Study of a PST-Trained Voice-Enabled Artificial Intelligence Counselor(SPEAC) for Adults With Emotional Distress (Phase 2)
Trial ID: NCT05603923
Status: COMPLETED
Study type: INTERVENTIONAL
Phase: NA
Start date: 2023-01-23
Completion date: 2025-04-15
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
Interventions: Lumen Coached PST Intervention.; Human Coached PST Intervention.; Optional (delayed) Lumen Coached PST (Waitlist control).
Locations: Department of Medicine, Vitoux Program on Aging and Prevention; UIMC Advanced Imaging Center
Countries: United States; United States
Enrollment: 200
Age range: 18 Years - None
Sex: ALL

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.

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or psychotherapy (individual or professionally led group therapy) for depression or anxiety (note: participants are not withdrawn post-randomization if they begin pharmacotherapy drugs or start psychotherapy during the study.)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

Outcomes:
Change from Baseline Functional Magnetic Resonance Scan at 18 weeks