Study of a PST-Trained Voice-Enabled Artificial Intelligence Counselor(SPEAC) for Adults With Emotional Distress (Phase 2)

NCT05603923 | Completed

• 2 other identifiers: 2022-1052R33MH119237
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

Brief Summary

Approximately 200 Participants with mild-to-moderate, untreated depression and/or anxiety will be randomly assigned (by chance, like flipping a coin) to 1 of 3 study groups: Lumen Coached Problem-Solving Treatment (PST) (n=100), Human Coached PST (n=50), and optional (delayed) Lumen Coached PST as waitlist control (n=50) to improve emotional health. All participants will complete assessments at baseline and at 18 weeks post randomization. Depending on the group assignment the PST program will be delivered by Lumen, a virtual voice-based coach on a study iPad, or by a human coach in person for the first session and then via videoconference or phone for the remaining 7 sessions. Participants assigned to the waitlist control group can receive the Lumen coached PST on a study iPad after completing their 18-week follow-up assessment. Participants will receive 8 coaching sessions to learn problem-solving skills and work on unresolved problems in daily living that may be interfering with their emotional well-being and contributing to depression and anxiety symptoms.

Conditions

Depression; Anxiety

Outcome Measures

Primary Outcomes (1)

• Change from Baseline Functional Magnetic Resonance Scan at 18 weeks

  Outcome Description 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. The right DLPFC is the primary neural target, while the left DLPFC and bilateral amygdala are secondary neural targets. 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), loss-related emotions (sadness) and reward-related emotions (happiness), along with neutral. For the Go-NoGo paradigm, the 'Go' and 'NoGo' stimuli are presented for 500 ms each with an inter-stimulus interval of 750 ms. The 2 paradigms are empirically validated probes of emotional reactivity and cognitive control, respectively.

  Baseline, 18 weeks

Secondary Outcomes (10)

• Change from Baseline Hospital Anxiety and Depression Scale (HADS) at 18 weeks

  Baseline, 18 weeks

• Change from Baseline Penn State Worry Questionnaire (PSWQ) at 18 weeks

  Baseline, 18 weeks

• Change from Baseline Positive and Negative Affect Schedule (PANAS) at 18 weeks

  Baseline, 18 weeks

• Change from Baseline Social Problem-Solving Inventory-Revised: Short Form (SPSI-R:S) at 18 weeks

  Baseline, 18 weeks

• Change from Baseline Dysfunctional Attitudes Scale (DAS) at 18 weeks

  Baseline, 18 weeks

Other Outcomes (4)

• Patient Health Questionnaire (PHQ-9)

  Before all PST sessions (in weeks 1, 2, 3, 4, 6, 8, 10, 12)

• Generalized Anxiety Disorder Scale (GAD-7)

  Before all PST sessions (in weeks 1, 2, 3, 4, 6, 8, 10, 12)

• User Experience Questionnaire-Short version (UEQ-S)

  After Lumen Session 1, Session 4, Session 8

Study Arms (3)

Group 1: Lumen Coached Group

ACTIVE COMPARATOR

Participants in this group will attend an Intervention Orientation session to receive the Coach Lumen tutorial, a study iPad, and a Lumen Intervention Workbook. They will complete 8 PST sessions with Coach Lumen using their study assigned iPad at home over 12 weeks. The first 4 sessions occur weekly and then the last 4 occur every other week. Participants will receive automated reminders on the day before and on the day of their scheduled session, and have the opportunity to reschedule sessions through the iPad. Participants will work with Coach Lumen to learn problem-solving skills to address current life challenges, plan activities, and complete home activities. Participants will also complete surveys before and after each PST session: a mood assessment survey before and a user experience survey after. At the end of study, Participants may be invited to provide their perspective regarding their Lumen use experience.

Behavioral: Lumen Coached PST Intervention.

Group 2: Human Coached Group

ACTIVE COMPARATOR

Participants in this group will receive a study iPad and Human-Coached Intervention Workbook and will complete the first of 8 PST sessions in person with a trained health coach. Participants' first PST session will be in person for approximately 1 hour. Participants will complete the remaining sessions remotely via Zoom (or by phone, if necessary) using their study iPad. The first 4 sessions occur weekly and then the last 4 occur every other week. Participants will receive automated reminder notifications on the day before and on the day of their scheduled session, and have the opportunity to reschedule sessions with their coach. Participants will also complete a mood assessment survey at the beginning of each PST session. Participants will work with their health coach to learn problem-solving skills to address current life challenges, plan activities, and complete home activities.

Behavioral: Human Coached PST Intervention.

Group 3: Optional (Delayed) Lumen Coached Group

PLACEBO COMPARATOR

Participants assigned to this group can choose to attend a Lumen Orientation session to receive training and a study iPad to complete 8 PST sessions with Coach Lumen after their follow-up assessment at 18 weeks. They will receive 8 Sunday mood assessment surveys to complete (4 every Sunday and then 4 every other Sunday).

Behavioral: Optional (delayed) Lumen Coached PST (Waitlist control).

Interventions

Lumen Coached PST Intervention. BEHAVIORAL

Lumen Intervention Orientation. Participants in the Lumen intervention arm attend a Lumen orientation visit (60 minutes) during which they will be given a Lumen intervention tutorial and receive a study iPad, configured to limit access to only the Lumen intervention enabled on the device. Before leaving, participants are scheduled for the first PST session with Coach Lumen. At the end of each PST session, participants are prompted to schedule their next session with Coach Lumen. They receive automated reminder notifications 1 day prior to their next session, on the session day, and have the opportunity to make up missed sessions. As needed, Lumen intervention orientations can be done remotely.

Group 1: Lumen Coached Group

Human Coached PST Intervention. BEHAVIORAL

Participants in the human coached PST arm will serve as active treatment controls given the demonstrated efficacy of human coached PST in depression and anxiety. They will complete 8 PST sessions with a human coach; first session in-person and remaining sessions via videoconferencing (i.e., Zoom preferred; with phone calls allowed) on the same 4 weekly and then 4 biweekly schedule as that for Lumen participants. Participants will receive a study iPad to use for their PST sessions via zoom. Participants also complete the PHQ-9 and GAD-7 during each session. Participants will receive a certificate of completion.

Group 2: Human Coached Group

Optional (delayed) Lumen Coached PST (Waitlist control). BEHAVIORAL

Waitlist control participants will only complete assessments during the 18-week trial period. At the end of their 18-week assessment, they will have the option to complete 8 PST sessions on their assigned iPads.

Group 3: Optional (Delayed) Lumen Coached Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: ≥ 18 years
• Emotional distress defined by elevated depressive (PHQ-9 scores 10-19) and/or anxious symptoms (GAD-7 scores 10-14)
• Willing and able to provide informed eConsent and HIPAA authorization

You may not qualify if:

• Unable to speak, read, or understand English for informed consent
• Current pharmacotherapy or psychotherapy (individual or professionally led group therapy) for depression or anxiety (note: participants are not withdrawn post-randomization if they begin pharmacotherapy drugs or start psychotherapy during the study.)
• Suicidal ideation per PHQ-9 with active plan
• Bipolar or psychotic disorder, or current psychiatric treatment
• Weight ≥325 pounds due to brain scanner constraints, MRI contraindications, traumatic brain injuries, and tumor or any other known structural abnormality in the brain
• Severe medical condition (e.g., myocardial infarction or stroke or new cancer diagnosis in the past 6 months, end-stage organ failure, terminal illness) or residence in a long-term care facility
• Diagnosis of cancer (other than non-melanoma skin cancer) that is/was active or treated with radiation or chemotherapy within the past year
• Active alcohol or substance use disorder (including prescription drugs) based on the CAGE Questionnaire Adapted to Include Drugs (CAGE-AID)
• Cognitive impairment based on the Callahan 6-item screener
• Current or planned pregnancy or lactating (\<6 months postpartum)
• Family/household member of an already enrolled participant or of a study team member
• Plan to move out of the Chicago area during the study period
• Does not have reliable Wi-Fi Internet at home
• Unwillingness to user personal mobile device to receive study text messages
• Investigator discretion for clinical safety or protocol adherence reasons

Sponsors & Collaborators

• University of Illinois at Chicago: lead
• Penn State University: collaborator
• Washington University School of Medicine: collaborator
• Stanford University: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (2)

Department of Medicine, Vitoux Program on Aging and Prevention

Chicago, Illinois, 60608, United States

Location

UIMC Advanced Imaging Center

Chicago, Illinois, 60612, United States

Location

Related Publications (2)

• Kannampallil T, Ajilore OA, Smyth JM, Barve A, Ronneberg CR, Lv N, Kumar V, Garcia C, Aborisade G, Wittels NE, Tang Z, Chinnakotla B, Xiao L, Ma J. Effect and Mechanisms of a Voice-based Coach using AI on Psychological Distress: A Phase 2 Randomized Trial. medRxiv [Preprint]. 2025 Dec 29:2025.12.22.25342792. doi: 10.64898/2025.12.22.25342792.

  PMID: 41503467 DERIVED

• Ronneberg CR, Lv N, Ajilore OA, Kannampallil T, Smyth J, Kumar V, Barve A, Garcia C, Dosala S, Wittels N, Xiao L, Aborisade G, Zhang A, Tang Z, Johnson J, Ma J. Study of a PST-trained voice-enabled artificial intelligence counselor for adults with emotional distress (SPEAC-2): Design and methods. Contemp Clin Trials. 2024 Jul;142:107574. doi: 10.1016/j.cct.2024.107574. Epub 2024 May 18.

  PMID: 38763307 DERIVED

MeSH Terms

Conditions

Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Jun Ma, MD, PhD

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Principal Investigator, Beth and George Vitoux Professor of Medicine

Study Record Dates

• First Submitted: October 28, 2022
• First Posted: November 3, 2022
• Study Start: January 23, 2023
• Primary Completion: April 15, 2025
• Study Completion: April 15, 2025
• Last Updated: January 21, 2026

Record last verified: 2026-01

Locations

US (2)