DepressionSPEACNCT05603923
Study of a PST-Trained Voice-Enabled Artificial Intelligence Counselor(SPEAC) for Adults With Emotional Distress (Phase 2)
A study testing Lumen Coached PST Intervention. and Human Coached PST Intervention. in people with Depression and Anxiety, run by University of Illinois Chicago at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression, Anxiety
- What is being tested?
- Lumen Coached PST Intervention. and Human Coached PST Intervention.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 2 sitesUnited States
- Study dates
- 23 Jan 2023to 15 Apr 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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or psychotherapy (individual or professionally led group therapy) for depression or anxiety (note: participants are not withdrawn post-randomization if they begin pharmacotherapy drugs or start psychotherapy during the study.)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
Show all 16Show fewer
- 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)
- Participation in other investigational treatment studies that would significantly affect participation in this study, raise safety concerns, and/or confound outcomes (participant may be asked to provide the informed consent of the other study for final decision on exclusion by a study psychiatrist)
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Department of Medicine, Vitoux Program on Aging and Prevention
Chicago, Illinois, 60608
UIMC Advanced Imaging Center
Chicago, Illinois, 60612
About this study
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.
Read the detailed description
All participants will complete measurements of neural target engagement and treatment outcomes at both baseline (0 week) and 18 weeks.
Study Visit 1: This will include (1) Physical measurements such as height, weight, and blood pressure, (2) functional magnetic resonance imaging (fMRI) scan, (3) surveys of intervention-related measures, and (4) surveys of patient-reported outcomes, such as depressive and anxiety symptoms, social functioning, and health-related quality of life.
Following the successful completion of Visit 1 and all the surveys, participants will be randomly assigned (by chance, like flipping a coin) to 1 of 3 study groups, as described below.
Problem Solving Treatment (PST) Groups
Group 1: Lumen Coached Group :
Participants assigned to 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 (4 weekly and then 4 biweekly) with Coach Lumen at home over 12 weeks.
Group 2: Human Coached Group Participants assigned to this group will receive a study iPad and Human-Coached Intervention Workbook, and will complete 8 PST sessions (4 weekly and then 4 biweekly) with a trained health coach over 12 weeks. They will complete the first session in person and then the remaining sessions via videoconference or phone.
Group 3: Optional (Delayed) Lumen Coached Group Participants assigned to this group may choose to attend a Lumen Orientation session to receive training and a study iPad to complete 8 PST sessions with Coach Lumen after completing their follow-up assessment at 18 weeks.
Regardless of the group assignment, participants will complete brief Nightly Mood Check-in surveys about their thoughts, feelings, and experiences over the day, for 7 nights, approximately every other week over 18 weeks (i.e., a total of 58 nights). These check-ins are sent via text message to their mobile phone.
Study Visit 2:
Regardless of group assignment, participants will be asked to attend a second in-person visit for data collection at 18 weeks. Like Visit 1, Visit 2 will include physical measurements, a brain scan (after a negative pregnancy urine test, if applicable), and online surveys (if not yet completed before the visit), and will last approximately 90 minutes.
- Conditions
- Depression, Anxiety
- Being tested
- Lumen Coached PST Intervention., Human Coached PST Intervention., Optional (delayed) Lumen Coached PST (Waitlist control).
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumen Coached PST Intervention.Behavioural
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.
Human Coached PST Intervention.Behavioural
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.
Optional (delayed) Lumen Coached PST (Waitlist control).Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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). Receives: Behavioral: Optional (delayed) Lumen Coached PST (Waitlist control). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline Functional Magnetic Resonance Scan at 18 Weeks
Two neural targets defined a priori, specifically activation of the amygdala for nonconscious threat-related emotional reactivity and activation of the dorsal lateral prefrontal cortex (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 beta weight is a standardized regression coefficient. Positive beta weights mean greater activation, and Negative beta weights mean less activation in the specific brain region being monitored.
Measured: Baseline, 18 weeks
Secondary outcomes (10)
Change From Baseline Hospital Anxiety and Depression Scale (HADS) at 18 Weeks
HADS, including 7 questions for anxiety and 7 questions for depression, measures self-reported anxiety and depression in a general medical population of patients. Each item on the questionnaire is scored from 0-3 and the score for either anxiety or depression ranges between 0 and 21 with the following categories: normal 0-7, mild 8-10, moderate 11-14, and severe 15-21. Total score for the entire scale (psychological distress) ranges from 0 to 42, with higher score indicating more distress.
