Study of a PST-Trained Voice-Enabled Artificial Intelligence Counselor (SPEAC) for Adults With Emotional Distress (Phase 1)
Trial ID: NCT04524104
Status: COMPLETED
Study type: INTERVENTIONAL
Phase: NA
Start date: 2021-04-05
Completion date: 2022-03-05
Sponsor: University of Illinois at Chicago
Collaborators: Penn State University; Washington University School of Medicine; Stanford University; National Institute of Mental Health (NIMH)
Conditions: Depression; Anxiety
Interventions: Lumen Treatment
Locations: Department of Medicine, Vitoux Program on Aging and Prevention; UIMC Advanced Imaging Center
Countries: United States; United States
Enrollment: 63
Age range: 18 Years - None
Sex: ALL

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 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.

Eligibility criteria:
Inclusion Criteria:

* 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 Criteria:

* 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

Outcomes:
Change in Activation of Left Amygdala From Baseline Functional Magnetic Resonance Scan at 16 Weeks; Change in Activation of Right Amygdala From Baseline Functional Magnetic Resonance Scan at 16 Weeks; Change in Activation of Left dlPFC From Baseline Functional Magnetic Resonance Scan at 16 Weeks; Change in Activation of Right dlPFC From Baseline Functional Magnetic Resonance Scan at 16 Weeks