study of a pst-trained voice-enabled artificial intelligence counselor(speac) for adults with emotional distress (phase 2)

Conditions: Depression; Anxiety

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.

all participants will complete measurements of neural target engagement and treatment outcomes at both baseline (0 week) and 18 weeks. study visit 1: this will include (1) physical measurements such as height, weight, and blood pressure, (2) functional magnetic resonance imaging (fmri) scan, (3) surveys of intervention-related measures, and (4) surveys of patient-reported outcomes, such as depressive and anxiety symptoms, social functioning, and health-related quality of life. following the successful completion of visit 1 and all the surveys, participants will be randomly assigned (by chance, like flipping a coin) to 1 of 3 study groups, as described below. problem solving treatment (pst) groups group 1: lumen coached group : participants assigned to this group will attend an intervention orientation session to receive the coach lumen tutorial, a study ipad, and a lumen intervention workbook. they will complete 8 pst sessions (4 weekly and then 4 biweekly) with coach lumen at home over 12 weeks. group 2: human coached group participants assigned to this group will receive a study ipad and human-coached intervention workbook, and will complete 8 pst sessions (4 weekly and then 4 biweekly) with a trained health coach over 12 weeks. they will complete the first session in person and then the remaining sessions via videoconference or phone. group 3: optional (delayed) lumen coached group participants assigned to this group may choose to attend a lumen orientation session to receive training and a study ipad to complete 8 pst sessions with coach lumen after completing their follow-up assessment at 18 weeks. regardless of the group assignment, participants will complete brief nightly mood check-in surveys about their thoughts, feelings, and experiences over the day, for 7 nights, approximately every other week over 18 weeks (i.e., a total of 58 nights). these check-ins are sent via text message to their mobile phone. study visit 2: regardless of group assignment, participants will be asked to attend a second in-person visit for data collection at 18 weeks. like visit 1, visit 2 will include physical measurements, a brain scan (after a negative pregnancy urine test, if applicable), and online surveys (if not yet completed before the visit), and will last approximately 90 minutes.

Eligibility criteria:
inclusion criteria: * 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 exclusion criteria: * 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