Identifying Effective Technological-based Augmentations to Enhance Outcomes From Self-help Cognitive Behavior Therapy for Binge Eating
CONQUER
Using Factorial Design to Identify Effective Technological-based Augmentations to Enhance Outcomes From a Smartphone-based Self-help Cognitive Behavior Therapy for Binge Eating
1 other identifier
interventional
76
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2022
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2022
CompletedFirst Submitted
Initial submission to the registry
June 20, 2023
CompletedFirst Posted
Study publicly available on registry
July 10, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2025
CompletedAugust 23, 2024
August 1, 2024
3 years
June 20, 2023
August 21, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Binge eating frequency
Frequency (number of days and number of instances) of binge eating over the past 28 days assessed by the Eating Disorder Examination
Changes from each assessment time point throughout treatment (3 assessments over 12 weeks) and at a 3 month post-treatment follow-up assessment
Total number of treatment modules completed
The number of treatment modules completed will be captured from the smartphone application.
Changes from each assessment time point throughout treatment (3 assessments over 12 weeks) and at a 3 month post-treatment follow-up assessment
Rates of self-monitoring compliance
Number of data entries completed over the course of the treatment will be captured from the smartphone application.
Changes from each assessment time point throughout treatment (3 assessments over 12 weeks) and at a 3 month post-treatment follow-up assessment
Frequency of skills utilization
Number of times a therapeutic skills was used as indicated by participant on the self-monitored eating records and end-of-the-week surveys.
Changes from each assessment time point throughout treatment (3 assessments over 12 weeks) and at a 3 month post-treatment follow-up assessment
Secondary Outcomes (4)
Severity of Global Eating Pathology
Changes from each assessment time point throughout treatment (3 assessments over 12 weeks) and at a 3 month post-treatment follow-up assessment
Compensatory behavior frequency
Changes from each assessment time point throughout treatment (3 assessments over 12 weeks) and at a 3 month post-treatment follow-up assessment
Acceptability
Changes from each assessment time point throughout treatment after baseline so 2 assessments over 12 weeks (the mid-treatment and post-treatment assessments)
Acceptability and Feasibility
Changes from each assessment time point throughout treatment after baseline so 2 assessments over 12 weeks (the mid-treatment and post-treatment assessments)
Study Arms (4)
Base self-help CBT program plus Advanced Digital Data Sharing (ADDS) with Coaches
EXPERIMENTALWhen 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.
Base self-help CBT program plus Just-in-time, adaptive interventions (JITAIs)
EXPERIMENTALWhen 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.
Base self-help CBT program plus JITAIs plus Advanced Digital Data Sharing with Coaches
EXPERIMENTALWhen 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.
Base self-help cognitive behavior therapy (CBT) program
ACTIVE COMPARATORThe 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.
Interventions
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 over 12 weeks. 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 participant 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. In addition, participants will track their eating and eating disorder behaviors using the self-help app.
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.
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.
Eligibility Criteria
You may qualify if:
- Have experienced 12 or more loss of control episodes within the previous 3 months
- 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
You may not qualify if:
- Are unable to fluently speak, write and read English
- Have a BMI below 18.5
- Are already receiving treatment for an eating disorder
- Require immediate treatment for medical complications as a result of eating disorder symptoms
- Have a mental handicap, or are experiencing other severe psychopathology that would limit the participants' ability to comply with the demands of the current study (e.g. severe depression with suicidal intent, active psychotic disorder, severe substance use)
- Are pregnant or are planning to become pregnant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Drexel University
Philadelphia, Pennsylvania, 19104, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 20, 2023
First Posted
July 10, 2023
Study Start
September 1, 2022
Primary Completion
August 31, 2025
Study Completion
August 31, 2025
Last Updated
August 23, 2024
Record last verified: 2024-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- Within one year of project completion
- Access Criteria
- Supporting documentation to allow other researchers to use this data easily and appropriately will be included.
All guidelines for data sharing through the National Database for Clinical Trials Related to Mental Illness (NDCT) and the NIMH Data Archive (NDA) will be duly followed. All de-identified data will be submitted to the NDA at the item level and subject level.