Optimizing Digital Health Technology Interventions to Increase Skill Acquisition and Utilization

NCT05473013 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 264

Last updated 2023-09-25

No results posted yet for this study

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).

Conditions

  • Bulimia Nervosa
  • Bulimia
  • Binge Eating
  • Binge-Eating Disorder

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.

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.

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).

Sponsors & Collaborators

  • National Institute of Mental Health (NIMH)

    collaborator NIH
  • Drexel University

    lead OTHER

Principal Investigators

  • Adrienne S Juarascio, Ph.D. · Drexel University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-06
Primary Completion
2025-12-31
Completion
2026-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05473013 on ClinicalTrials.gov