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Using Machine Learning to Optimize User Engagement and Clinical Response to Digital Mental Health Interventions

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Notable Primary and study completion dates: Jul 31, 2025 to Jul 2027v4
  2. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Feb 1, 2023 to Apr 12, 2023
    • Site details revised
    v3
  3. Notable Start date: Nov 1, 2022 to Feb 1, 2023
    • Interventions: Digital Interventions (Other) to Space for depression (Behavioral), Space for resilience (Behavioral), The Unified Protocol for Transdiagnostic Treatment of Emotional…
    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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Digital mental health interventions are a cost-effective and efficient approach to expanding the accessibility and impact of psychological treatments; however, little guidance exists for selecting the most effective program for a given individual. In the proposed study, decision rules will develop for selecting the digital program that is most likely to be the optimal intervention for each user. These treatment recommendations can be implemented in the context of large healthcare delivery systems to improve the delivery of digital mental health interventions at scale. The overarching aim of the current study is to better understand for whom and how leading digital interventions work in a large healthcare setting. The study builds on the existing literature and follows expert recommendations by using machine learning (ML) methods to develop precision treatment rules (PTRs) for three leading digital interventions for emotional disorders (e.g., anxiety, depression, and related mental health disorders). Specifically, ML methods will be used to develop PTRs to optimize clinical outcomes and associated intervention engagement. This study will leverage a unique partnership between Boston University (BU), SilverCloud Health (SC)--a leading provider of digital mental health care--and Kaiser Permanente (KP)--one of America's leading health care providers. A clinical trial (RCT) will be conducted to evaluate the relative effectiveness of three distinct empirically supported digital mental health interventions (from SC's existing library of programs) in a sample recruited from KP primary care and other clinical settings. Data from this trial will be used to develop theoretically and empirically informed, reliable selection algorithms for managing treatment delivery decisions. Algorithms will be validated in a separate "holdout" dataset by examining whether allocation to predicted optimal treatment is associated with superior outcomes compared to allocation to a non-optimal treatment. The role of user engagement will be determined, and other mechanisms in treatment outcome.
Trial Details
NCT Number NCT05567640
Lead Sponsor Boston University Charles River Campus
Collaborators: National Institute of Mental Health (NIMH), Silver Cloud Health, Kaiser Permanente
Conditions
(from sponsor)
Anxiety Disorders and Symptoms, Depressive Symptoms
Related terms Anxiety Disorders, Depression
Enrollment 1,800 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov