Within one year of project completion
Access criteria: We will include supporting documentation to allow other researchers to use this data easily and appropriately.
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