Optimizing Digital Health Technology Interventions to Increase Skill Acquisition and Utilization
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorNemours Children's Clinic
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Are 18 to 65 years old.
Have experienced 12 or more loss of control episodes within the previous 3 months.
Have a BMI above 18.5.
Are located in the US and willing/able to participate in remote treatment and assessments.
Disqualifiers
Are unable to fluently speak, write and read English.
Have a BMI below 18.5.
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.
Are already receiving pharmacological or behavioral treatment for weight loss.
Trial design
Design model
Factorial
Treatments tested in this trial
Behavioral Therapy for Eating Disorders
BehavioralStandard 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).
Skills Monitoring On
BehavioralIntegrates 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.
Automated Reminder Messages
BehavioralIntegrates 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.
JITAIs
BehavioralIntegrates 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).
Treatment groups
264 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Group A: Base BT (Skills Monitoring Off + No Micro-Interventions)Active comparator 1 intervention
Group B: Base BT + Skills Monitoring On + No Micro-InterventionsExperimental treatment 2 interventions
Group C: Base BT + Skills Monitoring On + Automated Reminder MessagesExperimental treatment 3 interventions
Group D: Base BT + Skills Monitoring On + JITAIsExperimental treatment 3 interventions
Group E: Base BT + Skills Monitoring Off + Automated Reminder MessagesExperimental treatment 2 interventions
Group F: Base BT + Skills Monitoring Off + JITAIsExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
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
Time frame
Changes from each assessment time point throughout treatment (3 assessments over 16 weeks) and at a 6 month follow-up assessment2
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.
Time frame
Changes from each assessment time point throughout treatment (3 assessments over 16 weeks) and at a 6 month follow-up assessment3
Remission Status
Presence or absence of eating disorder diagnosis. Not in remission; in partial remission; or in full remission.
Time frame
Changes from each assessment time point throughout treatment (3 assessments over 16 weeks) and at a 6 month follow-up assessment4
BMI
kilogram/(meters\^2), this will be calculated by assessors when participants provide their height and weight at all assessment points
Time frame
Changes from each assessment time point throughout treatment (3 assessments over 16 weeks) and at a 6 month post-treatment follow-up assessmentSecondary outcomes
1
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
Time frame
Changes from each assessment time point throughout treatment (3 assessments over 16 weeks) and at a 6 month follow-up assessment2
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.
Time frame
Changes from each assessment time point throughout treatment after baseline so 2 assessments over 16 weeks (the mid-treatment and post-treatment assessments).3
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).
Time frame
Changes from each weekly session over the course of the 16 week treatment4
Emotional Self-regulation
Changes in emotional self-regulation will be assessed using the total score of the Difficulties in Emotional Regulation Scale (DERS)
Time frame
Changes from each assessment time point throughout treatment (3 assessments over 16 weeks) and at a 6 month follow-up assessmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Nemours Children's Clinic
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator
Source ClinicalTrials.gov