Clinical trial NCT04524104: Study of a PST-Trained Voice-Enabled Artificial Intelligence Counselor (SPEAC) for Adults With Emotional Distress (Phase 1)
Official title: Study of a PST-Trained Voice-Enabled Artificial Intelligence Counselor (SPEAC) for Adults With Emotional Distress (Phase 1)
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: 2020-08-24
Enrollment: 63
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: 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.

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 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.

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

Primary outcomes:
measure: Change in Activation of Left Amygdala From Baseline Functional Magnetic Resonance Scan at 16 Weeks
timeFrame: Baseline, 16 weeks
measure: Change in Activation of Right Amygdala From Baseline Functional Magnetic Resonance Scan at 16 Weeks
timeFrame: Baseline, 16 weeks
measure: Change in Activation of Left dlPFC From Baseline Functional Magnetic Resonance Scan at 16 Weeks
timeFrame: Baseline, 16 weeks
measure: Change in Activation of Right dlPFC From Baseline Functional Magnetic Resonance Scan at 16 Weeks
timeFrame: Baseline, 16 weeks
Secondary outcomes:
measure: Change From Baseline Hospital Anxiety and Depression Scale (HADS) Depression Score at 16 Weeks
timeFrame: Baseline, 16 weeks
measure: Change From Baseline Hospital Anxiety and Depression Scale (HADS) Anxiety Score at 16 Weeks
timeFrame: Baseline, 16 weeks
measure: Change From Baseline Hospital Anxiety and Depression Scale (HADS) Total Score at 16 Weeks
timeFrame: Baseline, 16 weeks
measure: Change From Baseline Social Problem-Solving Inventory-Revised: Short Form (SPSI-R:S) at 16 Weeks
timeFrame: Baseline, 16 weeks
measure: Change From Baseline Dysfunctional Attitudes Scale (DAS) at 16 Weeks
timeFrame: Baseline, 16 weeks
measure: Change From Baseline Penn State Worry Questionnaire (PSWQ) at 16 Weeks
timeFrame: Baseline, 16 weeks
measure: Change From Baseline Positive Affect Score of the Positive and Negative Affect Schedule (PANAS) at 16 Weeks
timeFrame: Baseline, 16 weeks
measure: Change From Baseline Negative Affect Score of the Positive and Negative Affect Schedule (PANAS) at 16 Weeks
timeFrame: Baseline, 16 weeks
measure: Change From Baseline Sheehan Disability Scale at 16 Weeks
timeFrame: Baseline, 16 weeks
measure: Change From Baseline Percent Work Time Missed Due to Health at 16 Weeks
timeFrame: Baseline, 16 weeks
measure: Change From Baseline Percent Impairment While Working Due to Health at 16 Weeks
timeFrame: Baseline, 16 weeks
measure: Change From Baseline Percent Overall Work Impairment Due to Health at 16 Weeks
timeFrame: Baseline, 16 weeks
measure: Change From Baseline Percent Activity Impairment Due to Health at 16 Weeks
timeFrame: Baseline, 16 weeks
measure: Change From Baseline Physical Health Composite Score of the 12-item Short-Form Health Survey (SF12) at 16 Weeks
timeFrame: Baseline, 16 weeks
measure: Change From Baseline Mental Health Composite Score of the 12-item Short-Form Health Survey (SF12) at 16 Weeks
timeFrame: Baseline, 16 weeks
measure: Change From Baseline Daily Mood (Positive Affect) at 16 Weeks
timeFrame: From Baseline to every 2 week, up to 16 weeks
measure: Change From Baseline Daily Mood (Negative Affect) at 16 Weeks
timeFrame: From Baseline to every 2 week, up to 16 weeks
measure: Change From Baseline Daily Stress at 16 Weeks
timeFrame: From Baseline to every 2 weeks, up to 16 weeks
measure: Change From Baseline Daily Appraisal at 16 Weeks
timeFrame: From Baseline to every 2 weeks, up to 16 weeks
measure: Change in Depression Symptoms From First PST Session in Week 1 to Eighth Session in 12 Weeks
timeFrame: From start of first PST session in week 1 to week (2, 3, 4, 6, 8, 10, 12) up to 12 weeks
measure: Change in Anxiety Symptoms From First PST Session in Week 1 to Eighth Session in 12 Weeks
timeFrame: From start of first PST session in week 1 to week (2, 3, 4, 6, 8, 10, 12) up to 12 weeks
measure: Change in NASA Task Load Index (TLX) From First PST Session in Week 1 to Eighth Session in 12 Weeks
timeFrame: From end of first PST session in week 1 to week (in week, 2, 3, 4, 6, 8, 10, 12) up to 12 weeks
measure: Change in User Experience Questionnaire-Short Version (UEQ-S) From First PST Session in Week 1 to Eighth Session in 12 Weeks
timeFrame: From end first PST session in week 1 to week (in week 2, 3, 4, 6, 8, 10, 12) up to 12 weeks
measure: Change in Adapted Working Alliance Inventory for Digital Coaching Interventions (WAI-Tech) From First PST Session in Week 1 to Eighth Session in 12 Weeks
timeFrame: From end of first PST session in week 1 to week (in week 2, 3, 4, 6, 8, 10, 12) up to 12 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: