CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 63 enrolled
Drug / intervention
Lumen Treatmentbehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04524104
NCT04524104N/ACompleted

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

University of Illinois at Chicago·interventional·Posted Aug 24, 2020·Updated Jul 9, 2024

In Brief

A clinical study evaluating Lumen Treatment for Depression and Anxiety. Completed, enrolled 63 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDepression, Anxiety
CountriesUnited States

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedAug 24, 2020
Enrollment StartApr 5, 2021
Primary CompletionFeb 8, 2022
Study CompletionMar 5, 2022
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 5.9 years ago

Interventions

Lumen Treatmentbehavioral

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.