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

Completed · Not applicable

Conditions studied: Depression, Anxiety

In brief

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.

Key facts

Study ID: NCT05603923
Run by: University of Illinois at Chicago
People needed: 200
Starts: 2023-01-23
Expected to finish: 2025-04-15
Last updated by the study team: 2026-01-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Age: ≥ 18 years
Emotional distress defined by elevated depressive (PHQ-9 scores 10-19) and/or anxious symptoms (GAD-7 scores 10-14)
Willing and able to provide informed eConsent and HIPAA authorization

You may not qualify if…

Unable to speak, read, or understand English for informed consent
Current pharmacotherapy or psychotherapy (individual or professionally led group therapy) for depression or anxiety (note: participants are not withdrawn post-randomization if they begin pharmacotherapy drugs or start psychotherapy during the study.)
Suicidal ideation per PHQ-9 with active plan
Bipolar or psychotic disorder, or current psychiatric treatment
Weight ≥325 pounds due to brain scanner constraints, MRI contraindications, traumatic brain injuries, and tumor or any other known structural abnormality in the brain
Severe medical condition (e.g., myocardial infarction or stroke or new cancer diagnosis in the past 6 months, end-stage organ failure, terminal illness) or residence in a long-term care facility
Diagnosis of cancer (other than non-melanoma skin cancer) that is/was active or treated with radiation or chemotherapy within the past year
Active alcohol or substance use disorder (including prescription drugs) based on the CAGE Questionnaire Adapted to Include Drugs (CAGE-AID)
Cognitive impairment based on the Callahan 6-item screener
Current or planned pregnancy or lactating (<6 months postpartum)
Participation in other investigational treatment studies that would significantly affect participation in this study, raise safety concerns, and/or confound outcomes (participant may be asked to provide the informed consent of the other study for final decision on exclusion by a study psychiatrist)
Family/household member of an already enrolled participant or of a study team member
Plan to move out of the Chicago area during the study period
Does not have reliable Wi-Fi Internet at home
Unwillingness to user personal mobile device to receive study text messages
Investigator discretion for clinical safety or protocol adherence reasons

Where it is running

Department of Medicine, Vitoux Program on Aging and Prevention — Chicago, Illinois, United States
UIMC Advanced Imaging Center — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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