# Study of a PST-Trained Voice-Enabled Artificial Intelligence Counselor (SPEAC) for Adults with Emotional Distress

> **NIH NIH R33** · UNIVERSITY OF ILLINOIS AT CHICAGO · 2024 · $920,725

## Abstract

PROJECT SUMMARY
BACKGROUND: Depression and anxiety are the leading causes of disability and lost productivity, and are
often underdiagnosed and undertreated owing to access, cost, and stigma barriers. Novel and scalable
psychotherapies are urgently needed. Advances in artificial intelligence (AI) offer a transformative opportunity
to develop intelligent voice assistants as virtual health agents accessible on personal devices. Meanwhile,
major advances in human neuroscience have fueled a paradigm shift to study brain mechanisms underlying
behavioral health interventions. OBJECTIVES: Leveraging our collaborative team’s transdisciplinary expertise
in these emerging areas, we will develop and rigorously test a novel voice-enabled, AI virtual agent named
Lumen, trained on Problem Solving Therapy (PST), for patients with moderate, untreated depressive and/or
anxiety symptoms. We will investigate the effect of Lumen on engagement of a priori neural targets—amygdala
for emotional reactivity and dorsal lateral prefrontal cortex (DLPFC) for cognitive control—as putative
mechanisms. DESIGN/ METHODS: The project has 2 phases. In the R61 phase (years 1-2), we will further
develop Lumen building on the current prototype and conduct iterative user-centered design evaluations that
include focus groups, scenario-based clinician evaluations, and a formative user study with 20 participants. We
will pilot test Lumen in a 2-arm randomized clinical trial (RCT, Study 1), with 60 participants with depression
and/or anxiety randomized in a 2:1 ratio to receive PST with Lumen (n=40) on a secure study iPad or be on a
waitlist (n=20). At weeks 0 and 14, participants will complete functional magnetic resonance imaging (fMRI) to
assess neural target engagement as well as validated surveys of patient-reported outcomes (e.g., depressive
and anxiety symptoms, functioning, quality of life). In addition, they will complete naturalistic end-of-day
assessments of mood, stress, appraisal and coping for 7 days every 2 weeks. If the Go milestone criteria are
met, the R33 phase (years 3-5) will include a 3-arm RCT (Study 2) with 200 new participants randomized in a
2:1:1 ratio to 1 of 3 arms: Lumen (n=100), waitlist control (n=50), and in-person PST as active control (n=50).
Participants will complete baseline and follow-up assessments using a refined measurement protocol based on
Study 1. SPECIFIC AIMS: R61 aims are to (1) establish the functionality, usability, and treatment fidelity of
Lumen; and (2) demonstrate feasibility, acceptability, and neural target engagement according to pre-specified
Go milestone criteria. R33 aims are to (1) confirm neural target engagement by a superiority test (primary)
comparing the Lumen and waitlist control arms and a noninferiority test (secondary) comparing the Lumen and
in-person PST arms; and (2) examine the relationships of target engagement to outcomes. The results will
provide the basis for future confirmatory efficacy testing of Lumen. IMPACT...

## Key facts

- **NIH application ID:** 10886014
- **Project number:** 5R33MH119237-04
- **Recipient organization:** UNIVERSITY OF ILLINOIS AT CHICAGO
- **Principal Investigator:** Olusola A. Ajilore
- **Activity code:** R33 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $920,725
- **Award type:** 5
- **Project period:** 2020-07-03 → 2025-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10886014

## Citation

> US National Institutes of Health, RePORTER application 10886014, Study of a PST-Trained Voice-Enabled Artificial Intelligence Counselor (SPEAC) for Adults with Emotional Distress (5R33MH119237-04). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10886014. Licensed CC0.

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