Binge EatingCONQUERNCT05937243
Identifying Effective Technological-based Augmentations to Enhance Outcomes From Self-help Cognitive Behavior Therapy for Binge Eating
A study testing Base self-help CBT program, Just-in-time, adaptive intervention (JITAIs) system and Advanced Digital Data Sharing (ADDS) with Coaches in people with Binge Eating and Binge-Eating Disorder, run by Drexel University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Binge Eating, Binge-Eating Disorder, Bulimia Nervosa
- What is being tested?
- Base self-help CBT program, Just-in-time, adaptive intervention (JITAIs) system and Advanced Digital Data Sharing (ADDS) with Coaches
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2022to 31 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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).
- Conditions
- Binge Eating, Binge-Eating Disorder, Bulimia Nervosa, Bulimia
- Being tested
- Base self-help CBT program, Just-in-time, adaptive intervention (JITAIs) system, Advanced Digital Data Sharing (ADDS) with Coaches
- Keywords
- Cognitive behavior therapy, Self-help, Advanced Digital Data Sharing with Coaches, Just-in-time, adaptive interventions, Binge eating, Treatment
- Medical subject headings
- Bulimia, Binge-Eating Disorder, Bulimia Nervosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Base self-help CBT programBehavioural
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.
Just-in-time, adaptive intervention (JITAIs) systemBehavioural
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.
Advanced Digital Data Sharing (ADDS) with CoachesBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Base self-help CBT program plus Advanced Digital Data Sharing (ADDS) with Coaches | Experimental | 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. Receives: Behavioral: Base self-help CBT program; Behavioral: Advanced Digital Data Sharing (ADDS) with Coaches |
| Base self-help CBT program plus Just-in-time, adaptive interventions (JITAIs) | Experimental | 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. Receives: Behavioral: Base self-help CBT program; Behavioral: Just-in-time, adaptive intervention (JITAIs) system |
| Base self-help CBT program plus JITAIs plus Advanced Digital Data Sharing with Coaches | Experimental | 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. Receives: Behavioral: Base self-help CBT program; Behavioral: Just-in-time, adaptive intervention (JITAIs) system; Behavioral: Advanced Digital Data Sharing (ADDS) with Coaches |
| Base self-help cognitive behavior therapy (CBT) program | Active comparator | 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. Receives: Behavioral: Base self-help CBT program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
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.
Measured: 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
Frequency (number of days and number of instances) of compensatory behaviors assessed by the Eating Disorder Examination (EDE)
Measured: Changes from each assessment time point throughout treatment (3 assessments over 12 weeks) and at a 3 month post-treatment follow-up assessment
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.
Measured: 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
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.
Measured: Changes from each assessment time point throughout treatment after baseline so 2 assessments over 12 weeks (the mid-treatment and post-treatment assessments)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2023
- Study start1 Sep 2022
- Primary completion31 Aug 2025 (estimated)
- Study completion31 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Binge EatingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- 2\*2 factorial design
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Drexel University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05937243
- Sponsor's protocol ID
- 2205009229
- Acronym
- CONQUER
- Status last verified
- Aug 2024
- First submitted
- 20 Jun 2023
- Last updated
- 23 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05937243
- Acronym / sponsor ID
- CONQUER / 2205009229
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Drexel UniversityUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 10 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- 2*2 factorial design
| Arm | Type | Receives |
|---|---|---|
| Base self-help CBT program plus Advanced Digital Data Sharing (ADDS) with Coaches | Experimental | Behavioral: Base self-help CBT program, Behavioral: Advanced Digital Data Sharing (ADDS) with CoachesWhen 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) | Experimental | Behavioral: Base self-help CBT program, Behavioral: Just-in-time, adaptive intervention (JITAIs) systemWhen 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 | Experimental | Behavioral: Base self-help CBT program, Behavioral: Just-in-time, adaptive intervention (JITAIs) system, Behavioral: Advanced Digital Data Sharing (ADDS) with CoachesWhen 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 comparator | Behavioral: Base self-help CBT programThe 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 may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Base self-help CBT programThe 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. | Behavioural | Base self-help CBT program plus Advanced Digital Data Sharing (ADDS) with Coaches, Base self-help CBT program plus JITAIs plus Advanced Digital Data Sharing with Coaches, Base self-help CBT program plus Just-in-time, adaptive interventions (JITAIs), Base self-help cognitive behavior therapy (CBT) program |
| Just-in-time, adaptive intervention (JITAIs) systemWhen 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. | Behavioural | Base self-help CBT program plus JITAIs plus Advanced Digital Data Sharing with Coaches, Base self-help CBT program plus Just-in-time, adaptive interventions (JITAIs) |
| Advanced Digital Data Sharing (ADDS) with CoachesWhen 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. | Behavioural | Base self-help CBT program plus Advanced Digital Data Sharing (ADDS) with Coaches, Base self-help CBT program plus JITAIs plus Advanced Digital Data Sharing with Coaches |
Primary outcome
Binge eating frequency
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
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
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
The number of treatment modules completed will be captured from the smartphone application.
Rates of self-monitoring compliance
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
Number of data entries completed over the course of the treatment will be captured from the smartphone application.
Frequency of skills utilization
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
Number of times a therapeutic skills was used as indicated by participant on the self-monitored eating records and end-of-the-week surveys.
4 secondary outcomes
Severity of Global 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
Compensatory behavior frequency
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
Acceptability
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)
Acceptability and Feasibility
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2024.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Base self-help CBT program, Just-in-time, adaptive intervention (JITAIs) system and Advanced Digital Data Sharing (ADDS) with Coaches in people with Binge Eating and Binge-Eating Disorder, run by Drexel University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Binge eating frequency (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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2024.