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Digital Health Tech + Behavioral Therapy for Eating Disorders

N/A
Recruiting
Led By Adrienne S Juarascio, Ph.D.
Research Sponsored by Drexel University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up changes from each assessment time point throughout treatment (3 assessments over 16 weeks) and at a 6 month and a 12-month post-treatment follow-up assessment
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing how well two types of self-monitoring (tracking what you eat and how you feel) and two types of micro-interventions (daily reminders and weekly check-ins) work when combined with standard cognitive behavioral therapy for bulimia nervosa and binge eating disorder.

Who is the study for?
This trial is for US residents with a BMI of 18.5 or higher who have had at least 12 episodes of losing control over eating in the past 3 months and can consent to treatment. It's not for those underweight, pregnant, already in eating disorder treatment, needing urgent medical care due to their disorder, or with severe mental health issues.
What is being tested?
The study tests how well different self-monitoring techniques and micro-interventions work alongside cognitive behavioral therapy for bulimia nervosa and binge eating disorder. It looks at the complexity of these digital tools and their impact on skill learning and use over time.
What are the potential side effects?
Since this trial involves behavioral therapy and digital interventions rather than medication, typical drug side effects are not expected. However, participants may experience discomfort or emotional distress when confronting their eating behaviors.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~changes from each assessment time point throughout treatment (3 assessments over 16 weeks) and at a 6 month and a 12-month post-treatment follow-up assessment
This trial's timeline: 3 weeks for screening, Varies for treatment, and changes from each assessment time point throughout treatment (3 assessments over 16 weeks) and at a 6 month and a 12-month post-treatment follow-up assessment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
BMI
Binge eating frequency assessed by the Eating Disorder Examination
Global Eating Pathology
+1 more
Secondary study objectives
Acceptability and Feasibility
Compensatory behavior frequency assessed by the Eating Disorder Examination (EDE)
Emotional Self-regulation
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

6Treatment groups
Experimental Treatment
Active Control
Group I: Base BT + Skills Monitoring On + No Micro-InterventionsExperimental Treatment2 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.
Group II: Base BT + Skills Monitoring On + JITAIsExperimental Treatment3 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. 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).
Group III: Base BT + Skills Monitoring On + Automated Reminder MessagesExperimental Treatment3 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. 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.
Group IV: Base BT + Skills Monitoring Off + JITAIsExperimental Treatment2 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. 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).
Group V: Base BT + Skills Monitoring Off + Automated Reminder MessagesExperimental Treatment2 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. 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.
Group VI: Base BT (Skills Monitoring Off + No Micro-Interventions)Active Control1 Intervention
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.

Find a Location

Who is running the clinical trial?

Drexel UniversityLead Sponsor
155 Previous Clinical Trials
47,958 Total Patients Enrolled
14 Trials studying Bulimia
1,000 Patients Enrolled for Bulimia
National Institute of Mental Health (NIMH)NIH
2,933 Previous Clinical Trials
2,745,774 Total Patients Enrolled
37 Trials studying Bulimia
41,999 Patients Enrolled for Bulimia
Adrienne S Juarascio, Ph.D.Principal InvestigatorDrexel University

Media Library

Automated Reminder Messages Clinical Trial Eligibility Overview. Trial Name: NCT05473013 — N/A
Bulimia Research Study Groups: Base BT + Skills Monitoring On + Automated Reminder Messages, Base BT (Skills Monitoring Off + No Micro-Interventions), Base BT + Skills Monitoring On + No Micro-Interventions, Base BT + Skills Monitoring On + JITAIs, Base BT + Skills Monitoring Off + Automated Reminder Messages, Base BT + Skills Monitoring Off + JITAIs
Bulimia Clinical Trial 2023: Automated Reminder Messages Highlights & Side Effects. Trial Name: NCT05473013 — N/A
Automated Reminder Messages 2023 Treatment Timeline for Medical Study. Trial Name: NCT05473013 — N/A
~85 spots leftby Dec 2025
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