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Identifying Effective Technological-based Augmentations to Enhance Outcomes From Self-help Cognitive Behavior Therapy for Binge Eating (CONQUER)

Primary Purpose

Binge Eating, Binge-Eating Disorder, Bulimia Nervosa

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Base self-help CBT program
Just-in-time, adaptive intervention (JITAIs) system
Advanced Digital Data Sharing (ADDS) with Coaches
Sponsored by
Drexel University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Binge Eating focused on measuring Cognitive behavior therapy, Self-help, Advanced Digital Data Sharing with Coaches, Just-in-time, adaptive interventions, Binge eating, Treatment

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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

Sites / Locations

  • Drexel UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Arm Label

Base self-help CBT program plus Advanced Digital Data Sharing (ADDS) with Coaches

Base self-help CBT program plus Just-in-time, adaptive interventions (JITAIs)

Base self-help CBT program plus JITAIs plus Advanced Digital Data Sharing with Coaches

Base self-help cognitive behavior therapy (CBT) program

Arm Description

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.

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 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.

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.

Outcomes

Primary Outcome Measures

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
Total number of treatment modules completed
The number of treatment modules completed will be captured from the smartphone application.
Rates of self-monitoring compliance
Number of data entries completed over the course of the treatment will be captured from the smartphone application.
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.

Secondary Outcome Measures

Severity of Global Eating Pathology
The Eating Disorder Examination is a semi-structured interview that measures eating. pathology. The EDE yields a total eating pathology score that will be used as an outcome variable. Global eating pathology is on a 0-6 point scale with higher scores indicating more significant eating pathology.
Compensatory behavior frequency
Frequency (number of days and number of instances) of compensatory behaviors assessed by the Eating Disorder Examination (EDE)
Acceptability
Perceived usefulness and ease-of-use of the technological components (the smartphone application) will be measured by the Technology Acceptance Model (TAM) Scales. A Feedback Questionnaire will also be used to measure qualitative acceptability of both the technological components of the study and the treatment components.
Acceptability and Feasibility
Assessment of feasibility will include % of eligible patients enrolled, treatment attrition (% of patients that prematurely terminate treatment), and study retention (% of patients that complete all assessment points). Data will also be collected on participants' use of self-help technological features, including time, duration, and frequency of use.

Full Information

First Posted
June 20, 2023
Last Updated
July 5, 2023
Sponsor
Drexel University
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1. Study Identification

