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

Trial Summary

What is the purpose of this trial?

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).

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.

What data supports the effectiveness of this treatment for eating disorders?

Research shows that app-based interventions and text-messaging programs can help reduce symptoms of eating disorders by supporting self-monitoring and enhancing cognitive-behavioral therapy (CBT). These digital tools can improve access to treatment and help patients track their progress, making them a valuable addition to traditional therapy methods. ^{1 2 3 4 5}

Is the digital health tech and behavioral therapy for eating disorders safe for humans?

Research on digital health technologies like self-monitoring apps and text-messaging programs used alongside cognitive-behavioral therapy (CBT) for eating disorders suggests they are generally safe for humans, as these studies focus on improving treatment without reporting significant safety concerns. ^{1 2 6 7 8}

How is the Digital Health Tech + Behavioral Therapy treatment for eating disorders different from other treatments?

This treatment is unique because it combines digital health technology, like smartphone apps, with behavioral therapy to provide real-time, personalized support through automated reminders and just-in-time adaptive interventions (JITAIs). These tools help patients practice and acquire therapeutic skills more effectively by delivering interventions at moments of need, which is not typically available in standard treatments. ^{1 2 3 6 9}

Research Team

Adrienne S Juarascio, Ph.D.

Principal Investigator

Drexel University

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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 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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Mobile therapy: Use of text-messaging in the treatment of bulimia nervosa. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Patient use of a self-monitoring app during eating disorder treatment: Naturalistic longitudinal cohort study. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

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

4. Canada pubmed.ncbi.nlm.nih.gov

Informing mHealth and Web-Based Eating Disorder Interventions: Combining Lived Experience Perspectives With Design Thinking Approaches. [2022]

5. Germany 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. [2021]

6. United States 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. [2023]

7. United States 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. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Retention, engagement, and binge-eating outcomes: Evaluating feasibility of the Binge-Eating Genetics Initiative study. [2022]

9. United States 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. [2020]