Measured: Baseline, 18 weeks
Change From Baseline Penn State Worry Questionnaire (PSWQ) at 18 Weeks
Penn State Worry Questionnaire (PSWQ) is a self-reported, 16-item, Likert-type scale that measures the trait of worry. Each item is related on a 1-5 scale. The total score of the scale ranges from 16 to 80, with higher scores indicating higher trait worry.
Measured: Baseline, 18 weeks
Change From Baseline Positive and Negative Affect Schedule (PANAS) at 18 Weeks
Positive and Negative Affect Schedule (PANAS) consists of two 10-item self-reported scales to measure positive and negative affect. Each item asks about the extent one has felt a positive or negative feeling on a 5-point scale of 1 (not at all) to 5 (very much). Positive Affect scores can range from 10 - 50, with higher scores representing higher levels of positive affect. Negative affect scores can range from 10 - 50, with lower scores representing lower levels of negative affect.
Measured: Baseline, 18 weeks
Change From Baseline Social Problem-Solving Inventory-Revised: Short Form (SPSI-R:S) at 18 Weeks
Participants' problem solving abilities will be assessed using the Social Problem-Solving Inventory-Revised: Short Form (SPSI-R:S) that contains 25 items in the following 5 subscales: positive problem orientation (PPO), negative problem orientation (NPO), rational problem solving (RPS), impulsive/careless style (ICS), and avoidance style (AS). Each item is rated on a 5-point scale ranging from "not at all true of me" (0) to "extremely true of me" (4). The total problem-solving ability score=(PPO raw score/5)+(20- NPO raw score)/5+ (RPS raw score/5)+(20- ICS raw score)/5+(20- AS raw score)/5. It ranged from 0 to 20, with the higher score indicating more productive problem-solving skills. Subscales scores (PPO, NPO, RPS, ICS, and AS) are raw scores without reversal. They range from 0 to 20, with the higher scores indicating the more positive and negative orientation, and the more rational, impulsive/careless, and avoidance style, respectively.
Measured: Baseline, 18 weeks
Change From Baseline Dysfunctional Attitudes Scale (DAS) at 18 Weeks
Dysfunctional Attitudes Scale (DAS Form A) is a 40-item self-reported scale that measures the presence and intensity of dysfunctional attitudes. Each item is rated a 7-point Likert scale (7 = fully agree; 1 = fully disagree) for a total scale range of 40 to 280. The higher the sum of the 40-items, the more dysfunctional attitudes an individual possesses.
Measured: Baseline, 18 weeks
Change From Baseline Sheehan Disability Total Score at 18 Weeks
The Sheehan Disability Scale is a validated questionnaire that measures functional disability and is sensitive to treatment effects in clinical trials. Patients rate the extent to which their symptoms impair work/school, social, and family life on a visual analog scale from 0 to 10. Total score is the sum of the three separate scores on work/school, social, and family life. Total scores range 0-30, with higher scores indicating greater functional impairment.
Measured: Baseline, 18 weeks
Change From Baseline Work Productivity and Activity Impairment Questionnaire (WPAI) at 18 Weeks
The Work Productivity and Activity Impairment questionnaire (WPAI) consists of 6 questions: 1 = currently employed; 2 = hours missed due to health problems; 3 = hours missed other reasons; 4 = hours actually worked; 5 = degree health affected productivity while working (using a 0 to 10 Visual Analogue Scale (VAS)); 6 = degree health affected productivity in regular unpaid activities (VAS). The recall period for the questions 2 to 6 is 7 days. Four main outcomes can be generated from the WPAI-GH and expressed in percentages by multiplying the following scores by 100: 1) percent work time missed due to health = Q2/(Q2 + Q4) for those who were currently employed; 2) percent impairment while working due to health = Q5/10 for those who were currently employed and actually worked in the past 7 days; 3) percent overall work impairment due to health Q2/(Q2 + Q4) + ((1 - Q2/(Q2 + Q4)) × (Q5/10)) for those who were currently employed; 4) percent activity impairment due to health Q6/10 for all.
Measured: Baseline, 18 weeks
Change From Baseline Daily Mood (Positive Affect and Negative Affect) at 18 Weeks
Daily end-of-day assessments will be captured over a one-week period at baseline and every 2 weeks (i.e., on weeks 2, 4, 6, 8, 10, 12, and 18). Changes in weekly average from baseline to week 18 are reported below. During active treatment in the Lumen arm and the in-person PST arm, this will occur for 3 days prior to, the day of, and for 3 days after a scheduled PST session. For waitlist controls, this will occur for 7 days starting on Sunday of each assigned week. Daily mood will be measured using 8 mood items (0 = Not at all, 6 = Extremely), with 4 measuring positive affect and 4 measuring negative affect. Positive affect score is mean of item scores, with higher scores indicating more positive affect. Negative affect score is mean of item scores, with higher scores indicating more negative affect.
Measured: Baseline and every 2 weeks (i.e., on weeks 2, 4, 6, 8, 10, 12, and 18)
Change From Baseline Daily Stress at 18 Weeks
Daily end-of-day assessments will be captured over a one-week period at baseline and every 2 weeks (i.e., on weeks 2, 4, 6, 8, 10, 12, and 18). Changes in weekly average from baseline to week 18 are reported below. During active treatment in the Lumen arm and the in-person PST arm, this will occur for 3 days prior to, the day of, and for 3 days after a scheduled PST session. For waitlist controls, this will occur for 7 days starting on Sunday of each assigned week. Daily stress will be assessed by the question "how stressful was your day today" (0 = Not at all, 6 = Extremely).
Measured: Baseline and every 2 weeks (i.e., on weeks 2, 4, 6, 8, 10, 12, and 18)
Change From Baseline Daily Appraisal at 18 Weeks
Daily end-of-day assessments will be captured over a one-week period at baseline and every 2 weeks (i.e., on weeks 2, 4, 6, 8, 10, 12, and 18). Changes in weekly average from baseline to week 18 are reported below. During active treatment in the Lumen arm and the in-person PST arm, this will occur for 3 days prior to, the day of, and for 3 days after a scheduled PST session. For waitlist controls, this will occur for 7 days starting on Sunday of each assigned week. The appraisal question asks "To what degree were you able to accept your problem as normal or an expected part of everyday life?" (0 = Not at all, 6 = A great deal), which a higher score indicating a greater degree of ability to accept problem as normal or expected.
Measured: Baseline and every 2 weeks (i.e., on weeks 2, 4, 6, 8, 10, 12, and 18)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2022
- Study start23 Jan 2023
- Primary completion15 Apr 2025
- Study completion15 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Penn State University, Washington University School of Medicine, Stanford University, National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Jun Ma, University of Illinois Chicago
- Investigators
- Jun Ma, MD, PhD, Principal investigator, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05603923
- Sponsor's protocol ID
- 2022-1052
- Other IDs
- R33MH119237
- Acronym
- SPEAC
- Status last verified
- Aug 2026
- First submitted
- 28 Oct 2022
- Last updated
- 23 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 41503467Ronneberg 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.
PubMed 38763307
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of a PST-Trained Voice-Enabled Artificial Intelligence Counselor(SPEAC) for Adults With Emotional Distress (Phase 2)
- ClinicalTrials.gov ID
- NCT05603923
- Acronym / sponsor ID
- SPEAC / 2022-1052
- Conditions
- Depression, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Collaborators
- Penn State University, Washington University School of Medicine, Stanford University, National Institute of Mental Health (NIMH)
- Study start
- 23 Jan 2023 (actual)
- Primary completion
- 15 Apr 2025 (actual)
- Study completion
- 15 Apr 2025 (actual)
- First posted
- 3 Nov 2022 (actual)
- Results
- Posted 23 Sep 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
All participants will complete measurements of neural target engagement and treatment outcomes at both baseline (0 week) and 18 weeks.
Study Visit 1: This will include (1) Physical measurements such as height, weight, and blood pressure, (2) functional magnetic resonance imaging (fMRI) scan, (3) surveys of intervention-related measures, and (4) surveys of patient-reported outcomes, such as depressive and anxiety symptoms, social functioning, and health-related quality of life.
Following the successful completion of Visit 1 and all the surveys, participants will be randomly assigned (by chance, like flipping a coin) to 1 of 3 study groups, as described below.
Problem Solving Treatment (PST) Groups
Group 1: Lumen Coached Group :
Participants assigned to 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 (4 weekly and then 4 biweekly) with Coach Lumen at home over 12 weeks.
Group 2: Human Coached Group Participants assigned to this group will receive a study iPad and Human-Coached Intervention Workbook, and will complete 8 PST sessions (4 weekly and then 4 biweekly) with a trained health coach over 12 weeks. They will complete the first session in person and then the remaining sessions via videoconference or phone.
Group 3: Optional (Delayed) Lumen Coached Group Participants assigned to this group may choose to attend a Lumen Orientation session to receive training and a study iPad to complete 8 PST sessions with Coach Lumen after completing their follow-up assessment at 18 weeks.
Regardless of the group assignment, participants will complete brief Nightly Mood Check-in surveys about their thoughts, feelings, and experiences over the day, for 7 nights, approximately every other week over 18 weeks (i.e., a total of 58 nights). These check-ins are sent via text message to their mobile phone.
Study Visit 2:
Regardless of group assignment, participants will be asked to attend a second in-person visit for data collection at 18 weeks. Like Visit 1, Visit 2 will include physical measurements, a brain scan (after a negative pregnancy urine test, if applicable), and online surveys (if not yet completed before the visit), and will last approximately 90 minutes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1: Lumen Coached Group | Active comparator | Behavioral: Lumen Coached PST Intervention.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. |
| Group 2: Human Coached Group | Active comparator | Behavioral: Human Coached PST Intervention.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. |
| Group 3: Optional (Delayed) Lumen Coached Group | Placebo comparator | Behavioral: Optional (delayed) Lumen Coached PST (Waitlist control).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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lumen Coached PST Intervention.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. | Behavioural | Group 1: Lumen Coached Group |
| Human Coached PST Intervention.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. | Behavioural | Group 2: Human Coached Group |
| Optional (delayed) Lumen Coached PST (Waitlist control).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. | Behavioural | Group 3: Optional (Delayed) Lumen Coached Group |
Primary outcome
Change From Baseline Functional Magnetic Resonance Scan at 18 Weeks
Time frame: Baseline, 18 weeks
Two neural targets defined a priori, specifically activation of the amygdala for nonconscious threat-related emotional reactivity and activation of the dorsal lateral prefrontal cortex (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 beta weight is a standardized regression coefficient. Positive beta weights mean greater activation, and Negative beta weights mean less activation in the specific brain region being monitored.
10 secondary outcomes
Change From Baseline Hospital Anxiety and Depression Scale (HADS) at 18 Weeks
Time frame: Baseline, 18 weeks
Change From Baseline Penn State Worry Questionnaire (PSWQ) at 18 Weeks
Time frame: Baseline, 18 weeks
Change From Baseline Positive and Negative Affect Schedule (PANAS) at 18 Weeks
Time frame: Baseline, 18 weeks
Change From Baseline Social Problem-Solving Inventory-Revised: Short Form (SPSI-R:S) at 18 Weeks
Time frame: Baseline, 18 weeks
Change From Baseline Dysfunctional Attitudes Scale (DAS) at 18 Weeks
Time frame: Baseline, 18 weeks
Change From Baseline Sheehan Disability Total Score at 18 Weeks
Time frame: Baseline, 18 weeks
Change From Baseline Work Productivity and Activity Impairment Questionnaire (WPAI) at 18 Weeks
Time frame: Baseline, 18 weeks
Change From Baseline Daily Mood (Positive Affect and Negative Affect) at 18 Weeks
Time frame: Baseline and every 2 weeks (i.e., on weeks 2, 4, 6, 8, 10, 12, and 18)
Change From Baseline Daily Stress at 18 Weeks
Time frame: Baseline and every 2 weeks (i.e., on weeks 2, 4, 6, 8, 10, 12, and 18)
Change From Baseline Daily Appraisal at 18 Weeks
Time frame: Baseline and every 2 weeks (i.e., on weeks 2, 4, 6, 8, 10, 12, and 18)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41503467Kannampallil 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.
- Derived from this study: PubMed 38763307Ronneberg 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jun Ma, MD, PhD principal investigator
University of Illinois Chicago
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lumen Coached PST Intervention. and Human Coached PST Intervention. in people with Depression and Anxiety, run by University of Illinois Chicago at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline Functional Magnetic Resonance Scan at 18 Weeks (time frame: Baseline, 18 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05603923, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.