Life sciences · Interventional Study
ClinicalTrials.gov · September 23, 2026
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Interventional Study.
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Registry record from ClinicalTrials.gov (NCT05603923). This is a study registration, not published results. Lead sponsor: University of Illinois at Chicago. Recruitment status: COMPLETED. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 200 participants (ACTUAL). Conditions: Depression, Anxiety. Interventions: BEHAVIORAL: Lumen Coached PST Intervention.; BEHAVIORAL: Human Coached PST Intervention.; BEHAVIORAL: Optional (delayed) Lumen Coached PST (Waitlist control).. Primary outcome measures: Change From Baseline Functional Magnetic Resonance Scan at 18 Weeks , Baseline, 18 weeks. Brief summary: Approximately 200 Participants with mild-to-moderate, untreated depression and/or anxiety will be randomly assigned (by chance, like flipping a coin) to 1 of 3 study groups: Lumen Coached Problem-Solving Treatment (PST) (n=100), Human Coached PST (n=50), and optional (delayed) Lumen Coached PST as waitlist control (n=50) to improve emotional health. All participants will complete assessments at baseline and at 18 weeks post randomization. Depending on the group assignment the PST program will be delivered by Lumen, a virtual voice-based coach on a study iPad, or by a human coach in person for the first session and then via videoconference or phone for the remaining 7 sessions. Participants assigned to the waitlist control group can receive the Lumen coached PST on a study iPad after completing their 18-week follow-up assessment. Participants will receive 8 coaching sessions to learn problem-solving skills and work on unresolved problems in daily living that may be interfering with their emotional well-being and contributing to depression and anxiety symptoms.