Digital Health Tech + Behavioral Therapy for Eating Disorders

Overseen By Sashi Govier, B.A.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Drexel University

Disqualifiers: Severe depression, Psychotic disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 18

Duration: 16 weeks

264 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests different methods to enhance therapy for individuals with bulimia nervosa and binge eating disorder. It combines traditional behavioral therapy with digital tools, such as phone apps, to remind participants to use skills learned in therapy. The goal is to determine which combination of self-monitoring and reminders most effectively helps manage eating habits. Individuals who have experienced at least 12 episodes of losing control over eating in the past 3 months and have a BMI of 18.5 or more may be suitable for this study. As an unphased trial, it offers participants the chance to explore innovative therapy enhancements that could significantly improve their eating habits.

Do I need to stop my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are already receiving treatment for an eating disorder, you are not eligible to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that digital health tools, such as automated reminder messages and just-in-time adaptive interventions (JITAIs), are generally safe for individuals with eating disorders. Studies examining these tools in similar contexts have found that users tolerate them well. For instance, ecological momentary interventions, a type of digital tool for eating disorders, have demonstrated promise without major safety issues.

Automated reminder messages and JITAIs provide timely prompts to help manage eating habits. These methods are integrated into smartphone apps, which many find easy to use. Reports suggest few negative effects, primarily because these tools are non-invasive and focus on supporting behavior.

However, as research on this combination of digital tools and therapy continues, it's important to consider personal comfort with using technology as part of treatment. Discuss any concerns about digital health tools with a healthcare provider to ensure they are suitable for individual needs. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it integrates digital health technology with traditional behavioral therapy to tackle eating disorders more effectively. Unlike standard treatment methods that primarily focus on self-monitoring eating patterns, this approach includes automated reminder messages and just-in-time adaptive interventions (JITAIs) through a smartphone app. These features aim to enhance skill usage and provide support during moments of need, potentially making therapy more adaptive and personalized. By leveraging technology to reinforce behavioral changes, this method could offer more immediate and tailored support to individuals, setting it apart from existing treatments.

What evidence suggests that this trial's treatments could be effective for eating disorders?

This trial will evaluate the effectiveness of digital health tools combined with behavioral therapy for eating disorders. Participants in different arms of the trial will receive various combinations of interventions. Some will receive automated reminder messages, which studies have shown can help people practice and learn new skills between therapy sessions, potentially improving outcomes for those with binge eating disorders. Other participants will receive just-in-time adaptive interventions (JITAIs). Research indicates that JITAIs can identify when someone might need extra support and send timely reminders to use their skills. Both automated reminders and JITAIs aim to enhance regular therapy by supporting skill use and learning, which could improve treatment outcomes for bulimia nervosa and binge eating disorder. ^{1 2 6 7 8}

Who Is on the Research Team?

Adrienne S Juarascio, Ph.D.

Principal Investigator

Drexel University

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Have a BMI at or above 18.5

Are located in the US and willing/able to participate in treatment and assessments

Are able to give consent

Exclusion Criteria

Are already receiving treatment for an eating disorder

I need urgent care for health issues caused by my eating disorder.

Have a BMI below 18.5

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 16 weekly sessions of standard behavioral therapy for eating disorders, with variations in self-monitoring and micro-interventions

16 weeks

16 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 6 and 12 months

12 months

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Automated Reminder Messages
• Behavioral Therapy for Eating Disorders
• JITAIs
• Skills Monitoring On

Trial Overview 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.

How Is the Trial Designed?

Group I: Base BT + Skills Monitoring On + No Micro-Interventions Experimental Treatment 2 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 + JITAIs Experimental Treatment 3 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 Messages Experimental Treatment 3 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 + JITAIs Experimental Treatment 2 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 Messages Experimental Treatment 2 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 Control 1 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.

Who Is Running the Clinical Trial?

Drexel University

Lead Sponsor

Trials

160

Recruited

48,600+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Published Research Related to This Trial

The study involved 170 participants with binge-eating disorder or bulimia nervosa, and those using a smartwatch alongside the Recovery Record app showed significantly higher study completion and engagement compared to those using only an iPhone.

Both groups experienced a significant reduction in binge-eating episodes over 30 days, with 60% of the smartwatch group and 66% of the iPhone group reporting fewer episodes, indicating the app's potential effectiveness in managing binge-eating behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Retention, engagement, and binge-eating outcomes: Evaluating feasibility of the Binge-Eating Genetics Initiative study. Flatt, RE., Thornton, LM., Smith, T., et al.[2022]

A randomized controlled trial with 355 participants showed that three low-threshold interventions (automated online self-help, expert-patient support, and their combination) significantly reduced eating disorder symptoms compared to a waiting list control.

While all active interventions were equally effective, those receiving expert-patient support reported higher satisfaction, indicating that guidance enhances user experience without affecting symptom reduction efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of an online self-help program, expert-patient support, and their combination for eating disorders: Results from a randomized controlled trial. Rohrbach, PJ., Dingemans, AE., Spinhoven, P., et al.[2023]

In a study of 84 patients undergoing treatment for eating disorders, those with anorexia used the self-monitoring app Recovery Record significantly more than those with bulimia, especially in the later weeks of treatment.