Unique Protocol Identification Number
NCT05937243
Brief Title
Identifying Effective Technological-based Augmentations to Enhance Outcomes From Self-help Cognitive Behavior Therapy for Binge Eating
Acronym
CONQUER
Official Title
Using Factorial Design to Identify Effective Technological-based Augmentations to Enhance Outcomes From a Smartphone-based Self-help Cognitive Behavior Therapy for Binge Eating
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
August 31, 2025 (Anticipated)
Study Completion Date
August 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Drexel University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Self-help cognitive behavior therapies (CBTs) for binge eating are maximally effective when paired with periodic contact with expert clinicians. Clinicians likely improve outcomes because they are trained to utilize specific behavior change techniques for facilitating treatment adherence and skills utilization during self-help CBT programs. Given the limited availability of expert clinicians, it is critical to understand how to enhance outcomes from self-help CBTs without clinician involvement. Technological innovations such as Advanced Digital Data Sharing with Coaches and Just-in-time adaptive interventions (JITAIs) can potentially emulate some of the behavior change techniques used by expert clinicians and improve treatment targets. The current study will use a 2 x 2 full factorial design in which 76 individuals with bulimia nervosa (BN) or binge eating disorders (BED) are assigned to one of four treatment conditions, i.e., representing each permutation of Advanced DDS with Coaches (Advanced DDS with Coaches ON vs. Advanced DDS with Coaches OFF) and JITAIs (JITAIs ON vs. JITAIs OFF) as an augmentation to self-help CBT program. Self-help CBT will deliver an evidence-based program based on Dr. Chris Fairburn's Overcoming Binge Eating self-help book via a smartphone app without clinician involvement. This app will constitute 12 treatment modules and an electronic self-monitoring form to record eating and eating disorder behaviors for use over 12 weeks without clinician involvement. The primary aims of the study will be to (1) Test target engagement, i.e., that each factor including Advanced DDS with Coach and JITAIs produces greater improvements in treatment adherence and skills utilization, (2) Test the feasibility and acceptability of two intervention factors as adjuncts to self-guided CBT program for binge eating; (3) Test the initial efficacy, i.e., that each factor including Advanced DDS with Coach and JITAIs will produce greater improvements in binge eating frequency at post-treatment, and 3 months follow-up; and (4) Test target validation, i.e., that improvements in treatment adherence and skills utilization will be associated with reductions in binge eating. The exploratory aim will be to quantify the intervention factors' interaction effects, which may be partially additive (because intervention factors overlap and/or there is diminishing return), fully additive, or synergistic (in that intervention factors may partially depend on each other).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Binge Eating, Binge-Eating Disorder, Bulimia Nervosa, Bulimia
Keywords
Cognitive behavior therapy, Self-help, Advanced Digital Data Sharing with Coaches, Just-in-time, adaptive interventions, Binge eating, Treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
2*2 factorial design
Masking
Participant
Allocation
Randomized
Enrollment
76 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Base self-help CBT program plus Advanced Digital Data Sharing (ADDS) with Coaches
Arm Type
Experimental
Arm Description
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.
Arm Title
Base self-help CBT program plus Just-in-time, adaptive interventions (JITAIs)
Arm Type
Experimental
Arm Description
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.
Arm Title
Base self-help CBT program plus JITAIs plus Advanced Digital Data Sharing with Coaches
Arm Type
Experimental
Arm Description
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.
Arm Title
Base self-help cognitive behavior therapy (CBT) program
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Base self-help CBT program
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Just-in-time, adaptive intervention (JITAIs) system
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Advanced Digital Data Sharing (ADDS) with Coaches
Intervention Description
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.
Primary Outcome Measure Information:
Title
Binge eating frequency
Description
Frequency (number of days and number of instances) of binge eating over the past 28 days assessed by the Eating Disorder Examination
Time Frame
Changes from each assessment time point throughout treatment (3 assessments over 12 weeks) and at a 3 month post-treatment follow-up assessment
Title
Total number of treatment modules completed
Description
The number of treatment modules completed will be captured from the smartphone application.
Time Frame
Changes from each assessment time point throughout treatment (3 assessments over 12 weeks) and at a 3 month post-treatment follow-up assessment
Title
Rates of self-monitoring compliance
Description
Number of data entries completed over the course of the treatment will be captured from the smartphone application.
Time Frame
Changes from each assessment time point throughout treatment (3 assessments over 12 weeks) and at a 3 month post-treatment follow-up assessment
Title
Frequency of skills utilization
Description
Number of times a therapeutic skills was used as indicated by participant on the self-monitored eating records and end-of-the-week surveys.
Time Frame
Changes from each assessment time point throughout treatment (3 assessments over 12 weeks) and at a 3 month post-treatment follow-up assessment
Secondary Outcome Measure Information:
Title
Severity of Global Eating Pathology
Description
The Eating Disorder Examination is a semi-structured interview that measures eating. pathology. The EDE yields a total eating pathology score that will be used as an outcome variable. Global eating pathology is on a 0-6 point scale with higher scores indicating more significant eating pathology.
Time Frame
Changes from each assessment time point throughout treatment (3 assessments over 12 weeks) and at a 3 month post-treatment follow-up assessment
Title
Compensatory behavior frequency
Description
Frequency (number of days and number of instances) of compensatory behaviors assessed by the Eating Disorder Examination (EDE)
Time Frame
Changes from each assessment time point throughout treatment (3 assessments over 12 weeks) and at a 3 month post-treatment follow-up assessment
Title
Acceptability
Description
Perceived usefulness and ease-of-use of the technological components (the smartphone application) will be measured by the Technology Acceptance Model (TAM) Scales. A Feedback Questionnaire will also be used to measure qualitative acceptability of both the technological components of the study and the treatment components.
Time Frame
Changes from each assessment time point throughout treatment after baseline so 2 assessments over 12 weeks (the mid-treatment and post-treatment assessments)
Title
Acceptability and Feasibility
Description
Assessment of feasibility will include % of eligible patients enrolled, treatment attrition (% of patients that prematurely terminate treatment), and study retention (% of patients that complete all assessment points). Data will also be collected on participants' use of self-help technological features, including time, duration, and frequency of use.
Time Frame
Changes from each assessment time point throughout treatment after baseline so 2 assessments over 12 weeks (the mid-treatment and post-treatment assessments)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Paakhi Srivastava
Phone
2678156511
Email
ps887@drexel.edu
Facility Information:
Facility Name
Drexel University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sydney Kong
Phone
215-553-7100
Email
EDresearch@drexel.edu
First Name & Middle Initial & Last Name & Degree
Paakhi Srivastava, Ph.D

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
Within one year of project completion
IPD Sharing Access Criteria
Supporting documentation to allow other researchers to use this data easily and appropriately will be included.

Learn more about this trial

Identifying Effective Technological-based Augmentations to Enhance Outcomes From Self-help Cognitive Behavior Therapy for Binge Eating

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