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

NCT05567640 · Boston University Charles River Campus
In plain English

Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.

About this study
Kaiser Permanente (KP) members referred to SilverCloud Health (SC) through established operating procedures will be eligible to participate. After referral, potential participants will be informed of the study through the SC digital health platform. Interested participants will be provided information about the study through a digital version of an approved consent form. After signing consent, participants will complete baseline assessment questionnaires through Qualtrics, an online data collection platform. After completing the baseline assessment, eligible participants will be randomly assigned to one of three existing digital mental health interventions hosted by SC: (1) Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP), (2) Space from Depression (SFD), and (3) Space for Resilience (SFR). A SC program supporter will also be established at that time. This differs from standard operating procedures at SC in that participants are generally able to select their preferred program from SC's offerings. There is nothing that would preclude participants from seeking a different SC treatment following study participation. Potential participants will have up to two weeks to enroll in the study, complete the baseline assessment, and begin a treatment program. If the participant does not initiate treatment within two weeks, they will be withdrawn from the study though they may continue with clinical services at SC. Following randomization, study staff at BU will send participants Qualtrics questionnaires via email throughout the treatment phase of the study, at 4-, 8-, and 12-weeks after treatment is initiated. The participant completes these questionnaires online. Regular asynchronous written support will be provided by SC supporters, consistent with their standard procedures.
Eligibility criteria
Inclusion Criteria: * English-speaking adults * Ages 18 or older * Have a device that can connect to the internet.
Study design
Enrollment target: 1800 participants
Allocation: randomized
Masking: single
Age groups: adult, older_adult
Timeline
Starts: 2023-04-12
Estimated completion: 2027-07
Last updated: 2026-07-31
Interventions
Behavioral: The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP)Behavioral: Space for depressionBehavioral: Space for resilience
Primary outcomes
  • Change from baseline well-being at week 12 (Baseline, 4-weeks following baseline, 8-weeks following baseline, and 12-weeks following baseline)
Sponsor
Boston University Charles River Campus · other
With: National Institute of Mental Health (NIMH), Silver Cloud Health, Kaiser Permanente
Contacts & investigators
ContactTodd Farchione, Ph.D. · contact · tfarchio@bu.edu · (617) 353-9610
ContactAnthony Rosellini, Ph.D. · contact · ajrosell@bu.edu · (617) 353-9610
InvestigatorTodd Farchione, Ph.D. · principal_investigator, Boston University Charles River Campus
All locations (1)
Center for Anxiety and Related DisordersRecruiting
Boston, Massachusetts, United States
Using Machine Learning to Optimize User Engagement and Clinical Response to Digital Mental Health Interventions · TrialPath