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Optimizing Digital Health Technology Interventions to Increase Skill Acquisition and Utilization

StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Minor Eligibility criteria expanded, about 295 words
    • Secondary endpoints: details revised at 3 of 5 entries
    • Study site revised
    v4
  2. Notable Lead sponsor: Drexel University to Nemours Children's Clinic
    • Primary completion date: Dec 2025 to Jan 2027
    • Study completion date: Mar 2026 to Jan 2027
    v3
  3. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Dec 2022 to Jan 6, 2023
    • Site details revised
    v2
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
Trial Details
NCT Number NCT05473013
Lead Sponsor Nemours Children's Clinic
Collaborators: National Institute of Mental Health (NIMH)
Conditions
(from sponsor)
Bulimia Nervosa, Bulimia, Binge Eating, Binge-Eating Disorder
Related terms Binge-Eating Disorder, Bulimia, Bulimia Nervosa, Feeding and Eating Disorders
Enrollment 264 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov