NCT05567640 · Boston University Charles River Campus
Using Machine Learning to Optimize User Engagement and Clinical Response to Digital Mental Health Interventions
What this study is about
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.
View original scientific description
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.
Interventions
BEHAVIORAL
The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP)
This is a cognitive behavioral treatment (CBT) for emotional disorders. This transdiagnostic intervention consists of eight modules and can be effectively applied to various disorders and problems.
BEHAVIORAL
Space for depression
Digital CBT program designed to minimize the impact of depression symptoms. Emphasizes CBT strategies and mindfulness through a series of seven structured modules.
BEHAVIORAL
Space for resilience
This program is built from positive psychology principles and is designed to promote resilience and well-being through seven modules.
Primary outcome measures
Change from baseline well-being at week 12
Time frame: Baseline, 4-weeks following baseline, 8-weeks following baseline, and 12-weeks following baseline
World Health Organization-Five (WHO-5) is a 5-item self-report questionnaire of psychological well being. The WHO-5 has demonstrated good validity and utility as an outcome measure in clinical trials including several digital intervention trials. Respondents rate each statement in relation to the past two weeks on a scale ranging from 0= At no time to 5= All the time (Ware, 1995).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- English-speaking adults
- Ages 18 or older
- Have a device that can connect to the internet.
Where
- Boston, Massachusetts
Collaborators
National Institute of Mental Health (NIMH), Silver Cloud Health, Kaiser Permanente
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 31, 2026 · Source of record for eligibility and locations