Study of a PST-Trained Voice-Enabled Artificial Intelligence Counselor (SPEAC) for Adults With Emotional Distress (Phase 1)
Completed · Not applicable
Conditions studied: Depression, Anxiety
In brief
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.
Key facts
- Study ID
- NCT04524104
- Run by
- University of Illinois at Chicago
- People needed
- 63
- Starts
- 2021-04-05
- Expected to finish
- 2022-03-05
- Last updated by the study team
- 2024-07-09
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 18 years of age or older at study enrollment
- Emotional distress defined by elevated depressive (PHQ9 scores 10-19) and/or anxious symptoms (GAD7 scores 10-14)
- Willing and able to provide written informed consent and HIPAA authorization
You may not qualify if…
- Unable to speak, read, understand English for informed consent (grade 6 level)
- Current pharmacotherapy or psychotherapy (individual or professionally-led group therapy) for depression or anxiety
- Suicidal ideation per PHQ9 with active plan
- Bipolar or psychotic disorder, or current psychiatric treatment
- Weight ≥350 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 Chicagoland area during the study period
- Investigator discretion for clinical safety or protocol adherence reasons
Where it is running
- Department of Medicine, Vitoux Program on Aging and Prevention — Chicago, Illinois, United States
- UIMC Advanced Imaging Center — Chicago, Illinois, United States
Full record on ClinicalTrials.gov
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