Study of a PST-Trained Voice-Enabled Artificial Intelligence Counselor (SPEAC) for Adults With Emotional Distress (Phase 1)

University of Illinois

Status: Completed

Conditions: Depression; Anxiety

Treatments: Behavioral: Lumen Treatment

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04524104

1R61MH119237-01A1 (U.S. NIH Grant/Contract)

2020-0918

Details and patient eligibility

About

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.

Full 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 receive encrypted study iPads.

Lumen treatment arm participants will receive encrypted study iPads to complete PST with Lumen (8 sessions, 4 weekly and then 4 biweekly, over 12 weeks) or be on a wait list. Participant permission will be obtained to record their PST sessions with Lumen, which will be independently rated by PST experts for fidelity. Lumen treatment arm participants will also complete the depressive and anxiety symptoms assessment questionnaires at the start of each PST session, and a participant survey of usability, user experience and therapeutic alliance at the end of each PST session.

Participants in both arms will complete measurements of neural target engagement and treatment outcomes at both baseline (0 week) and 16 weeks.

These assessments will include (1) functional magnetic resonance imaging (fMRI) 2) Surveys of PST (3) Surveys of patient-reported outcomes, such as depressive and anxiety symptoms, social functioning, and health-related quality of life. Participants also will complete naturalistic end-of-day assessments of mood, stress, appraisal, and coping for 7 days every 2 weeks (on weeks 0, 2, 4, 6, 8, 10, 12, 16) - that is, 8 time series.

Participants in the wait-list control arm will have the option to receive Lumen at the end of the study. The PST module on the study iPad will be disabled until their 16-week assessment is completed, at which time they will have the option to complete 8 PST sessions on their assigned iPads.

Enrollment: 63 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

63 participants in 2 patient groups

Lumen treatment

Experimental group

Description:

Participants will complete functional magnetic resonance imaging (fMRI) and self-report questionnaires at baseline and 16 weeks. Participant will receive an encrypted study iPad enabled with Lumen at baseline. They will complete 8 PST sessions beginning with 4 weekly and then 4 biweekly intervals (i.e., on weeks 1, 2, 3, 4, 6, 8, 10, 12) over 12 weeks on their assigned iPad. Participants will also complete naturalistic end-of-day assessments for 7 days every 2 weeks (on weeks 0, 2, 4, 6, 8, 10, 12, 16), that is, 8 time series. Additionally, participants will complete depressive and anxiety symptoms questionnaire and user experience surveys at all PST sessions.

Treatment:

Behavioral: Lumen Treatment

Waitlist Control

No Intervention group

Description:

Participants will complete functional magnetic resonance imaging (fMRI) and self-report questionnaires at Baseline and 16 weeks. Participant will receive an encrypted study iPad at baseline. Participants will complete naturalistic end-of-day assessments for 7 days every 2 weeks (on weeks 0, 2, 4, 6, 8, 10, 12, 16), that is, 8 time series. Participants in the waitlist control arm will only complete assessments but will have the option to receive Lumen at the end of the study. The PST module on the study iPad will be disabled until their 16-week assessment is completed, at which time they will have the option to complete 8 PST sessions on their assigned iPads.