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Study of a PST-Trained Voice-Enabled Artificial Intelligence Counselor(SPEAC) for Adults With Emotional Distress (Phase 2)

Study acronym: SPEAC
StatusCompleted
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Results posted: Sep 23, 2026 Eligibility criteria expanded, about 19 words · Secondary endpoints revised (10) · Primary endpoint revised · 1 more Show 4 more changesShow less
    • Eligibility criteria expanded, about 19 words
    • Secondary endpoints revised (10)
    • Primary endpoint revised
    • Publications: details revised at 2 of 2 entries
  2. Secondary endpoints: 1 to 10v7 See this version in full on ClinicalTrials.gov ↗
  3. Trial status: Active, Not Recruiting to Completed Primary completion date changed from estimate of May 7, 2025 to Apr 15, 2025 · Study completion date changed from estimate of Jul 2, 2025 to Apr 15, 2025v6 Show 2 more changesShow less
    • Primary completion date changed from estimate of May 7, 2025 to Apr 15, 2025
    • Study completion date changed from estimate of Jul 2, 2025 to Apr 15, 2025
  4. Trial status: Recruiting to Active, Not Recruiting Primary completion date: Dec 30, 2024 to May 7, 2025 · Site details revised at 2 of 2 sitesv5 Show 2 more changesShow less
    • Primary completion date: Dec 30, 2024 to May 7, 2025
    • Site details revised at 2 of 2 sites
  5. Re-verified, no change to tracked fieldsv4
Show 2 earlier versionsHide 2 earlier versions
  1. Primary completion date: Dec 2024 to Dec 30, 2024 Completion date: Jul 2025 to Jul 2, 2025v3 Show 1 more changeShow less
    • Completion date: Jul 2025 to Jul 2, 2025
  2. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Jan 2023 to Jan 23, 2023 · Site details revised at 2 of 2 sitesv2 Show 2 more changesShow less
    • Start date changed from estimate of Jan 2023 to Jan 23, 2023
    • Site details revised at 2 of 2 sites
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05603923
Lead Sponsor University of Illinois at Chicago
Collaborators: Penn State University, Washington University School of Medicine, Stanford University, National Institute of Mental Health (NIMH)
Conditions Depression, Anxiety
Enrollment 200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov