Using Machine Learning to Optimize User Engagement and Clinical Response to Digital Mental Health Interventions
2 other identifiers
interventional
1,800
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2023
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 13, 2022
CompletedFirst Posted
Study publicly available on registry
October 5, 2022
CompletedStudy Start
First participant enrolled
April 12, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2025
CompletedApril 14, 2023
April 1, 2023
2.3 years
September 13, 2022
April 13, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Change from baseline well-being at week 12
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).
Baseline, 4-weeks following baseline, 8-weeks following baseline, and 12-weeks following baseline
Secondary Outcomes (2)
Change from baseline anxiety at week 12
Baseline, 4-weeks following baseline, 8-weeks following baseline, and 12-weeks following baseline
Change in baseline depression at week 12
Baseline, 4-weeks following baseline, 8-weeks following baseline, and 12-weeks following baseline
Study Arms (3)
The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP)
EXPERIMENTALDigital, transdiagnostic, emotion-focused CBT intervention that consists of five "core" modules or components that have been shown to target temperamental characteristics (i.e., neuroticism) and resulting emotion dysregulation that are believed to underlie all anxiety, depressive, and emotional disorders. The core components of the program are psychoeducation, mindfulness, cognitive flexibility, behavioral strategies to counter emotion-driven behaviors, interoceptive, and emotion exposures.
Space from Depression (SFD)
ACTIVE COMPARATORDigital CBT program designed to minimize the impact of depressive symptoms. This program emphasizes the use of cognitive behavioral strategies as well as mindfulness through a series of seven structured modules. The core components of the program include psychoeducation around the relationship between thoughts, feelings, and behaviors; cognitive behavioral practices aimed at restructuring negative beliefs; behavioral strategies to improve self-esteem; and mindfulness techniques that focus attention on the present moment.
Space for Resilience (SFR)
ACTIVE COMPARATORDigital program based on positive psychology principles and designed to promote resilience and well-being through a series of seven modules. The core components of the program include psychoeducation, values exploration, building relationships, promoting self-esteem and self-efficacy, and building gratitude and optimism.
Interventions
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.
Digital CBT program designed to minimize the impact of depression symptoms. Emphasizes CBT strategies and mindfulness through a series of seven structured modules.
This program is built from positive psychology principles and is designed to promote resilience and well-being through seven modules.
Eligibility Criteria
You may qualify if:
- English-speaking adults
- Ages 18 or older
- Have a device that can connect to the internet.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Boston University Charles River Campuslead
- National Institute of Mental Health (NIMH)collaborator
- Silver Cloud Healthcollaborator
- Kaiser Permanentecollaborator
Study Sites (1)
Center for Anxiety and Related Disorders
Boston, Massachusetts, 02115, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 13, 2022
First Posted
October 5, 2022
Study Start
April 12, 2023
Primary Completion
July 31, 2025
Study Completion
July 31, 2025
Last Updated
April 14, 2023
Record last verified: 2023-04