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

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen byJun Ma, MD, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of Illinois at Chicago

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Jun Ma, MD, PhD

Principal Investigator

University of Illinois at Chicago

Eligibility Criteria

Inclusion Criteria

Emotional distress defined by elevated depressive (PHQ9 scores 10-19) and/or anxious symptoms (GAD7 scores 10-14)

Willing and able to provide written informed consent and HIPAA authorization

18 years of age or older at study enrollment

Treatment Details

Interventions

Lumen Treatment (Artificial Intelligence)

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: Lumen treatmentExperimental Treatment1 Intervention

Participants will complete functional magnetic resonance imaging (fMRI) and self-report questionnaires at baseline and 16 weeks. Participant will receive an encrypted study iPad enabled with Lumen at baseline. They will complete 8 PST sessions beginning with 4 weekly and then 4 biweekly intervals (i.e., on weeks 1, 2, 3, 4, 6, 8, 10, 12) over 12 weeks on their assigned iPad. Participants will also complete naturalistic end-of-day assessments for 7 days every 2 weeks (on weeks 0, 2, 4, 6, 8, 10, 12, 16), that is, 8 time series. Additionally, participants will complete depressive and anxiety symptoms questionnaire and user experience surveys at all PST sessions.

Group II: Waitlist ControlActive Control1 Intervention

Participants will complete functional magnetic resonance imaging (fMRI) and self-report questionnaires at Baseline and 16 weeks. Participant will receive an encrypted study iPad at baseline. Participants will complete naturalistic end-of-day assessments for 7 days every 2 weeks (on weeks 0, 2, 4, 6, 8, 10, 12, 16), that is, 8 time series. Participants in the waitlist control arm will only complete assessments but 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.