Studio di un consulente di intelligenza artificiale abilitato alla voce addestrato PST (SPEAC) per adulti con disagio emotivo (fase 2) (SPEAC)

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.

Lumen Intervention Orientation. Participants in the Lumen intervention arm attend a Lumen orientation visit (60 minutes) during which they will be given a Lumen intervention tutorial and receive a study iPad, configured to limit access to only the Lumen intervention enabled on the device. Before leaving, participants are scheduled for the first PST session with Coach Lumen. At the end of each PST session, participants are prompted to schedule their next session with Coach Lumen. They receive automated reminder notifications 1 day prior to their next session, on the session day, and have the opportunity to make up missed sessions. As needed, Lumen intervention orientations can be done remotely.

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.

Participants in the human coached PST arm will serve as active treatment controls given the demonstrated efficacy of human coached PST in depression and anxiety. They will complete 8 PST sessions with a human coach; first session in-person and remaining sessions via videoconferencing (i.e., Zoom preferred; with phone calls allowed) on the same 4 weekly and then 4 biweekly schedule as that for Lumen participants. Participants will receive a study iPad to use for their PST sessions via zoom. Participants also complete the PHQ-9 and GAD-7 during each session. Participants will receive a certificate of completion.

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).

Waitlist control participants will only complete assessments during the 18-week trial period. At the end of their 18-week assessment, they will have the option to complete 8 PST sessions on their assigned iPads.

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.

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 (psychological distress) ranges from 0 to 42, with higher score indicating more distress.

Penn State Worry Questionnaire (PSWQ) is a self-reported, 16-item, Likert-type scale that measures the trait of worry. Each item is related on a 1-5 scale. The total score of the scale ranges from 16 to 80, with higher scores indicating higher trait worry.

Positive and Negative Affect Schedule (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). Positive Affect scores can range from 10 - 50, with higher scores representing higher levels of positive affect. Negative affect scores can range from 10 - 50, with lower scores representing lower levels of negative affect.

Participants' problem solving abilities will be assessed using the Social Problem-Solving Inventory-Revised: Short Form (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). The total problem-solving ability score=(PPO raw score/5)+(20- NPO raw score)/5+ (RPS raw score/5)+(20- ICS raw score)/5+(20- AS raw score)/5. It ranged from 0 to 20, with the higher score indicating more productive problem-solving skills. Subscales scores (PPO, NPO, RPS, ICS, and AS) are raw scores without reversal. They range from 0 to 20, with the higher scores indicating the more positive and negative orientation, and the more rational, impulsive/careless, and avoidance style, respectively.

Dysfunctional Attitudes Scale (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) for a total scale range of 40 to 280. The higher the sum of the 40-items, the more dysfunctional attitudes an individual possesses.

The Sheehan Disability Scale is a validated questionnaire that measures functional disability and is sensitive to treatment effects in clinical trials. Patients rate the extent to which their symptoms impair work/school, social, and family life on a visual analog scale from 0 to 10. Total score is the sum of the three separate scores on work/school, social, and family life. Total scores range 0-30, with higher scores indicating greater functional impairment.

The Work Productivity and Activity Impairment questionnaire (WPAI) consists of 6 questions: 1 = currently employed; 2 = hours missed due to health problems; 3 = hours missed other reasons; 4 = hours actually worked; 5 = degree health affected productivity while working (using a 0 to 10 Visual Analogue Scale (VAS)); 6 = degree health affected productivity in regular unpaid activities (VAS). The recall period for the questions 2 to 6 is 7 days. Four main outcomes can be generated from the WPAI-GH and expressed in percentages by multiplying the following scores by 100: 1) percent work time missed due to health = Q2/(Q2 + Q4) for those who were currently employed; 2) percent impairment while working due to health = Q5/10 for those who were currently employed and actually worked in the past 7 days; 3) percent overall work impairment due to health Q2/(Q2 + Q4) + ((1 - Q2/(Q2 + Q4)) × (Q5/10)) for those who were currently employed; 4) percent activity impairment due to health Q6/10 for all.

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 18). Changes in weekly average from baseline to week 18 are reported below. During active treatment in the Lumen arm and the in-person PST arm, 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 (0 = Not at all, 6 = Extremely), with 4 measuring positive affect and 4 measuring negative affect. Positive affect score is mean of item scores, with higher scores indicating more positive affect. Negative affect score is mean of item scores, with higher scores indicating more negative affect.

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 18). Changes in weekly average from baseline to week 18 are reported below. During active treatment in the Lumen arm and the in-person PST arm, 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 the question "how stressful was your day today" (0 = Not at all, 6 = Extremely).

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 18). Changes in weekly average from baseline to week 18 are reported below. During active treatment in the Lumen arm and the in-person PST arm, 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. The appraisal question asks "To what degree were you able to accept your problem as normal or an expected part of everyday life?" (0 = Not at all, 6 = A great deal), which a higher score indicating a greater degree of ability to accept problem as normal or expected.

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. PHQ-9 will be administered before each PST session (in weeks 1, 2, 3, 4, 6, 8, 10, 12) in Luman and Human groups, and at the same schedule in the Waitlist group. Changes in PHQ-9 scores from session 1 to session 8 are reported below.

GAD-7 is a valid and reliable 7-question self-report measure assessing the severity of generalized anxiety symptoms over the past two weeks. Total scores range from 0 to 21, with higher scores indicating a greater degree of anxiety symptom severity. GAD-7 will be administered before each PST session (in weeks 1, 2, 3, 4, 6, 8, 10, 12) in Luman and Human groups, and at the same schedule in the Waitlist group. Changes in GAD-7 scores from session 1 to session 8 are reported below.

User Experience Questionnaire-Short version (UEQ-S) is a validated instrument containing 8 items from the 26 items of the original UEQ. UEQ-S measures user experience. From the UEQ-S survey, scale values were calculated by rescaling the survey responses to the range -3 to 3 and UEQ-S total score were calculated as mean of survey responses. UEQ-S total scores <-0.8 represented a negative evaluation, between -0.8 and 0.8 represented a neutral evaluation, and >0.8 represent a positive evaluation.

Adapted Working Alliance Inventory for digital coaching interventions (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). An overall score was calculated based on item means. A higher overall score reflected a greater treatment alliance.