Tech-based Interventions for Binge Eating

(CONQUER Trial)

Overseen By Paakhi Srivastava

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Drexel University

Disqualifiers: Eating disorder treatment, Severe psychopathology, Pregnancy, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how tech-based tools can help people manage binge eating more effectively. Participants will use a self-help app based on cognitive behavior therapy (CBT), a method that helps change negative thought patterns. Some participants will also receive real-time interventions or support from coaches through digital tools, such as the Advanced Digital Data Sharing (ADDS) system and the Just-in-time, adaptive intervention (JITAIs) system, to determine which combination works best. This trial is suitable for those who have experienced 12 or more episodes of loss of control over eating in the past three months and have a BMI of at least 18.5. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could shape future treatments for binge eating.

Will I have to stop taking my current medications?

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 prior data suggests that these technology-based interventions are safe for binge eating treatment?

Research has shown that digital self-monitoring tools, such as the Advanced Digital Data Sharing (ADDS) with coaches, have been used in weight loss programs. These tools track activities like eating and exercise. One study found that digital tools with coach support improved eating habits and reduced binge eating. This suggests that people generally find this approach easy to use.

For Just-in-time adaptive interventions (JITAIs), studies have shown they can provide timely help by adjusting to a person's needs in real-time. This method manages triggers for disordered eating. Research indicates that this approach effectively supports behavior change without major side effects.

Both methods aim to improve eating habits and reduce binge eating. By using digital tools and coaching instead of medications, they typically have fewer side effects. Studies suggest these methods are safe and well-received by participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these tech-based interventions for binge eating because they offer a unique combination of digital tools that can enhance treatment adherence and skills utilization. Unlike traditional self-help cognitive behavior therapy (CBT), these interventions use Just-in-time, adaptive interventions (JITAIs) to deliver personalized, real-time support based on machine learning algorithms. Additionally, the Advanced Digital Data Sharing (ADDS) with Coaches provides an innovative way for trained coaches to monitor participants' progress and offer targeted guidance through weekly emails. These features could make the treatment more effective by providing timely and tailored support, which is not typically available in standard binge eating treatments.

What evidence suggests that this trial's technology-based interventions could be effective for binge eating?

Research shows that technology-based methods can help treat binge eating. In this trial, participants may receive different interventions. One option is the Just-in-time adaptive interventions (JITAIs) system, which uses real-time information to offer support exactly when needed. Studies indicate that JITAIs can help participants adhere to their treatment plans and use skills more effectively, making it easier to manage binge eating. Another option is the Advanced Digital Data Sharing (ADDS) with Coaches, which allows coaches to track participants' progress and provide feedback, leading to better results. Research has found that sharing self-monitoring data with a coach can increase engagement and satisfaction. Both methods aim to enhance the success of the base self-help cognitive behavior therapy (CBT) delivered through a smartphone app. ^{1 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for individuals in the US with a BMI of 18.5 or higher who have had at least 12 episodes of loss of control eating in the past 3 months. They must be able to consent and participate fully, not currently receiving eating disorder treatment, and not have severe mental health issues that could interfere with participation.

Inclusion Criteria

Have experienced 12 or more loss of control episodes within the previous 3 months

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

Are able to give consent

Exclusion Criteria

I am currently receiving treatment for an eating disorder.

Have a BMI below 18.5

Are pregnant or are planning to become pregnant

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in a self-help CBT program delivered via a smartphone app, with optional technological augmentations such as JITAIs and Advanced DDS with Coaches, over 12 weeks

12 weeks

Weekly self-assessments via app

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of binge eating frequency and other outcomes

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Advanced Digital Data Sharing (ADDS) with Coaches
• Base self-help CBT program
• Just-in-time, adaptive intervention (JITAIs) system

Trial Overview The study tests two tech-based systems: ADDS (Advanced Digital Data Sharing) with Coaches and a JITAIs (Just-in-time adaptive interventions) system, both used alongside self-help CBT via an app to see if they help people stick to treatment better and reduce binge eating.

How Is the Trial Designed?

Group I: Base self-help CBT program plus Just-in-time, adaptive interventions (JITAIs) Experimental Treatment 2 Interventions

When JITAIs are turned ON, the base self-help app will be used to deliver targeted, personalized and automated interventions during algorithm-identified moments when participants could benefit from receiving an intervention for improving two key areas including 1) treatment adherence, and 2) skills utilization based on responses (or lack thereof) in self-help app. When JITAIs are turned OFF, participants will not receive interventions in real-time on the base self-help app.

Group II: Base self-help CBT program plus JITAIs plus Advanced Digital Data Sharing with Coaches Experimental Treatment 3 Interventions

When Advanced DDS with Coaches and JITAIs are both ON, participants will receive machine learning-informed interventions. In addition, participants will also receive weekly emails from coaches to provide additional support to improve treatment adherence and skills utilization.

Group III: Base self-help CBT program plus Advanced Digital Data Sharing (ADDS) with Coaches Experimental Treatment 2 Interventions

When Advanced DDS with Coaches is turned ON, coaches having a bachelor's degree in health-related fields will have access to a secure web portal called the clinical portal. The portal will also mimic four key behavior change techniques typically employed by an expert clinician including 1) gather data on target behaviors from the base self-help app (i.e., uptake of weekly module, self-monitoring compliance, and skills use), 2) synthesize participants' behavioral data on treatment targets, 3) flag data to indicate behaviors needing improvement and 4) use sophisticated algorithms to generate recommendations for intervening on identified data patterns. Using this information, the coaches will send one weekly email to facilitate improvement in treatment targets over 12 weeks. When Advanced DDS with Coaches is turned OFF, participants' will not have their data shared and will not receive emails from the coaches.

Group IV: Base self-help cognitive behavior therapy (CBT) program Active Control 1 Intervention

The self-help app will deliver 12 modules that will be based on Chris Fairburn's "Overcoming Binge Eating" self-help book, the most widely used self-help resource for binge eating. Treatment modules will aim to 1) provide psychoeducation on maintenance factors for binge eating, 2) teach CBT skills designed to interrupt these maintenance factors, and 3) coach participants to set personalized goals each week. Modules will be completed in succession over the course of 12 weeks and a new module will be made open each week. At the end of each weekly module, participants will complete an end-of-the-week survey and report on the frequency of skills use in the past week. In addition, participants will track their eating and eating disorder behaviors using the self-help app.

Who Is Running the Clinical Trial?

Drexel University

Lead Sponsor

Trials

160

Recruited

48,600+

Published Research Related to This Trial

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]

Cognitive-behavioral therapy led by a therapist (CBTth) is significantly more effective than guided self-help (CBTgsh) for treating binge-eating disorder, with a 20-fold higher likelihood of treatment completion and nearly 15-fold higher likelihood of remission based on a study of 457 participants.

Weight concern plays a crucial role in treatment outcomes, with lower weight concern associated with better remission rates in both CBT methods, but longer treatment duration positively impacts remission in CBTth while negatively affecting CBTgsh.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical moderators and predictors of cognitive-behavioral therapy by guided-self-help versus therapist-led for binge-eating disorder: Analysis of aggregated clinical trials. Grilo, CM., Thompson-Brenner, H., Shingleton, RM., 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 study involving 66 participants with binge-eating disorder or bulimia nervosa found that the Noom Monitor app combined with guided self-help treatments (CBT-GSH) significantly reduced objective bulimic episodes compared to traditional CBT-GSH alone.

Participants using the Noom app showed better adherence to meal and snack guidelines, which helped mediate the treatment's effectiveness, although both treatments had similar remission rates at the 6-month follow-up.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized controlled trial comparing smartphone assisted versus traditional guided self-help for adults with binge eating. Hildebrandt, T., Michaelides, A., Mackinnon, D., et al.[2023]

A randomized controlled study involving 74 women demonstrated that an Internet-guided self-help program based on cognitive behavioral therapy (CBT) significantly improved binge eating behaviors and related psychological factors over six months, with benefits maintained at a six-month follow-up.

The program was well-accepted by participants, indicating that transferring CBT techniques to an online format can effectively address binge eating disorder (BED) symptoms and improve overall eating disorder psychopathology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomised controlled trial of a guided self-help treatment on the Internet for binge eating disorder. Carrard, I., Crépin, C., Rouget, P., et al.[2022]

An acceptance-facilitating intervention (AFI) significantly improved acceptance ratings of digital interventions for binge eating among 398 participants, highlighting its effectiveness in addressing misconceptions and promoting positive attitudes.

Despite the increased acceptance, there were no differences in the actual usage or adherence rates to the digital interventions between the AFI and control groups, suggesting that while acceptance can be enhanced, it does not necessarily translate to increased engagement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of an Acceptance-Facilitating Intervention on Acceptance and Usage of Digital Interventions for Binge Eating. Linardon, J., Anderson, C., Chapneviss, T., et al.[2022]

In a study of 278 patients with binge-eating disorder (BED), web-based guided self-help cognitive behavioral therapy-enhanced (CBT-E) led to a significant reduction in binge-eating episodes, from an average of 16 episodes per 4 weeks to just 5 episodes during the last 4 weeks of treatment.

30% of participants achieved abstinence from binge eating, and 28% reported full recovery, indicating that guided self-help CBT-E is effective in real-world clinical settings, with large effect sizes for all outcome measures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of web-based guided self-help cognitive behavioral therapy-enhanced for binge-eating disorder: An implementation study. Melisse, B., van den Berg, E., de Beurs, E.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10231946/

Sharing digital self-monitoring data with others to enhance ... Participants in behavioral weight loss (BWL) programs increasingly use digital tools to self-monitor weight, physical activity, and dietary intake.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12336791/

Open Pilot Trial of a Coached Digital Program for Lower‐ ... This pilot trial demonstrated that lower‐income adults with eating disorders had relatively high rates of engagement and satisfaction with a brief online guided ...

3. bmchealthservres.biomedcentral.com bmchealthservres.biomedcentral.com/articles/10.1186/s12913-024-11876-2

Exploring successes, barriers, and enablers in the one-year ... The coaches noted significant positive changes among patients, including increased self-compassion, reduced weight-related stress, and a shift ...

4. taggs.hhs.gov taggs.hhs.gov/Detail/AwardDetail?arg_AwardNum=R34MH130480&arg_ProgOfficeCode=134

Award Information | HHS TAGGS Thus, Advanced Digital Data Sharing system may allow coaches to function in a more skilled way without receiving extensive training in behavior change ...

5. ctv.veeva.com ctv.veeva.com/study/identifying-effective-technological-based-augmentations-to-enhance-outcomes-from-self-help-cognitive

Identifying Effective Technological-based Augmentations to ... When Advanced DDS with Coaches is turned OFF, participants' will not have their data shared and will not receive emails from the coaches.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11537830/

Coach access to digital self-monitoring data This study experimentally tested whether coach access to participants' digital self-monitoring data improved behavioral weight loss (BWL) ...

7. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/43/NCT05937243/ICF_002.pdf

based augmentations for improving treatment adherence ... In the Self-help CBT program plus Advanced DDS with coaches condition, the data tracked on the smartphone app will be shared with coaches (i.e.,.

8. psychiatryonline.org psychiatryonline.org/doi/full/10.1176/appi.ps.202100616

Effects of an Acceptance-Facilitating Intervention on ... AFIs can positively influence participants' acceptance of digital interventions for binge eating and can address common barriers associated with their use.