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NCT Number: NCT05473013

Optimizing Digital Health Technology Interventions to Increase Skill Acquisition and Utilization

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).

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Key information

Conditions

Bulimia Nervosa Binge Eating Binge-Eating Disorder Bulimia Feeding and Eating Disorders Hyperphagia Mental Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Drexel University, Stratton Hall

Philadelphia, Pennsylvania, 19104, United States

Location status: Recruiting

Location contact

Research Coordinator

CONTACT

[email protected]

215-553-7100

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Behavioral Therapy for Eating Disorders

Behavioral

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).

Skills Monitoring On

Behavioral

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

Automated Reminder Messages

Behavioral

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

JITAIs

Behavioral

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

Primary outcomes

  1. 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

  2. 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.

  3. 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.

  4. 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

  1. Compensatory behavior frequency assessed by the Eating Disorder Examination (EDE)

    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 compensatory behaviors assessed by the Eating Disorder Examination

  2. Acceptability and Feasibility

    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).

    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.

  3. Frequency of skill use and success of skill use

    Time frame: 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).

  4. Emotional Self-regulation

    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

    Changes in emotional self-regulation will be assessed using the total score of the Difficulties in Emotional Regulation Scale (DERS)

  5. Self-regulation: Impulsivity

    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

    Changes in impulsivity will be assessed by the total score of the UPPS-P Impulsive Behaviors Scale.

Study contacts

Contact information is provided by the study sponsor or research team.

Adrienne Juarascio, Ph.D.

CONTACT

[email protected]

4438018093

Sashi Govier, B.A.

CONTACT

[email protected]

215-553-7100

Sponsors and collaborators

Lead sponsor

Nemours Children's Clinic

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Optimizing Digital Health Technologies to Improve Therapeutic Skill Use and Acquisition

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Jul 25, 2022
Registry last updated
Aug 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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