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

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.

Inclusion Criteria:Age: ≥ 18 yearsEmotional 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 authorizationExclusion Criteria:Unable to speak, read, or understand English for informed consentCurrent 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or psychotherapy (individual or professionally led group therapy) for depression or anxiety (note: participants are not withdrawn post-randomization if they begin pharmacotherapy drugs or start psychotherapy during the study.)Suicidal ideation per PHQ-9 with active planBipolar or psychotic disorder, or current psychiatric treatmentWeight ≥325 pounds due to brain scanner constraints, MRI contraindications, traumatic brain injuries, and tumor or any other known structural abnormality in the brainSevere 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 facilityDiagnosis of cancer (other than non-melanoma skin cancer) that is/was active or treated with radiation or chemotherapy within the past yearActive 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 screenerCurrent 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 memberPlan to move out of the Chicago area during the study periodDoes not have reliable Wi-Fi Internet at homeUnwillingness to user personal mobile device to receive study text messagesInvestigator discretion for clinical safety or protocol adherence reasons