Depression Clinical Trial
— SPEACOfficial title:
Study of a PST-Trained Voice-Enabled Artificial Intelligence Counselor(SPEAC) for Adults With Emotional Distress (Phase 2)
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.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | July 2, 2025 |
Est. primary completion date | December 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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or psychotherapy (individual or professionally led group therapy) for depression or anxiety (note: participants are not withdrawn post-randomization if they begin pharmacotherapy drugs or start psychotherapy during the study.)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 |
Country | Name | City | State |
---|---|---|---|
United States | Department of Medicine, Vitoux Program on Aging and Prevention | Chicago | Illinois |
United States | UIMC Advanced Imaging Center | Chicago | Illinois |
Lead Sponsor | Collaborator |
---|---|
University of Illinois at Chicago | National Institute of Mental Health (NIMH), Penn State University, Stanford University, Washington University School of Medicine |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from Baseline Functional Magnetic Resonance Scan at 18 weeks | Outcome Description Two neural targets defined a priori, specifically activation of the amygdala for nonconscious threat-related emotional reactivity and activation of the DLPFC for cognitive control will be assessed using fMRI. 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 2 paradigms are empirically validated probes of emotional reactivity and cognitive control, respectively. | Baseline, 18 weeks | |
Secondary | Change from baseline Penn State Worry Questionnaire (PSWQ) at 18 weeks | Outcome Description PSWQ is a self-reported, 16-item, Likert-type scale that measures the trait of worry. Cronbach's alpha is 0.93-0.95 and test-retest correlation is 0.92 after 8-10 weeks. In addition, PSWQ significantly discriminates levels of generalized anxiety disorder (GAD) and GAD versus PTSD. | Baseline, 18 weeks |
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