Mental Health Among Patients, Providers, and Staff During the COVID-19 Era

Study Overview
=================
Brief Summary
-----------------
The Mental Health Among Patients, Providers, and Staff (MHAPPS) Study is designed to study how the COVID-19 pandemic has affected mental health and wellbeing, and how to support mental health while minimizing the burden on the healthcare system. The study will enroll adults and adolescents who have had a primary care visit in the last 12 months, as well as healthcare providers and staff from a large health system in Idaho. The study will include: Aim 1: a cross sectional survey to measure the prevalence of various measures of mental distress and how they are associated with COVID-19-related factors; and Aim 2: a randomized controlled trial comparing the effectiveness of two versions of a Caring Contacts intervention to reduce loneliness and mental distress.

Detailed Description
-----------------
Approximately 4,800 participants will complete the Aim 1 survey. The Caring Contacts intervention involves sending a series of brief, non-demanding, supportive text messages to the participant. One intervention arm will receive an introductory phone call and the caring text messages (CC+); the second intervention arm will only receive the same caring text messages (CC). The clinical trial will enroll a subset of 660 participants who report elevated levels of loneliness, suicide ideation, or other mental distress in the Aim 1 survey. Enrollment will be stratified by population (providers and employees; patients) with 165 per intervention arm in each stratum. The investigators hypothesize that delivering the Caring Contacts intervention with an introductory phone call will yield better mental health outcomes than delivering the Caring Contacts intervention with no introductory phone call. This will be the first published data directly comparing the effectiveness of two versions of the Caring Contacts intervention with individuals who report loneliness or other mental distress. The overall goal of the MHAPPS study is to better understand the mental health impact of COVID-19 and to determine how health systems can most effectively support mental health at scale among providers, staff, and patients in the COVID-19 era and beyond. This research is being conducted by a team including health system-based researchers, clinicians, other frontline healthcare workers, and administrators; academic researchers; follow-up specialists and administrators at the Idaho Suicide Prevention Hotline, and an advisory board of people with lived experience with suicide.

Official Title
-----------------
Investigating the Mental Health Impact of COVID-19 and Comparing the Effectiveness of Two Caring Contact Interventions on Patients, Providers, and Staff of St. Luke's Health System

Conditions
-----------------
Covid19, Mental Health

Intervention / Treatment
-----------------
* Other: Caring Contacts Plus Introductory Phone Call (CC+)
* Other: Caring Contacts without an introductory phone call (CC)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aim 1: Provider & Employee Inclusion Criteria Provider or Employee at St. Luke's Health System Adults ≥ 18 years of age Proficient in spoken and written English language Patient Inclusion Criteria Patient at a St. Luke's Health System primary care site Current MyChart account user Adults ≥18 years of age Minors 12-17 years of age Proficient in spoken and written English language Aim 2: Provider & Employee Inclusion Criteria Moderate or high score for loneliness, suicide ideation, psychological stress, anxiety, or depression: NIH Toolkit Loneliness raw score of 13 or greater or C-SSRS score of 3 or greater; or NIH Toolkit Perceived Stress raw score of 31 or greater for adults; or GAD7 score of 11 or greater; or PHQ9 score of 10 or greater Access to a phone for the duration of the study with the ability to receive text messages and phone calls Patient Inclusion Criteria Moderate or high score for loneliness, suicide ideation, psychological stress, anxiety, or depression: NIH Toolkit Loneliness raw score of 13 or greater for adults or 16 or greater for adolescents; or C-SSRS score of 3 or greater; or GAD7 score of 11 or greater; or PHQ9 score of 10 or greater; or NIH Toolkit Stress raw score of 31 or greater for adults or 33 or greater for adolescents [Note: validated youth versions of the NIH Toolkit assessments (loneliness and perceived stress), and PHQ-A tools will be used for adolescents; the C-SSRS and GAD7 tools are validated for use with both adults and adolescents.] Access to a phone for the duration of the study with the ability to receive text messages and phone calls Exclusion Criteria: Aim 1: Provider & Employee Exclusion Criteria Individuals who are unable or unwilling to provide informed consent to participate Individuals who are study staff for this study or the SPARC Trial Patient Exclusion Criteria Individuals who are unable or unwilling to provide informed consent to participate. Individuals who are participants in the SPARC Trial Individuals who have not had a primary care visit in the past 12 months Aim 2: Provider & Employee Exclusion Criteria Individuals who are unable or unwilling to provide informed consent to participate Individuals who are in acute crisis as determined by the person conducting the consent process Individuals who are study staff for this study or the SPARC Trial Individuals who are enrolled as participants in the SPARC comparative effectiveness clinical trial (SPARC Aim 1). Providers or employees who received training related to SPARC and/or who completed the SPARC provider satisfaction survey are not excluded from participating in MHAPPS Patient Exclusion Criteria Patients who are unable or unwilling to provide informed consent/assent to participate (or whose legally authorized representative is unable or unwilling to provide consent in the case of adolescents). Examples may include but are not limited to patients who present with acute or chronic cognitive impairment that would preclude their ability to consent (i.e. acute psychosis, intoxication, or intellectual disability).

