Study of a PST-Trained Voice-Enabled Artificial Intelligence Counselor(SPEAC) for Adults With Emotional Distress (Phase 2)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Change From Baseline Functional Magnetic Resonance Scan at 18 Weeks
研究概览
简要总结
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.
详细描述
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 :
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Group 1: Lumen Coached Group
Participants in 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 with Coach Lumen using their study assigned iPad at home over 12 weeks. The first 4 sessions occur weekly and then the last 4 occur every other week. Participants will receive automated reminders on the day before and on the day of their scheduled session, and have the opportunity to reschedule sessions through the iPad. Participants will work with Coach Lumen to learn problem-solving skills to address current life challenges, plan activities, and complete home activities. Participants will also complete surveys before and after each PST session: a mood assessment survey before and a user experience survey after. At the end of study, Participants may be invited to provide their perspective regarding their Lumen use experience.
干预措施: Lumen Coached PST Intervention. (Behavioral)
Group 2: Human Coached Group
Participants in this group will receive a study iPad and Human-Coached Intervention Workbook and will complete the first of 8 PST sessions in person with a trained health coach. Participants' first PST session will be in person for approximately 1 hour. Participants will complete the remaining sessions remotely via Zoom (or by phone, if necessary) using their study iPad. The first 4 sessions occur weekly and then the last 4 occur every other week. Participants will receive automated reminder notifications on the day before and on the day of their scheduled session, and have the opportunity to reschedule sessions with their coach. Participants will also complete a mood assessment survey at the beginning of each PST session. Participants will work with their health coach to learn problem-solving skills to address current life challenges, plan activities, and complete home activities.
干预措施: Human Coached PST Intervention. (Behavioral)
Group 3: Optional (Delayed) Lumen Coached Group
Participants assigned to this group can choose to attend a Lumen Orientation session to receive training and a study iPad to complete 8 PST sessions with Coach Lumen after their follow-up assessment at 18 weeks. They will receive 8 Sunday mood assessment surveys to complete (4 every Sunday and then 4 every other Sunday).
干预措施: Optional (delayed) Lumen Coached PST (Waitlist control). (Behavioral)
结局指标
主要结局
Change From Baseline Functional Magnetic Resonance Scan at 18 Weeks
时间窗: Baseline, 18 weeks
Two neural targets defined a priori, specifically activation of the amygdala for nonconscious threat-related emotional reactivity and activation of the dorsal lateral prefrontal cortex (DLPFC) for cognitive control will be assessed using fMRI. The right DLPFC is the primary neural target, while the left DLPFC and bilateral amygdala are secondary neural targets. In the facial emotion viewing paradigm, facial expression stimuli are standardized black and white photographs of 8 identities (4 female, 4 male) with evoked expressions of threat-related emotions (fear, anger), loss-related emotions (sadness) and reward-related emotions (happiness), along with neutral. For the Go-NoGo paradigm, the 'Go' and 'NoGo' stimuli are presented for 500 ms each with an inter-stimulus interval of 750 ms. The beta weight is a standardized regression coefficient. Positive beta weights mean greater activation, and Negative beta weights mean less activation in the specific brain region being monitored.
次要结局
- Change From Baseline Hospital Anxiety and Depression Scale (HADS) at 18 Weeks(Baseline, 18 weeks)
- Change From Baseline Penn State Worry Questionnaire (PSWQ) at 18 Weeks(Baseline, 18 weeks)
- Change From Baseline Positive and Negative Affect Schedule (PANAS) at 18 Weeks(Baseline, 18 weeks)
- Change From Baseline Social Problem-Solving Inventory-Revised: Short Form (SPSI-R:S) at 18 Weeks(Baseline, 18 weeks)
- Change From Baseline Dysfunctional Attitudes Scale (DAS) at 18 Weeks(Baseline, 18 weeks)
- Change From Baseline Sheehan Disability Total Score at 18 Weeks(Baseline, 18 weeks)
- Change From Baseline Work Productivity and Activity Impairment Questionnaire (WPAI) at 18 Weeks(Baseline, 18 weeks)
- Change From Baseline Daily Mood (Positive Affect and Negative Affect) at 18 Weeks(Baseline and every 2 weeks (i.e., on weeks 2, 4, 6, 8, 10, 12, and 18))
- Change From Baseline Daily Stress at 18 Weeks(Baseline and every 2 weeks (i.e., on weeks 2, 4, 6, 8, 10, 12, and 18))
- Change From Baseline Daily Appraisal at 18 Weeks(Baseline and every 2 weeks (i.e., on weeks 2, 4, 6, 8, 10, 12, and 18))
研究者
Jun Ma
MD, PhD, Principal Investigator, Beth and George Vitoux Professor of Medicine
University of Illinois at Chicago