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

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.

Conditions

• Depression
• Anxiety

Interventions

BEHAVIORAL

Lumen Coached PST Intervention.

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.

BEHAVIORAL

Human Coached PST Intervention.

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.

BEHAVIORAL

Optional (delayed) Lumen Coached PST (Waitlist control).

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.

Sponsors & Collaborators

• Penn State University

  collaborator OTHER

• Washington University School of Medicine

  collaborator OTHER

• Stanford University

  collaborator OTHER

• National Institute of Mental Health (NIMH)

  collaborator NIH

• University of Illinois at Chicago

  lead OTHER

Principal Investigators

• Jun Ma, MD, PhD · University of Illinois at Chicago

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-01-23

Primary Completion

2025-04-15

Completion

2025-04-15

Countries

• United States

Study Locations