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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Depression, Anxiety

Intervention / Treatment
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* Behavioral: Lumen Coached PST Intervention.
* Behavioral: Human Coached PST Intervention.
* Behavioral: Optional (delayed) Lumen Coached PST (Waitlist control).


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1: Lumen Coached Group<br>Participants in 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 with Coach Lumen using their study assigned iPad at home over 12 weeks. The first 4 sessions occur weekly and then the last 4 occur every other week. Participants will receive automated reminders on the day before and on the day of their scheduled session, and have the opportunity to reschedule sessions through the iPad. Participants will work with Coach Lumen to learn problem-solving skills to address current life challenges, plan activities, and complete home activities. Participants will also complete surveys before and after each PST session: a mood assessment survey before and a user experience survey after. At the end of study, Participants may be invited to provide their perspective regarding their Lumen use experience. | Behavioral: Lumen Coached PST Intervention.<br>* Lumen Intervention Orientation. Participants in the Lumen intervention arm attend a Lumen orientation visit (60 minutes) during which they will be given a Lumen intervention tutorial and receive a study iPad, configured to limit access to only the Lumen intervention enabled on the device. Before leaving, participants are scheduled for the first PST session with Coach Lumen. At the end of each PST session, participants are prompted to schedule their next session with Coach Lumen. They receive automated reminder notifications 1 day prior to their next session, on the session day, and have the opportunity to make up missed sessions. As needed, Lumen intervention orientations can be done remotely.<br>|
| Active Comparator: Group 2: Human Coached Group<br>Participants in this group will receive a study iPad and Human-Coached Intervention Workbook and will complete the first of 8 PST sessions in person with a trained health coach. Participants' first PST session will be in person for approximately 1 hour. Participants will complete the remaining sessions remotely via Zoom (or by phone, if necessary) using their study iPad. The first 4 sessions occur weekly and then the last 4 occur every other week. Participants will receive automated reminder notifications on the day before and on the day of their scheduled session, and have the opportunity to reschedule sessions with their coach. Participants will also complete a mood assessment survey at the beginning of each PST session. Participants will work with their health coach to learn problem-solving skills to address current life challenges, plan activities, and complete home activities. | Behavioral: Human Coached PST Intervention.<br>* Participants in the human coached PST arm will serve as active treatment controls given the demonstrated efficacy of human coached PST in depression and anxiety. They will complete 8 PST sessions with a human coach; first session in-person and remaining sessions via videoconferencing (i.e., Zoom preferred; with phone calls allowed) on the same 4 weekly and then 4 biweekly schedule as that for Lumen participants. Participants will receive a study iPad to use for their PST sessions via zoom. Participants also complete the PHQ-9 and GAD-7 during each session. Participants will receive a certificate of completion.<br>|
| Placebo Comparator: Group 3: Optional (Delayed) Lumen Coached Group<br>Participants assigned to this group can choose to attend a Lumen Orientation session to receive training and a study iPad to complete 8 PST sessions with Coach Lumen after their follow-up assessment at 18 weeks. They will receive 8 Sunday mood assessment surveys to complete (4 every Sunday and then 4 every other Sunday). | Behavioral: Optional (delayed) Lumen Coached PST (Waitlist control).<br>* Waitlist control participants will only complete assessments during the 18-week trial period. At the end of their 18-week assessment, they will have the option to complete 8 PST sessions on their assigned iPads.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline Functional Magnetic Resonance Scan at 18 weeks | Outcome Description Two neural targets defined a priori, specifically activation of the amygdala for nonconscious threat-related emotional reactivity and activation of the DLPFC for cognitive control will be assessed using fMRI. In the facial emotion viewing paradigm, facial expression stimuli are standardized black and white photographs of 8 identities (4 female, 4 male) with evoked expressions of threat-related emotions (fear, anger), loss-related emotions (sadness) and reward-related emotions (happiness), along with neutral. For the Go-NoGo paradigm, the 'Go' and 'NoGo' stimuli are presented for 500 ms each with an inter-stimulus interval of 750 ms. The 2 paradigms are empirically validated probes of emotional reactivity and cognitive control, respectively. | Baseline, 18 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline Penn State Worry Questionnaire (PSWQ) at 18 weeks | Outcome Description PSWQ is a self-reported, 16-item, Likert-type scale that measures the trait of worry. Cronbach's alpha is 0.93-0.95 and test-retest correlation is 0.92 after 8-10 weeks. In addition, PSWQ significantly discriminates levels of generalized anxiety disorder (GAD) and GAD versus PTSD. | Baseline, 18 weeks |