Bulimia Nervosa Clinical Trial
— CONQUEROfficial 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
Verified date | July 2023 |
Source | Drexel University |
Contact | Paakhi Srivastava |
Phone | 2678156511 |
ps887[@]drexel.edu | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Recruiting |
Enrollment | 76 |
Est. completion date | August 31, 2025 |
Est. primary completion date | August 31, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: 1. Have experienced 12 or more loss of control episodes within the previous 3 months 2. Have a BMI at or above 18.5 3. Are located in the US and willing/able to participate in treatment and assessments 4. Are able to give consent Exclusion Criteria: 1. Are unable to fluently speak, write and read English 2. Have a BMI below 18.5 3. Are already receiving treatment for an eating disorder 4. Require immediate treatment for medical complications as a result of eating disorder symptoms 5. 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) 6. Are pregnant or are planning to become pregnant |
Country | Name | City | State |
---|---|---|---|
United States | Drexel University | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Drexel University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | 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. | Changes from each assessment time point throughout treatment (3 assessments over 12 weeks) and at a 3 month post-treatment follow-up assessment | |
Secondary | Compensatory behavior frequency | Frequency (number of days and number of instances) of compensatory behaviors assessed by the Eating Disorder Examination (EDE) | Changes from each assessment time point throughout treatment (3 assessments over 12 weeks) and at a 3 month post-treatment follow-up assessment | |
Secondary | 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. | Changes from each assessment time point throughout treatment after baseline so 2 assessments over 12 weeks (the mid-treatment and post-treatment assessments) | |
Secondary | 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. | Changes from each assessment time point throughout treatment after baseline so 2 assessments over 12 weeks (the mid-treatment and post-treatment assessments) |
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