Binge Eating, Binge-Eating Disorder, Bulimia, Bulimia Nervosa
Conditions
Keywords
Eating disorders, Bulimia Nervosa, Bulimia, Binge Eating, Binge Eating Disorder, Cognitive Behavioral Treatment for Eating Disorders, Digital health technologies (DHTs), Micro-Interventions
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).
Interventions
BEHAVIORALBehavioral Therapy for Eating Disorders
Standard behavioral therapy for eating disorders aimed at changing behaviors that maintain binge eating (e.g. rigid dietary restriction outside of binge episodes, irregular or chaotic eating patterns).
BEHAVIORALSkills Monitoring On
Integrates behavioral treatment for eating disorders with a more complex self-monitoring than the self-monitoring protocol with traditional behavioral treatment. Via a smartphone application, participants will be asked to self-monitor skill usage of the skills provided during treatment sessions on top of monitoring their eating patterns, binging, and (if applicable) compensatory behaviors.
BEHAVIORALAutomated Reminder Messages
Integrates behavioral treatment for eating disorders with two randomly time automated push notifications from a smartphone application each week to remind participants about skills they have learned in session to encourage skill use.
BEHAVIORALJITAIs
Integrates behavioral treatment for eating disorders with push notifications each week from a smartphone application to remind participants about skills they have learned in session to encourage skill use during app-identified moments of need (i.e., JITAIs, just-in-time adaptive interventions).
Sponsors
Nemours Children's Clinic
National Institute of Mental Health (NIMH)
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
MOST: multiphase optimization strategy
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Are 18 to 65 years old. 2. Have experienced 12 or more loss of control episodes within the previous 3 months. 3. Have a BMI above 18.5. 4. Are located in the US and willing/able to participate in remote treatment and assessments. 5. Have a smartphone. 6. Complete the three-day app trial after the baseline assessment (i.e., the participant shows that they can self-monitor their episodes of eating three times a day for three days).
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 (e.g., research participants cannot be receiving concurrent eating disorder treatment in the clinical trial and from another provider). Participants willing to pause their existing eating disorder treatment for the duration of the clinical trial are eligible to participate. 4. Are already receiving pharmacological or behavioral treatment for weight loss. 5. If they meet the criteria for PCP clearance (see "Primary care physician clearance" section above) and are not deemed safe for outpatient treatment by a primary care physician. 6. If they meet the criteria for PCP clearance and are unwilling to receive medical clearance and/or medical monitoring as requested by the study to ensure they are medically safe to participate. 7. Have a mental handicap or are experiencing other severe psychopathology that would limit the research participants' ability to comply with the demands of the current study (e.g., imminent suicide risk, active psychotic disorder). Imminent suicide risk is assessed through the C-SSRS and a full risk assessment (see "Plan for assessing and/or intervening on suicidal ideation" above). Active psychotic disorder is assessed during the phone screen and with the standardized assessment checklist. 8. Are using a substance wherein the substance use is creating significant functional impairment that it is unlikely they can safely and effectively participate in an outpatient treatment study for eating pathology (i.e., the substance use: is interfering with day-to-day responsibilities and/or has gotten them in trouble with the law in the past year and/or has prevented them from attending/completing work and/or school within the past year) and/or if they are experiencing medical symptoms related to their substance use that requires immediate treatment and/or are unwilling or refrain from using the substances when it may interfere with treatment sessions and assessments (i.e., unwilling to not use the substances starting 2 hours prior to assessments and treatment sessions). Substance use is assessed during the phone screen and with the standardized assessment checklist. 9. Are pregnant or planning to become pregnant within the next year and a half.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Binge eating frequency assessed by the Eating Disorder Examination | Changes from each assessment time point throughout treatment (3 assessments over 16 weeks) and at a 6 month 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 | Changes from each assessment time point throughout treatment (3 assessments over 16 weeks) and at a 6 month 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 | Changes from each assessment time point throughout treatment (3 assessments over 16 weeks) and at a 6 month follow-up assessment | Presence or absence of eating disorder diagnosis. Not in remission; in partial remission; or in full remission. |
| BMI | Changes from each assessment time point throughout treatment (3 assessments over 16 weeks) and at a 6 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
| Measure | Time frame | Description |
|---|---|---|
| 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 follow-up assessment | Frequency (number of days and number of instances) of compensatory behaviors assessed by the Eating Disorder Examination |
| 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). | 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. 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 CBT+ technological features, including time, duration, and frequency of use. |
| Frequency of skill use and success of skill use | Changes from each weekly session over the course of the 16 week treatment | Data will be collected at each therapy session via a pre-session questionnaire for participants and post-session questionnaire for therapists to assess skills related to internal experiences such as urges and negative emotions that contribute to ED behaviors. The items were adapted from the Difficulties in Emotional Regulation Scale (DERS). |
| Emotional Self-regulation | Changes from each assessment time point throughout treatment (3 assessments over 16 weeks) and at a 6 month follow-up assessment | Changes in emotional self-regulation will be assessed using the total score of the Difficulties in Emotional Regulation Scale (DERS) |
| Self-regulation: Impulsivity | Changes from each assessment time point throughout treatment (3 assessments over 16 weeks) and at a 6 month follow-up assessment | Changes in impulsivity will be assessed by the total score of the UPPS-P Impulsive Behaviors Scale. |
Countries
United States
Contacts
CONTACTAdarsh Javvaji, B.A.
CONTACTStephanie Manasse, Ph.D.
PRINCIPAL_INVESTIGATORStephanie Manasse, Ph.D.
Nemours Children's Health
Outcome results
None listed