Overall app usage declined over the 26-week period, with factors like older age and no prior treatment linked to higher app engagement, suggesting that these characteristics may influence how patients interact with digital tools in their recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient use of a self-monitoring app during eating disorder treatment: Naturalistic longitudinal cohort study. Lindgreen, P., Lomborg, K., Clausen, L.[2023]

A survey of 722 participants revealed that the main advantages of e-health for eating disorders are its accessibility ('always there in times of need') and convenience ('travel not required'), with nearly 75% expressing intention to use such platforms for treatment or prevention.

Concerns about data privacy and content accuracy were significant barriers for about 50% of participants, highlighting the need for e-health platforms to address these issues while also providing features like clinician support and tailored feedback.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perspectives of e-health interventions for treating and preventing eating disorders: descriptive study of perceived advantages and barriers, help-seeking intentions, and preferred functionality. Linardon, J., Messer, M., Lee, S., et al.[2021]

Cognitive Behavioral Therapy (CBT) is the most researched treatment for bulimia nervosa and binge-eating disorder, but many patients struggle with effectively using the skills learned during treatment, which can negatively impact their outcomes.

Just-in-time adaptive interventions (JITAIs) using smartphone technology could enhance skill acquisition and utilization by providing real-time, tailored support during critical moments, potentially improving treatment effectiveness for patients with eating disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Just-in-time adaptive interventions: A novel approach for enhancing skill utilization and acquisition in cognitive behavioral therapy for eating disorders. Juarascio, AS., Parker, MN., Lagacey, MA., et al.[2020]

The study will evaluate the effectiveness of different combinations of mobile health (mHealth) components, specifically self-monitoring and microinterventions, in enhancing cognitive-behavioral therapy for individuals with binge-spectrum eating disorders, involving 264 participants over 16 sessions.

Results will help identify which mHealth components are most effective and how they can be personalized based on individual self-regulation levels, potentially leading to optimized digital interventions for binge eating disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Juarascio, AS., Presseller, EK., Trainor, C., et al.[2023]

A study involving 7 young women with a history of body image issues revealed that understanding their lived experiences is crucial for designing effective app-based interventions for eating disorders.

Key insights included the need for apps to address specific eating disorder symptoms, incorporate personal values and goals for recovery, and enhance social support to improve user engagement and retention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Informing mHealth and Web-Based Eating Disorder Interventions: Combining Lived Experience Perspectives With Design Thinking Approaches. Jarman, HK., McLean, SA., Rodgers, R., et al.[2022]

A text-messaging program for self-monitoring symptoms of bulimia nervosa was well-accepted by 87% of the 31 women participating in a 12-week cognitive-behavioral therapy (CBT) program, indicating high adherence to the intervention.

Participants showed significant reductions in binge eating and purging episodes, as well as improvements in depression and eating disorder symptoms, suggesting that mobile technology can effectively enhance treatment outcomes for bulimia nervosa.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile therapy: Use of text-messaging in the treatment of bulimia nervosa. Shapiro, JR., Bauer, S., Andrews, E., et al.[2018]

The Special Issue highlights the potential of technology to enhance the assessment and treatment of eating disorders, suggesting it can improve detection and understanding of these conditions.

Contributions emphasize the importance of optimizing technology-enhanced interventions to reach underserved populations and improve current assessment methods, indicating a significant shift in how eating disorders may be addressed in the future.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Introduction to the special issue on advancing assessment of, and interventions for, eating disorders via innovative uses of technology. Bauer, S., Goldschmidt, AB.[2020]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05473013

Study Details | NCT05473013 | Optimizing Digital Health ... 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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10152929/

Optimizing Digital Health Technologies to Improve ... The present study will provide critical insight into the efficacy of commonly used digital intervention components (ie, skills monitoring and micro- ...

3. reporter.nih.gov reporter.nih.gov/search/z-QlYM0iN0KIBkR4RhA11w/project-details/10429134

Project Details - NIH RePORTER PROJECT NARRATIVE Digital health technologies have high potential to promote between-session skill utilization and acquisition when used as a treatment ...

4. researchgate.net researchgate.net/publication/365856515_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_cont

Optimizing digital health technologies to improve ... Treatment outcomes will be measured using the Eating Disorder Examination and compared by treatment condition using multilevel models. Results ...

5. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2821341

Comparative Effectiveness of Three Digital Interventions for ... This randomized clinical trial found decreases in depression and anxiety symptoms across all DMHIs and minimal evidence that specific applications were better ...

6. jeatdisord.biomedcentral.com jeatdisord.biomedcentral.com/articles/10.1186/s40337-025-01329-4

Ecological momentary interventions for eating disorders This review examines existing research on EMIs for ED treatment, their design and content, and directions for future research.

7. sciencedirect.com sciencedirect.com/science/article/pii/S1740144525000762

Developing a digital mindfulness-based intervention to ... This paper describes the application of the person-based approach in developing a digital MBI to reduce risk factors for disordered eating in young people.

8. mental.jmir.org mental.jmir.org/2022/4/e32146

Detecting Mental Health Behaviors Using Mobile Interactions The aim of this study was to explore the potential of mobile sensing to detect indicators of binge-eating episodes.