Optimizing Digital Health Technologies to Improve Therapeutic Skill Use and Acquisition
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Bulimia Nervosa
- Sponsor
- Drexel University
- Enrollment
- 264
- Locations
- 1
- Primary Endpoint
- Binge eating frequency assessed by the Eating Disorder Examination
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
The purpose of this study is to identify the independent and combined effects of two types of self-monitoring and two types of micro-interventions when combined with standard cognitive behavioral treatment for bulimia nervosa (BN) and binge eating disorder (BED). The primary aims of this study are (1) to evaluate the optimal complexity of Self-Monitoring and Micro-Interventions on eating pathology (at post-treatment and at 6 and 12-month follow-ups and (2) to test the hypotheses that the optimal complexity level of each component is moderated by baseline deficits in self-regulation. The secondary aim will be to test target engagement for each level of complexity for each component, i.e., to test whether higher complexity of each technological components is associated with better rates of therapeutic skill use and acquisition and that improvements in skill use and acquisition are associated with improvements in outcomes. A final exploratory aim will be to quantify the component interaction effects, which may be partially additive (because components overlap and/or there is diminishing return), fully additive, or synergistic (in that component complexities may partially depend on each other).
Detailed Description
The current study will use a 2 x 3 full factorial design in which 264 individuals with BN or BED are assigned to one of six treatment conditions, i.e., representing each permutation of self-monitoring complexity (Skills-Monitoring On vs. Skills-Monitoring Off) and micro-intervention complexity (No Micro-Interventions vs. Automated Reminder Messages vs. JITAIs) as an augmentation to CBT. All participants will be given the gold-standard treatment for eating disorders known as cognitive behavioral therapy (CBT-E) which is the most evidence-based treatment to date for eating disorders and is a well-established treatment approach. The main innovation of the new proposed study is the evaluation of the efficacy of the six intervention conditions that arise as a result of testing each possible combination of self-monitoring complexity (Skills-Monitoring On vs. Skills-Monitoring Off) and micro-intervention complexity (No Micro-Interventions vs. Automated Reminder Messages vs. JITAIs) as an augmentation to CBT. The purpose of this study is to identify the independent and combined effects of two types of self-monitoring and two types of micro-interventions when combined with standard cognitive behavioral treatment for bulimia nervosa (BN) and binge eating disorder (BED). The primary aims of this study are (1) to evaluate the optimal complexity of Self-Monitoring and Micro-Interventions on eating pathology (at post-treatment and at 6 and 12-month follow-ups and (2) to test the hypotheses that the optimal complexity level of each component is moderated by baseline deficits in self-regulation. The secondary aim will be to test target engagement for each level of complexity for each component, i.e., to test whether higher complexity of each technological components is associated with better rates of therapeutic skill use and acquisition and that improvements in skill use and acquisition are associated with improvements in outcomes. A final exploratory aim will be to quantify the component interaction effects, which may be partially additive (because components overlap and/or there is diminishing return), fully additive, or synergistic (in that component complexities may partially depend on each other).
Investigators
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
Outcomes
Primary Outcomes
Binge eating frequency assessed by the Eating Disorder Examination
Time Frame: Changes from each assessment time point throughout treatment (3 assessments over 16 weeks) and at a 6 month and a 12-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
Global Eating Pathology
Time Frame: Changes from each assessment time point throughout treatment (3 assessments over 16 weeks) and at a 6 month and a 12-month post-treatment follow-up assessment
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.
Remission Status
Time Frame: Changes from each assessment time point throughout treatment (3 assessments over 16 weeks) and at a 6 month and a 12-month post-treatment follow-up assessment
Presence or absence of eating disorder diagnosis. Not in remission; in partial remission; or in full remission.
BMI
Time Frame: Changes from each assessment time point throughout treatment (3 assessments over 16 weeks) and at a 6 month and a 12-month post-treatment follow-up assessment
kilogram/(meters\^2), this will be calculated by assessors when participants provide their height and weight at all assessment points
Secondary Outcomes
- Compensatory behavior frequency assessed by the Eating Disorder Examination (EDE)(Changes from each assessment time point throughout treatment (3 assessments over 16 weeks) and at a 6 month and a 12-month post-treatment follow-up assessment)
- Self-regulation: Impulsivity(Changes from each assessment time point throughout treatment (3 assessments over 16 weeks) and at a 6 month and a 12-month post-treatment follow-up assessment)
- Acceptability and Feasibility(Changes from each assessment time point throughout treatment after baseline so 2 assessments over 16 weeks (the mid-treatment and post-treatment assessments).)
- Emotional Self-regulation(Changes from each assessment time point throughout treatment (3 assessments over 16 weeks) and at a 6 month and a 12-month post-treatment follow-up assessment)
- Frequency of skill use and success of skill use(Changes from each weekly session over the course of the 16 week treatment)