NCT04524104

Study of a PST-Trained Voice-Enabled Artificial Intelligence Counselor (SPEAC) for Adults With Emotional Distress (Phase 1)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: University of Illinois at Chicago · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

In the phase 1 of the SPEAC project the specific aims are to: (1) establish the functionality, usability, and treatment fidelity of Lumen using iterative, user-centered design, development, and formative evaluation; and (2) demonstrate feasibility, acceptability, and target engagement in a 2-arm pilot RCT. The aim 1 focuses on developing a voice-enabled, artificial intelligence (AI) virtual agent, named Lumen, trained in Problem Solving Therapy (PST) via an iPad-based application. The development of Lumen will employ iterative user-centered design-evaluation cycles. After the functionality, usability and treatment fidelity of Lumen are established, in the aim 2, we will conduct a 2-arm randomized clinical trial (RCT, Study 1) to pilot test Lumen.

Detailed description

60 participants with eligible depression and/or anxiety (n=60) will be randomized in a 2:1 ratio to the Lumen treatment arm (n=40) or the wait-list control arm (n=20). Participants in both arms will receive encrypted study iPads. Lumen treatment arm participants will receive encrypted study iPads to complete PST with Lumen (8 sessions, 4 weekly and then 4 biweekly, over 12 weeks) or be on a wait list. Participant permission will be obtained to record their PST sessions with Lumen, which will be independently rated by PST experts for fidelity. Lumen treatment arm participants will also complete the depressive and anxiety symptoms assessment questionnaires at the start of each PST session, and a participant survey of usability, user experience and therapeutic alliance at the end of each PST session. Participants in both arms will complete measurements of neural target engagement and treatment outcomes at both baseline (0 week) and 16 weeks. These assessments will include (1) functional magnetic resonance imaging (fMRI) 2) Surveys of PST (3) Surveys of patient-reported outcomes, such as depressive and anxiety symptoms, social functioning, and health-related quality of life. Participants also will complete naturalistic end-of-day assessments of mood, stress, appraisal, and coping for 7 days every 2 weeks (on weeks 0, 2, 4, 6, 8, 10, 12, 16) - that is, 8 time series. Participants in the wait-list control arm will have the option to receive Lumen at the end of the study. The PST module on the study iPad will be disabled until their 16-week assessment is completed, at which time they will have the option to complete 8 PST sessions on their assigned iPads.

Conditions

• Depression
• Anxiety

Interventions

Type	Name	Description
BEHAVIORAL	Lumen Treatment	the virtual AI agent, Lumen, via an iPad-based application. Each participant will receive a locked, encrypted study iPad installed with Lumen. They will complete 8 problem solving therapy (PST) sessions beginning with 4 weekly and then 4 biweekly intervals over 12 weeks on their assigned iPad.

Timeline

• Start date: 2021-04-05
• Primary completion: 2022-02-08
• Completion: 2022-03-05
• First posted: 2020-08-24
• Last updated: 2024-07-09
• Results posted: 2023-06-28

Locations

2 sites across 1 country: United States