Status:
COMPLETED
Study of a PST-Trained Voice-Enabled Artificial Intelligence Counselor (SPEAC) for Adults With Emotional Distress (Phase 1)
Lead Sponsor:
University of Illinois at Chicago
Collaborating Sponsors:
Penn State University
Washington University School of Medicine
Conditions:
Depression
Anxiety
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 format...
Detailed Description
60 participants with eligible depression and/or anxiety (n=60) will be randomized in a 2:1 ratio to the Lumen treatment arm (n=40) or the wait-list control arm (n=20). Participants in both arms will ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
April 5 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 5 2022
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT04524104
Start Date
April 5 2021
End Date
March 5 2022
Last Update
July 9 2024
Active Locations (2)
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1
Department of Medicine, Vitoux Program on Aging and Prevention
Chicago, Illinois, United States, 60608
2
UIMC Advanced Imaging Center
Chicago, Illinois, United States, 60612