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NCT04524104 · ClinicalTrials.gov registry record · NA
Study of a PST-Trained Voice-Enabled Artificial Intelligence Counselor (SPEAC) for Adults With Emotional Distress (Phase 1)
A NA study of Depression and Anxiety, sponsored by University of Illinois at Chicago.
- Completed
- Registry status
- NA
- Development phase
- 63
- Enrollment target
- 2
- Study locations
NCT04524104: Completed NA study of Depression and Anxiety, sponsored by University of Illinois at Chicago.
NCT04524104 is a NA study of Depression and Anxiety that has completed, run by University of Illinois at Chicago. The registered enrollment target is 63 participants, below the 786-participant average among 679 other Depression trials with a reported enrollment target (92% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04524104, a NA study of Depression and Anxiety, has completed, sponsored by University of Illinois at Chicago.
- COMPLETED
- Registry status
- NA
- Development phase
- 63 participants
- Enrollment target
- 2
- Study locations
Study 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.
Primary Outcome
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), sad-related emotions (sadness) and reward-related emotions (happiness), along w
Conditions Studied
Interventions
- BEHAVIORAL Lumen Treatment
Study Locations (2)
Illinois
- Department of Medicine, Vitoux Program on Aging and Prevention - Chicago
- UIMC Advanced Imaging Center - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 63 participants |
| Start Date | 2021-04-05 |
| Est. Completion | 2022-03-05 |
| Phase | NA |
What the finished NCT04524104 record still lists
NCT04524104 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 63 participants, a relatively small participant target, below the 786-participant average among 679 other Depression trials with a reported enrollment target (92% lower).
The record links to 2 conditions, with Depression appearing as the primary indexed condition, and to 1 intervention - of which Lumen Treatment is the first listed.
NCT04524104 reports a single indexed study location in Illinois.
Frequently Asked Questions
What is clinical trial NCT04524104 about?
NCT04524104 is a clinical study titled "Study of a PST-Trained Voice-Enabled Artificial Intelligence Counselor (SPEAC) for Adults With Emotional Distress (Phase 1)". 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 pil...
What is the current status of trial NCT04524104?
This trial is currently completed. It is a NA study. The enrollment target is 63 participants. The study started on 2021-04-05. Estimated completion is 2022-03-05.
What conditions does trial NCT04524104 study?
This clinical trial studies the following conditions: Depression, Anxiety.
What interventions are being tested in trial NCT04524104?
The interventions under investigation include: Lumen Treatment (BEHAVIORAL).
Who is sponsoring clinical trial NCT04524104?
This trial is sponsored by University of Illinois at Chicago, which has 430 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04524104 being conducted?
This trial has 2 study locations across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04524104's enrollment target sits among peer trials
63 426th of 679 higher than 253 of 679 other Depression trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Depression trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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