Ages Eligible for Study
-----------------
Minimum Age: 12 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Caring Contacts + Introductory Phone Call (CC+)<br>Healthcare provider and staff participants who are randomized to both caring text messages and an introductory phone call. Adult and adolescent participants who are randomized to both caring text messages and an introductory phone call. | Other: Caring Contacts Plus Introductory Phone Call (CC+)<br>* One introductory semi-structured caring phone conversation with a follow-up specialist to check-in, establish a personal connection, and provide resources at the 0-2 week time-point followed by 11 non-demanding, caring text or email messages sent over the course of 6 months.<br>|
| Active Comparator: Caring Contacts (without phone call) (CC)<br>Healthcare provider and staff participants who are randomized to only caring text messages. Adult and adolescent patient participants who are randomized to only caring text messages. | Other: Caring Contacts without an introductory phone call (CC)<br>* Eleven non-demanding, caring text or email messages sent over the course of 6 months. Participants will not know or have spoken to the follow-up specialist who sends the caring messages.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Loneliness as measured by the National Institutes of Health (NIH) Toolbox Social Relationship Scale for Loneliness | The NIH Toolbox Social Relationship Scale for Loneliness is a validated method for measuring loneliness. Participants rate items on a 5-point scale, with options ranging from never (1) to always (5). This creates a raw score, which is then converted to a t-score, with higher scores indicating greater levels of loneliness. | Baseline and 6 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Suicidal Ideation & Behavior as measured by the Columbia Suicide Severity Rating Scale | The Columbia Suicide Severity Rating Scale (C-SSRS) 6-item screener (self-assessment lifetime-recent (baseline) and since last visit (6 months) for Primary Care settings versions will be used). The C-SSRS is a validated tool to assess suicidality. C-SSRS score is determined based on the highest question number to which the participant responds yes. For example, a score of 5 would be assigned to a participant who responded yes to Question 5 and any or all preceding questions. Higher scores are indicative of greater risk for suicide. The change from baseline score will be used to determine a change in suicidal ideation and behavior. | Baseline and 6 Months | 
| Suicide Attempts & Self-Harm as measured by the Columbia Suicide Severity Rating Scale | Three elements of the full version of the C-SSRS (lifetime-recent (baseline) and since last visit (6 months)) have been complied to create a Suicide Attempts Survey. These will measure self-reported aborted or self-interrupted suicide attempts, interrupted suicide attempts, and actual suicide attempts. Non-lethal self-harm and lethal means used for attempts or completions will also be collected. These elements will not be included in the C-SSRS score but will be compared across the intervention groups. Vital records will be used to measure suicide completion. | Baseline and 6 Months | 
| Perceived Burdensomeness & Thwarted Belongingness as measured by the Interpersonal Needs Questionnaire (INQ15) | The Interpersonal Needs Questionnaire (INQ) was developed from the Interpersonal Theory of Suicide and the 15-item version is a validated tool to measure both perceived burdensomeness and thwarted belongingness which are proximal causes of desire for suicide. The INQ15 asks respondents to indicate how true each is for them on a scale of 1 to 7, with 1 being not true at all for me and 7 being very true for me. The ratings are compiled into a score with higher scores indicating higher levels of perceived burdensomeness and thwarted belongingness. | Baseline and 6 Months | 
| Psychological Stress as measured by the National Institutes of Health (NIH) Toolbox Stress and Self-Efficacy Scales Perceived Stress measure | The National Institute of Health (NIH) Toolbox Self-Efficacy Scales Perceived Stress measure is a validated tool to measure the stress and coping resources of an individual. The measure is comprised of ten items which are scored and granted a t-score specific to adult or adolescent participants. Higher t-scores are indicative of higher levels of stress. | Baseline and 6 Months | 
| Alcohol and Illicit Drug Use as measured by questions adapted from Youth Risk Behavior Survey and related to COVID-19 | The questions are adapted from the Youth Risk Behavior Survey and will contain additional questions to measure self-reported changes in alcohol or illicit-drug use since the beginning of the COVID-19 pandemic. | Baseline and 6 Months | 
| Depression as measured by the Patient Health Questionnaire (PHQ-9) | The PHQ-9 is a widely used and validated tool to screen for depression in primary care and other non-psychiatric settings. The tool is composed of 9 questions each with a response of 0-3 which generate a score from 0-27 with higher scores indicating a greater degree of depression. Scores are categorized in the following manner: a score of 5-9 is considered minimal depression, 10-14 is considered mild major, 15-19 is moderate major, and ≥20 is severe major. | Baseline and 6 Months | 
| Anxiety as measured by the Generalized Anxiety Disorder 7 Item Scale (GAD-7) | Symptoms of anxiety will be assessed using the GAD-7, a brief self-report scale frequently used in the identification of Generalized Anxiety Disorder. The tool is composed of seven items, which are rated 0-3 to generate a score from 0-21. Higher scores indicate a greater severity of generalized anxiety symptoms. | Baseline and 6 Months | 
| Attendance at Mental Healthcare Appointments: Self-Report | Participant engagement in outpatient mental health services will be measured as dichotomous variables through self-report. | 6 Months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Loneliness, Anxiety, Depression, Suicidal Ideation, Adolescents, Social Distancing, Mental Distress, Pandemic, Caring Contacts, Healthcare Staff, Healthcare Providers, Brief Contact Intervention, Adults