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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

Study 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.Check my eligibility
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.See study design
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

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

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
150 Previous Clinical Trials
47,501 Total Patients Enrolled
13 Trials studying Bulimia
950 Patients Enrolled for Bulimia
National Institute of Mental Health (NIMH)NIH
2,785 Previous Clinical Trials
2,689,091 Total Patients Enrolled
34 Trials studying Bulimia
21,909 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this trial actively seeking participants at the moment?

"According to the data posted on clinicaltrials.gov, this medical trial has already ceased enrollment of new patients. It was initially published on December 1st 2022 and last modified on July 21st 2022; however, there are currently 106 other studies that remain open for recruitment."

Answered by AI

Can persons aged 65 and above participate in the experiment?

"This study is taking applications from adults aged 18 to 70."

Answered by AI

Am I eligible to partake in this experiment?

"This research is actively searching for 264 individuals aged 18-70 suffering from bulimia nervosa. Qualifying patients must have experienced at least 12 uncontrolled episodes in the past 3 months, have a BMI of 18.5 or higher, be legally able to partake in assessments and treatment within the United Sates and sign informed consent forms."

Answered by AI

What is the expected outcome of this investigation?

"This medical trial sets out to measure participants' BMI over a time frame of 16 weeks, followed by 6 and 12-month post-treatment assessments. Secondary outcomes include changes in impulsivity (as measured via the UPPS-P Impulsive Behaviors Scale), acceptability/feasibility (measured through TAM scales and a feedback questionnaire) as well as frequency/success rate of skill use related to emotional regulation."

Answered by AI
~148 spots leftby Dec 2025