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Study of a PST-Trained Voice-Enabled Artificial Intelligence Counselor (SPEAC) for Adults With Emotional Distress (Phase 1) (SPEAC)

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ClinicalTrials.gov Identifier: NCT04524104
Recruitment Status : Recruiting
First Posted : August 24, 2020
Last Update Posted : April 29, 2021
Sponsor:
Collaborators:
Penn State University
Washington University School of Medicine
Stanford University
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Jun Ma, University of Illinois at Chicago

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.

Condition or disease Intervention/treatment Phase
Depression Anxiety Behavioral: Lumen Treatment Not Applicable

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 14 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, 14) - 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 14-week assessment is completed, at which time they will have the option to complete 8 PST sessions on their assigned iPads.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Study of a PST-Trained Voice-Enabled Artificial Intelligence Counselor (SPEAC) for Adults With Emotional Distress (Phase 1)
Actual Study Start Date : April 5, 2021
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : July 2, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: Lumen treatment
Participants will complete functional magnetic resonance imaging (fMRI) and self-report questionnaires at baseline and 14 weeks. Participant will receive an encrypted study iPad enabled with Lumen at baseline. They will complete 8 PST sessions beginning with 4 weekly and then 4 biweekly intervals (i.e., on weeks 1, 2, 3, 4, 6, 8, 10, 12) over 12 weeks on their assigned iPad. Participants will also complete naturalistic end-of-day assessments for 7 days every 2 weeks (on weeks 0, 2, 4, 6, 8, 10, 12, 14), that is, 8 time series. Additionally, participants will complete depressive and anxiety symptoms questionnaire and user experience surveys at all PST sessions.
Behavioral: Lumen Treatment
the virtual AI agent, Lumen, via an iPad-based application. Each participant will receive a locked, encrypted study iPad installed with Lumen. They will complete 8 problem solving therapy (PST) sessions beginning with 4 weekly and then 4 biweekly intervals over 12 weeks on their assigned iPad.

No Intervention: Waitlist Control

Participants will complete functional magnetic resonance imaging (fMRI) and self-report questionnaires at Baseline and 14 weeks.

Participant will receive an encrypted study iPad at baseline. Participants will complete naturalistic end-of-day assessments for 7 days every 2 weeks (on weeks 0, 2, 4, 6, 8, 10, 12, 14), that is, 8 time series.

Participants in the waitlist control arm will only complete assessments but 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 14-week assessment is completed, at which time they will have the option to complete 8 PST sessions on their assigned iPads.




Primary Outcome Measures :
  1. Change from Baseline Functional Magnetic Resonance Scan at 14 weeks [ Time Frame: Baseline, 14 weeks ]
    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.


Secondary Outcome Measures :
  1. Change from baseline Penn State Worry Questionnaire (PSWQ) at 14 weeks [ Time Frame: Baseline, 14 weeks ]
    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.

  2. Change from baseline Positive and Negative Affect Schedule (PANAS) at 14 weeks [ Time Frame: Baseline, 14 weeks ]
    PANAS consists of two 10-item self-reported scales to measure positive and negative affect. Each item asks about the extent one has felt a positive or negative feeling on a 5-point scale of 1 (not at all) to 5 (very much). Cronbach's alpha is 0.86-0.90 for the positive affect items and 0.84-0.87 for the negative affect items when reporting affect across time frames from at this moment to a year. Test-retest correlation is 0.68 for positive affect and 0.71 for negative affect when reporting affect in general over an 8-week period.

  3. Change from baseline Social Problem-Solving Inventory-Revised: Short Form (SPSI-R:S) at 14 weeks [ Time Frame: Baseline, 14 weeks ]
    Participants' problem solving abilities will be assessed using the reliable and valid SPSI-R:S that contains 25 items in the following 5 subscales: positive problem orientation (PPO), negative problem orientation (NPO), rational problem solving (RPS), impulsive/careless style (ICS), and avoidance style (AS). Each item is rated on a 5-point scale ranging from "not at all true of me" (0) to "extremely true of me" (4). SPSI-R:S is a short version of the long SPSI-R:L form which has Cronbach's alpha coefficient of 0.95 for the total score and of 0.67-0.92 for subscales.

  4. Change from baseline Dysfunctional Attitudes Scale (DAS) at 14 weeks [ Time Frame: Baseline, 14 weeks ]
    DAS (Form A) is a 40-item self-reported scale that measures the presence and intensity of dysfunctional attitudes. Each item is rated a 7-point Likert scale (7 = fully agree; 1 = fully disagree). The higher the sum of the 40-items, the more dysfunctional attitudes an individual possesses. Cronbach's alpha is 0.89-0.92 and test-retest correlation is 0.73 over a 6-week period. DAS was found to be significantly correlated with the Beck Depression Inventory in an adult population (r=0.41)

  5. Change from baseline Hospital Anxiety and Depression Scale (HADS) at 14 weeks [ Time Frame: Baseline, 14 weeks ]
    HADS, including 7 questions for anxiety and 7 questions for depression, measures self-reported anxiety and depression in a general medical population of patients. Each item on the questionnaire is scored from 0-3 and the score for either anxiety or depression ranges between 0 and 21 with the following categories: normal 0-7, mild 8-10, moderate 11-14, and severe 15-21. Total score for the entire scale (emotional distress) ranges from 0 to 42, with higher score indicating more distress. Cronbach's alpha coefficients range from 0.78-0.93 for the anxiety subscale and from 0.82-0.90 for the depression subscale. Test-retest correlations are ≥0.80 after ≤2 weeks. Correlations of the anxiety and depression subscales with commonly used anxiety and depression measures (e.g., Beck Depression Inventory, Patient Health Questionnaire, State-Trait Anxiety Inventory, Symptom Checklist-90-Revised) vary between 0.60 (good) and 0.80 (very good).

  6. Change from baseline Sheehan Disability Scale at 14 weeks [ Time Frame: Baseline, 14 weeks ]
    The Sheehan Disability Scale is a validated questionnaire that measures functional disability and is sensitive to treatment effects in clinical trials. Cronbach's alpha is 0.89. Patients rate the extent to which their symptoms impair work/school, social, and family life on a visual analog scale from 0 to 10 and answer the number of days when their symptoms cause them to miss work/school and be unproductive at work/school.

  7. Change from baseline Absenteeism and presenteeism questions of the WHO Heath and Work Performance Questionnaire (HPQ) at 14 weeks [ Time Frame: Baseline, 14 weeks ]
    The absenteeism questions solicit self-reported information in both 7-day and 4-week estimates. There are 8 questions inquiring the number of hours participants worked in the past 7 days and 4 weeks, the number of hours they are expected to work in a typical week, the number of entire and partial days they missed work due to health problems and other reason in the past 4 weeks, and the days they come in early, go home late, or work on a day off in the past 4 weeks. The 3 presenteeism questions ask the job performance of most workers usually and of the participant over the past year or two and during the past 4 weeks on a 0-10 scale (with 0 indicating worst performance and 10 indicating top performance). Associations of self-reported work absence with payroll work absence range from 0.81-0.87 for one-week recall and 0.71-0.79 for 4-week recall.

  8. Change from baseline 12-item Short-Form Health Survey (SF12) at 14 weeks [ Time Frame: Baseline, 14 weeks ]
    The SF-12 is a 12-item version of the SF-36 that measures overall health-related quality of life. Physical and mental health composite scores are computed using the scores of 12 questions and range from 0 to 100, with 0 indicating the lowest level of health and 100 indicating the highest level of health. Test-retest correlation is 0.89 for the physical health subscale and 0.76 for the mental health subscale

  9. Change from baseline Daily Mood at 14 weeks [ Time Frame: From Baseline to every 2 week, up to 14 weeks ]
    Daily end-of-day assessments will be captured over a one-week period at baseline and every 2 weeks (i.e., on weeks 2, 4, 6, 8, 10, 12, and 14). During active treatment in the Lumen arm (Studies 1 & 2) or the in-person PST arm (Study 2), this will occur for 3 days prior to, the day of, and for 3 days after a scheduled PST session. For waitlist controls, this will occur for 7 days starting on Sunday of each assigned week. Daily mood will be measured using 8 mood items that capture both the arousal and valence components of the circumplex model of affect

  10. Change from baseline Daily Stress at 14 weeks [ Time Frame: From Baseline to every 2 weeks, up to 14 weeks ]
    Daily end-of-day assessments will be captured over a one-week period at baseline and every 2 weeks (i.e., on weeks 2, 4, 6, 8, 10, 12, and 14). During active treatment in the Lumen arm (Studies 1 & 2) or the in-person PST arm (Study 2), this will occur for 3 days prior to, the day of, and for 3 days after a scheduled PST session. For waitlist controls, this will occur for 7 days starting on Sunday of each assigned week. Daily stress will be assessed by report of stressors on that day; when stress is reported, the nature/characteristics of the stressor and response will be assessed. The type of stress will be assessed using a list of 12 categories of social problems, followed by reporting the perceived severity of the most salient stressor that day, and the degree to which the participant has had stressor-related thoughts (e.g., intrusive thoughts). Finally, we will capture an overall perceived stress report for each day (regardless of the number and type of stressors reported).

  11. Change from baseline Daily Appraisal and Coping at 14 weeks [ Time Frame: From Baseline to every 2 weeks, up to 14 weeks ]
    Daily end-of-day assessments will be captured over a one-week period at baseline and every 2 weeks (i.e., on weeks 2, 4, 6, 8, 10, 12, and 14). During active treatment in the Lumen arm (Studies 1 & 2) or the in-person PST arm (Study 2), this will occur for 3 days prior to, the day of, and for 3 days after a scheduled PST session. For waitlist controls, this will occur for 7 days starting on Sunday of each assigned week. Two components of these assessments will capture a summary of appraisal and coping processes associated with daily experiences. The appraisal items will focus on assessing "problem orientation" or the general awareness and appraisals of problems during the day. The coping items will focus on assessing "problem-solving style" or the methods of planning and coping with the most salient problem experienced during the day.

  12. Change in Depression symptoms from start of first PST session in week 1 to 14 weeks [ Time Frame: From start of first PST session in week 1 to week (2, 3, 4, 6, 8, 10, 12) up to 12 weeks ]
    PHQ-9 is a self-administered instrument for screening, diagnosing, monitoring, and measuring the severity of depression. It rates the frequency of symptoms as "0" (not at all) to "3" (nearly every day) and has been validated for use in primary care. The PHQ-9 total score ranges from 0 to 27 and is categorized as follows: None or minimal depression 0-4, Mild depression 5-9, Moderate depression 10-14, Moderately severe depression 15-19, and Severe depression 20-27. Cronbach's alpha coefficients range from 0.86 to 0.89 and test-retest correlations range from 0.84-0.95 within 48 hours and from 0.81-0.96 at 7-day reassessment. PHQ-9 scores were found to be highly correlated with Beck Depression Inventory scores in the general population (r=0.73).

  13. Change in Anxiety Symptoms from start of first PST session in week 1 to 14 weeks [ Time Frame: From start of first PST session in week 1 to week (2, 3, 4, 6, 8, 10, 12) , up to 12 weeks ]
    GAD-7 is a valid and reliable 7-question scale to screen for 4 anxiety disorders: Post Traumatic Stress Disorder, Panic Disorder, Generalized Anxiety Disorder, and Social Phobia. A score of ≥10 indicates a high probability of 1 or more of these disorders. Cronbach's alpha is 0.92 and test-retest correlation is 0.83. GAD-7 scores also correlate highly with scores of 2 commonly-used anxiety scales: the Beck Anxiety Inventory (r=0.72) and the anxiety subscale of the Symptom Checklist-90 (r=0.74).

  14. Change in NASA Task Load Index (TLX) From end of first PST session in week 1 to 12 weeks [ Time Frame: From end of first PST session in week 1 to week (in week, 2, 3, 4, 6, 8, 10, 12), up to 12 weeks ]
    The NASA TLX has become the gold standard for measuring subjective workload. It gives an overall workload score based on a weighted average of ratings on 6 subscales: Mental Demands, Physical Demands, Temporal Demands, Performance, Effort, and Frustration. Mental and Physical Demand subscales measure how mentally and physically demanding the task was, respectively. Temporal Demand subscale measures how hurried was the pace of the task. Performance subscale measures how successful the participant was in accomplishing the task. Effort subscale measures how hard the participant had to work to accomplish the task. Frustration subscale measures how irritated, stressed, and annoyed the participant was. It is a two-part evaluation procedure consisting of both weights and ratings. First, the weight of the contribution of each factor to the workload of a task is evaluated. Then, each subscale is rated on a 12-cm line divided into 20 equal intervals anchored by bipolar descriptors (low/high).

  15. Change in User Experience Questionnaire-Short version (UEQ-S) From end of first PST session in week 1 to 12 weeks [ Time Frame: From end first PST session in week 1 to week (in week 2, 3, 4, 6, 8, 10, 12), up to 12 weeks ]
    UEQ-S is a validated instrument containing 8 items from the 26 items of the original UEQ. The 8 items are grouped into 2 subscales, pragmatic and hedonic quality (4 items each). A total value reflects the overall user experience. Cronbach' alpha values are 0.85 for the pragmatic quality subscale and 0.81 for the hedonic quality subscale

  16. Change in Adapted Working Alliance Inventory for digital coaching interventions (WAI-Tech) From end of first PST session in week 1 to 12 weeks [ Time Frame: From end of first PST session in week 1 to week (in week 2, 3, 4, 6, 8, 10, 12), up to 12 weeks ]
    WAI-Tech was based closely on the original 36-item WAI and uses a parallel set of 36 items rated on a 7-point scale (1 = "never" to 7 = "always") to measure the level of alliance between patient and digital coach along 3 domains: Task (12 items), Bond (12 items), and Goal (12 items). The Task subscale measures how responsive the digital coach was to the patient's focus or need. The Bond subscale measures the degree of the affective bond between patient and digital coach. The Goal subscale measures the extent to which goals were important, mutual, and capable of being accomplished. The WAI-Tech yields 3 subscale scores and one overall score. Cronbach's alpha coefficients are 0.92 for the total scale, 0.84 for the Task subscale, 0.78 for the Bond subscale, and 0.75 for the Goal subscale.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04524104


Contacts
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Contact: Jun Ma, MD, PhD 312-413-9830 maj2015@uic.edu
Contact: Amruta Barve, MPH 312-413-8211 amruta@uic.edu

Locations
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United States, Illinois
Institute for Health Research and Policy (IHRP), Center for Health Behavior Research Recruiting
Chicago, Illinois, United States, 60608
Contact: Jun Ma, MD, PhD         
UIMC Advanced Imaging Center Recruiting
Chicago, Illinois, United States, 60612
Contact: Jun Ma         
Sponsors and Collaborators
University of Illinois at Chicago
Penn State University
Washington University School of Medicine
Stanford University
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Jun Ma, MD, PhD University of Illinois at Chicago
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Responsible Party: Jun Ma, MD, PhD, Beth and George Vitoux Professor of Medicine, University of Illinois at Chicago
ClinicalTrials.gov Identifier: NCT04524104    
Other Study ID Numbers: 2020-0918
1R61MH119237-01A1 ( U.S. NIH Grant/Contract )
First Posted: August 24, 2020    Key Record Dates
Last Update Posted: April 29, 2021
Last Verified: April 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Depression
Behavioral Symptoms