โš ๏ธ Medical Notice: If you are experiencing a medical emergency, call 911 or go to the nearest ER. This directory is an educational resource and not an emergency medical service.
๐Ÿ›๏ธ Verified NIH Protocol โ€ข Sourced via U.S. National Library of Medicine (Last Synced: 2026-07-31)

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

๐ŸŸข Recruiting Protocol / Phase N/A ๐Ÿง  Behavioral & Telehealth Program Sponsor: Boston University Charles River Campus

๐Ÿฉบ Protocol Summary

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.

Primary Research Facility: Center for Anxiety and Related Disorders (Boston, Massachusetts)

๐Ÿ“‹ Preliminary Self-Screener

0 of 3 Answered

Answer all 3 basic criteria below to see your preliminary screening result:

๐Ÿ“ Primary Site Map

Site: Center for Anxiety and Related Disorders โ€” Boston, Massachusetts

๐Ÿ“„ Print Doctor Discussion Sheet

Preview and print a 1-page summary with 5 tailored questions for your physician.

๐Ÿ’ฐ Clinical Trial Costs & Insurance Coverage

Coverage for clinical trial participation varies depending on your health insurance policy, state legislation, and whether specific procedures are investigational research or routine medical care. Under federal law (Affordable Care Act ยง 2709), health insurers generally cannot drop coverage or refuse to pay for routine patient care costs incurred in approved clinical trials.

๐Ÿ’ก Always ask the study coordinator for the trial's official Informed Consent Form, which outlines all sponsor-funded research items versus procedures billed to your insurance.

๐Ÿ›๏ธ Official Government Provenance

NIH ClinicalTrials.gov Protocol Record

NCT Identifier: NCT05567640 โ€ข Last Synced: 2026-07-31
View on ClinicalTrials.gov โ†—
๐Ÿ“ž Call Desk ๐Ÿ“‹ Check Eligibility