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

76 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to test the feasibility, acceptability and efficacy of two technology-based intervention systems (including an Advanced Digital Data Sharing (ADDS) with Coaches or a smartphone-based just-in-time, adaptive interventions (JITAIs) system) for improving treatment adherence, skills utilization and binge eating when used in conjunction with a self-help cognitive behavior therapy \[CBT\] delivered via a smartphone application \[app\]). The study is being conducted to test a novel approach to providing evidence-based treatment for binge eating without clinician support in a routine clinical setting.

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 data supports the effectiveness of the treatment Advanced Digital Data Sharing (ADDS) with Coaches, Base self-help CBT program, Just-in-time, adaptive intervention (JITAIs) system for binge eating?

Research shows that cognitive-behavioral therapy (CBT) self-help programs, especially when delivered through digital platforms like smartphone apps or the internet, can effectively reduce binge eating behaviors and improve related symptoms. These digital interventions, often guided by coaches, have been well-received by patients and maintain their effectiveness over time. ^{1 2 3 4 5}

Is tech-based intervention for binge eating safe for humans?

The studies suggest that tech-based interventions, like internet-guided self-help and smartphone-assisted programs, are generally well accepted and show positive results for eating disorders without specific safety concerns mentioned. ^{1 2 4 6 7}

How does the Base self-help CBT program differ from other treatments for binge eating?

The Base self-help CBT program is unique because it uses technology, like smartphone apps and the Internet, to make cognitive-behavioral therapy (CBT) more accessible and convenient for people with binge eating disorder. This tech-based approach allows for guided self-help, which can be more flexible and easier to access than traditional in-person therapy sessions. ^{1 4 8 9 10}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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 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]

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]

References

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

Randomized controlled trial comparing smartphone assisted versus traditional guided self-help for adults with binge eating. [2023]

2. United States 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. [2022]

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

Effects of an Acceptance-Facilitating Intervention on Acceptance and Usage of Digital Interventions for Binge Eating. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Randomised controlled trial of a guided self-help treatment on the Internet for binge eating disorder. [2022]

5. England pubmed.ncbi.nlm.nih.gov

INTERBED: internet-based guided self-help for overweight and obese patients with full or subsyndromal binge eating disorder. A multicenter randomized controlled trial. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Prognostic significance of two sub-categorization methods for the treatment of binge eating disorder: negative affect and overvaluation predict, but do not moderate, specific outcomes. [2021]

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

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

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

Characterizing behavior change techniques used in the self-management of binge eating and weight: Applying a user-centered design approach. [2023]

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

Effectiveness of web-based guided self-help cognitive behavioral therapy-enhanced for binge-eating disorder: An implementation study. [2023]

10. 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]