Optimizing Digital Health Technology Interventions to Increase Skill Acquisition and Utilization

Optimizing Digital Health Technologies to Improve Therapeutic Skill Use and Acquisition

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).

Study Overview

• Status: Recruiting
• Conditions: Binge-Eating Disorder; Bulimia; Bulimia Nervosa; Binge Eating
• Intervention / Treatment: Behavioral: Behavioral Therapy for Eating Disorders; Behavioral: Skills Monitoring On; Behavioral: Automated Reminder Messages; Behavioral: JITAIs

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).

• Study Type: Interventional
• Enrollment (Estimated): 264
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sashi Govier, B.A.; Phone Number: 215-553-7100; Email: EDresearch@drexel.edu
• Study Contact Backup: Name: Adrienne Juarascio, Ph.D.; Phone Number: 4438018093; Email: asj32@drexe.edu

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • Drexel University, Stratton Hall
      • Contact: Research Coordinator; Phone Number: 215-553-7100; Email: EDresearch@drexel.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Base BT (Skills Monitoring Off + No Micro-Interventions); 16 weekly sessions of 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). This will include traditional self-monitoring of participants' eating patterns, binging, and (if applicable) compensatory behaviors via a smartphone application.	Behavioral: Behavioral 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).
Experimental: Base BT + Skills Monitoring On + No Micro-Interventions; 16 weekly sessions of 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). This will include 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.	Behavioral: Behavioral 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).; Behavioral: Skills 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.; Other Names: Enhanced Skills Monitoring
Experimental: Base BT + Skills Monitoring On + Automated Reminder Messages; 16 weekly sessions of 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).This will include 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. It will also include participants receiving two randomly time automated push notifications from the application each week to remind them about skills they have learned in session to encourage skill use.	Behavioral: Behavioral 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).; Behavioral: Skills 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.; Other Names: Enhanced Skills Monitoring; Behavioral: Automated 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.; Other Names: Micro-Intervention 1
Experimental: Base BT + Skills Monitoring On + JITAIs; 16 weekly sessions of 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). This will include 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. It will also include participants receiving push notifications each week to remind them 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).	Behavioral: Behavioral 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).; Behavioral: Skills 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.; Other Names: Enhanced Skills Monitoring; Behavioral: JITAIs; 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).; Other Names: Micro-Intervention 2
Experimental: Base BT + Skills Monitoring Off + Automated Reminder Messages; 16 weekly sessions of 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). This will include traditional self-monitoring of participants' eating patterns, binging, and (if applicable) compensatory behaviors via a smartphone application. It will also include participants receiving two randomly time automated push notifications from the application each week to remind them about skills they have learned in session to encourage skill use.	Behavioral: Behavioral 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).; Behavioral: Automated 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.; Other Names: Micro-Intervention 1
Experimental: Base BT + Skills Monitoring Off + JITAIs; 16 weekly sessions of 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). This will include traditional self-monitoring of participants' eating patterns, binging, and (if applicable) compensatory behaviors via a smartphone application. It will also include participants receiving push notifications each week to remind them 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).	Behavioral: Behavioral 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).; Behavioral: JITAIs; 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).; Other Names: Micro-Intervention 2

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Binge eating frequency assessed by the Eating Disorder Examination	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 16 weeks) and at a 6 month and a 12-month post-treatment follow-up assessment
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 16 weeks) and at a 6 month and a 12-month post-treatment follow-up assessment
Remission Status	Presence or absence of eating disorder diagnosis. Not in remission; in partial remission; or in full remission.	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
BMI	kilogram/(meters^2), this will be calculated by assessors when participants provide their height and weight at all assessment points	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compensatory behavior frequency assessed by the Eating Disorder Examination (EDE)	Frequency (number of days and number of instances) of compensatory behaviors assessed by the Eating Disorder Examination	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	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.	Changes from each assessment time point throughout treatment after baseline so 2 assessments over 16 weeks (the mid-treatment and post-treatment assessments).
Frequency of skill use and success of skill use	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).	Changes from each weekly session over the course of the 16 week treatment
Emotional Self-regulation	Changes in emotional self-regulation will be assessed using the total score of the Difficulties in Emotional Regulation Scale (DERS)	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 in impulsivity will be assessed by the total score of the UPPS-P Impulsive Behaviors Scale.	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

Collaborators and Investigators

• Sponsor: Drexel University
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Adrienne S Juarascio, Ph.D., Drexel University

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2023
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: July 18, 2022
• First Submitted That Met QC Criteria: July 21, 2022
• First Posted (Actual): July 25, 2022

Study Record Updates

• Last Update Posted (Actual): September 25, 2023
• Last Update Submitted That Met QC Criteria: September 21, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Bulimia Nervosa; Bulimia; Binge Eating; Eating disorders; Binge Eating Disorder; Cognitive Behavioral Treatment for Eating Disorders; Digital health technologies (DHTs); Micro-Interventions
• Additional Relevant MeSH Terms: Mental Disorders; Signs and Symptoms, Digestive; Hyperphagia; Bulimia; Feeding and Eating Disorders; Binge-Eating Disorder; Bulimia Nervosa
• Other Study ID Numbers: 2201009012; R01MH129478 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: We will follow all guidelines for data sharing through the National Database for Clinical Trials Related to Mental Illness (NDCT) and the NIMH Data Archive (NDA). 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: We will include supporting documentation to allow other researchers to use this data easily and appropriately.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No