Clinical trial NCT05603923: Study of a PST-Trained Voice-Enabled Artificial Intelligence Counselor(SPEAC) for Adults With Emotional Distress (Phase 2)
Official title: Study of a PST-Trained Voice-Enabled Artificial Intelligence Counselor(SPEAC) for Adults With Emotional Distress (Phase 2)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Anxiety
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
Collaborators: name: Penn State University
name: Washington University School of Medicine
name: Stanford University
name: National Institute of Mental Health (NIMH)
First posted: 2022-11-03
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Approximately 200 Participants with mild-to-moderate, untreated depression and/or anxiety will be randomly assigned (by chance, like flipping a coin) to 1 of 3 study groups: Lumen Coached Problem-Solving Treatment (PST) (n=100), Human Coached PST (n=50), and optional (delayed) Lumen Coached PST as waitlist control (n=50) to improve emotional health. All participants will complete assessments at baseline and at 18 weeks post randomization.

Depending on the group assignment the PST program will be delivered by Lumen, a virtual voice-based coach on a study iPad, or by a human coach in person for the first session and then via videoconference or phone for the remaining 7 sessions. Participants assigned to the waitlist control group can receive the Lumen coached PST on a study iPad after completing their 18-week follow-up assessment.

Participants will receive 8 coaching sessions to learn problem-solving skills and work on unresolved problems in daily living that may be interfering with their emotional well-being and contributing to depression and anxiety symptoms.

Detailed description: All participants will complete measurements of neural target engagement and treatment outcomes at both baseline (0 week) and 18 weeks.

Study Visit 1: This will include (1) Physical measurements such as height, weight, and blood pressure, (2) functional magnetic resonance imaging (fMRI) scan, (3) surveys of intervention-related measures, and (4) surveys of patient-reported outcomes, such as depressive and anxiety symptoms, social functioning, and health-related quality of life.

Following the successful completion of Visit 1 and all the surveys, participants will be randomly assigned (by chance, like flipping a coin) to 1 of 3 study groups, as described below.

Problem Solving Treatment (PST) Groups

Group 1: Lumen Coached Group :

Participants assigned to this group will attend an Intervention Orientation session to receive the Coach Lumen tutorial, a study iPad, and a Lumen Intervention Workbook. They will complete 8 PST sessions (4 weekly and then 4 biweekly) with Coach Lumen at home over 12 weeks.

Group 2: Human Coached Group Participants assigned to this group will receive a study iPad and Human-Coached Intervention Workbook, and will complete 8 PST sessions (4 weekly and then 4 biweekly) with a trained health coach over 12 weeks. They will complete the first session in person and then the remaining sessions via videoconference or phone.

Group 3: Optional (Delayed) Lumen Coached Group Participants assigned to this group may choose to attend a Lumen Orientation session to receive training and a study iPad to complete 8 PST sessions with Coach Lumen after completing their follow-up assessment at 18 weeks.

Regardless of the group assignment, participants will complete brief Nightly Mood Check-in surveys about their thoughts, feelings, and experiences over the day, for 7 nights, approximately every other week over 18 weeks (i.e., a total of 58 nights). These check-ins are sent via text message to their mobile phone.

Study Visit 2:

Regardless of group assignment, participants will be asked to attend a second in-person visit for data collection at 18 weeks. Like Visit 1, Visit 2 will include physical measurements, a brain scan (after a negative pregnancy urine test, if applicable), and online surveys (if not yet completed before the visit), and will last approximately 90 minutes.

Eligibility criteria: 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

Primary outcomes:
measure: Change from Baseline Functional Magnetic Resonance Scan at 18 weeks
timeFrame: Baseline, 18 weeks
Secondary outcomes:
measure: Change from baseline Penn State Worry Questionnaire (PSWQ) at 18 weeks
timeFrame: Baseline, 18 weeks
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Department of Medicine, Vitoux Program on Aging and Prevention
state: Illinois
city: Chicago
country: United States
facility: UIMC Advanced Imaging Center
state: Illinois
Study officials:
affiliation: University of Illinois at Chicago
name: Jun Ma, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: