N/A
Completed N=63
Study of a PST-Trained Voice-Enabled Artificial Intelligence Counselor (SPEAC) for Adults With Emotional Distress (Phase 1)
Source: ClinicalTrials.gov NCT04524104 ↗Enrolled (actual)
63
Serious AEs
3.2%
Results posted
Jun 2023
Primary outcomePrimary: Change in Activation of Left Amygdala From Baseline Functional Magnetic Resonance Scan at 16 Weeks — -0.07; -0.13 beta weights
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Activation of Left Amygdala From Baseline Functional Magnetic Resonance Scan at 16 Weeks |
-0.07; -0.13 | — |
| PRIMARY Change in Activation of Right Amygdala From Baseline Functional Magnetic Resonance Scan at 16 Weeks |
-0.14; -0.07 | — |
| PRIMARY Change in Activation of Left dlPFC From Baseline Functional Magnetic Resonance Scan at 16 Weeks |
-0.02; 0.09 | — |
| PRIMARY Change in Activation of Right dlPFC From Baseline Functional Magnetic Resonance Scan at 16 Weeks |
-0.10; 0.09 | — |
| SECONDARY Change From Baseline Hospital Anxiety and Depression Scale (HADS) Depression Score at 16 Weeks |
-1.85; 0.10 | — |
| SECONDARY Change From Baseline Hospital Anxiety and Depression Scale (HADS) Anxiety Score at 16 Weeks |
-2.25; 0.14 | — |
| SECONDARY Change From Baseline Hospital Anxiety and Depression Scale (HADS) Total Score at 16 Weeks |
-4.10; 0.24 | — |
| SECONDARY Change From Baseline Social Problem-Solving Inventory-Revised: Short Form (SPSI-R:S) at 16 Weeks |
0.83; 0.42 | — |
| SECONDARY Change From Baseline Dysfunctional Attitudes Scale (DAS) at 16 Weeks |
-12.8; -6.62 | — |
| SECONDARY Change From Baseline Penn State Worry Questionnaire (PSWQ) at 16 Weeks |
-3.90; -3.95 | — |
| SECONDARY Change From Baseline Positive Affect Score of the Positive and Negative Affect Schedule (PANAS) at 16 Weeks |
4.03; 2.43 | — |
| SECONDARY Change From Baseline Negative Affect Score of the Positive and Negative Affect Schedule (PANAS) at 16 Weeks |
-1.60; -0.90 | — |
| SECONDARY Change From Baseline Sheehan Disability Scale at 16 Weeks |
-3.70; -2.00 | — |
| SECONDARY Change From Baseline Percent Work Time Missed Due to Health at 16 Weeks |
5.08; 0.29 | — |
| SECONDARY Change From Baseline Percent Impairment While Working Due to Health at 16 Weeks |
-13.21; -7.33 | — |
| SECONDARY Change From Baseline Percent Overall Work Impairment Due to Health at 16 Weeks |
-8.82; -8.76 | — |
| SECONDARY Change From Baseline Percent Activity Impairment Due to Health at 16 Weeks |
9.33; 2.86 | — |
| SECONDARY Change From Baseline Physical Health Composite Score of the 12-item Short-Form Health Survey (SF12) at 16 Weeks |
1.37; -0.21 | — |
| SECONDARY Change From Baseline Mental Health Composite Score of the 12-item Short-Form Health Survey (SF12) at 16 Weeks |
3.57; 2.09 | — |
| SECONDARY Change From Baseline Daily Mood (Positive Affect) at 16 Weeks |
0.27; -0.50 | — |
| SECONDARY Change From Baseline Daily Mood (Negative Affect) at 16 Weeks |
-0.55; -0.07 | — |
| SECONDARY Change From Baseline Daily Stress at 16 Weeks |
-0.95; -0.15 | — |
| SECONDARY Change From Baseline Daily Appraisal at 16 Weeks |
0.05; -0.26 | — |
| SECONDARY Change in Depression Symptoms From First PST Session in Week 1 to Eighth Session in 12 Weeks |
-3.41; -0.25 | — |
| SECONDARY Change in Anxiety Symptoms From First PST Session in Week 1 to Eighth Session in 12 Weeks |
-3.15; -1.61 | — |
| SECONDARY Change in NASA Task Load Index (TLX) From First PST Session in Week 1 to Eighth Session in 12 Weeks |
2.21 | — |
| SECONDARY Change in User Experience Questionnaire-Short Version (UEQ-S) From First PST Session in Week 1 to Eighth Session in 12 Weeks |
-0.17 | — |
| SECONDARY 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 |
-0.15 | — |
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
Data sourced from ClinicalTrials.gov (NCT04524104). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.