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Can an AI voice coach ease depression? new study tests lumen

NCT ID NCT05603923

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether an AI voice coach called Lumen can help adults with mild-to-moderate depression or anxiety. 200 participants were randomly assigned to receive problem-solving training from Lumen, a human coach, or a waitlist. The goal was to see if the AI coach could improve emotional well-being by teaching practical skills to tackle daily problems.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Lumen voice-based AI coach delivering Problem-Solving Treatment (PST)
What this could lead to
If it works, this could offer a convenient, accessible way to help people manage depression and anxiety symptoms without medication or in-person therapy.
What could go wrong
This is a small, early-phase study (200 people) comparing AI coaching to human coaching and a waitlist. Results may not apply to everyone, and the AI may not be as effective as human therapists.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

200 people

The number who actually took part.

Started

Jan 2023

Finished

Apr 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Exclusion Criteria: * 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) * 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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Department of Medicine, Vitoux Program on Aging and Prevention

    Chicago, Illinois, 60608, United States

  • UIMC Advanced Imaging Center

    Chicago, Illinois, 60612, United States

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