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Behavioural Intervention

Tech-based Interventions for Binge Eating (CONQUER Trial)

N/A

Waitlist Available

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 12 weeks) and at a 3 month post-treatment follow-up assessment

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new way of providing evidence-based treatment for binge eating without clinician support using two types of tech-based interventions and a smartphone app.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves behavioral therapy through technology without medications, side effects are minimal but may include discomfort from confronting personal eating habits or stress from regular engagement with the intervention tools.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ changes from each assessment time point throughout treatment (3 assessments over 12 weeks) and at a 3 month post-treatment follow-up assessment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~changes from each assessment time point throughout treatment (3 assessments over 12 weeks) and at a 3 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 12 weeks) and at a 3 month post-treatment follow-up assessment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Binge eating frequency

Frequency of skills utilization

Rates of self-monitoring compliance

+1 more

Secondary study objectives

Acceptability

Acceptability and Feasibility

Compensatory behavior frequency

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Base self-help CBT program plus Just-in-time, adaptive interventions (JITAIs)Experimental Treatment2 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 CoachesExperimental Treatment3 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 CoachesExperimental Treatment2 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) programActive Control1 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.

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