Clinical trial NCT04700137: Mental Health Among Patients, Providers, and Staff During the COVID-19 Era
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Covid19
Mental Health
Keywords: Loneliness
Anxiety
Depression
Suicidal Ideation
Social Distancing
Mental Distress
Pandemic
Caring Contacts
Healthcare Staff
Healthcare Providers
Brief Contact Intervention
Adults
Adolescents
Lead sponsor: St. Luke's Health System, Boise, Idaho
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
name: Idaho Crisis & Suicide Hotline
name: University of Washington
First posted: 2021-01-07
Enrollment: 666
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: Loneliness as Measured by the National Institutes of Health (NIH) Toolbox Social Relationship Scale for Loneliness
timeFrame: Baseline and 6 Months
Secondary outcomes:
measure: Suicidal Ideation & Behavior as Measured by the Columbia Suicide Severity Rating Scale
timeFrame: Baseline and 6 Months
measure: Depression as Measured by the Patient Health Questionnaire (PHQ-9)
timeFrame: Baseline and 6 Months
measure: Anxiety as Measured by the Generalized Anxiety Disorder 7 Item Scale (GAD-7)
timeFrame: Baseline and 6 Months
measure: Change From Baseline in Psychological Stress as Measured by the National Institutes of Health (NIH) Toolbox Stress and Self-Efficacy Scales Perceived Stress Measure
timeFrame: Baseline and 6 Months
measure: Perceived Burdensomeness & Thwarted Belongingness as Measured by the Interpersonal Needs Questionnaire (INQ15)
timeFrame: Baseline and 6 Months
measure: Number of Participants Reporting Suicide Attempts as Measured by the Columbia Suicide Severity Rating Scale & Completed Suicide
timeFrame: Baseline and 6 Months
measure: Number of Participants Reporting Increased Alcohol, Tobacco, Marijuana, and Illicit Drug Use as Measured by Questions Adapted From Youth Risk Behavior Survey and Related to COVID-19
timeFrame: Baseline and 6 Months
measure: Number of Participants Who Attended Mental Healthcare Appointments: Self-Report
timeFrame: 6 Months
Other outcomes:
Locations:
city: Boise
country: United States
facility: St. Luke's Health System
state: Idaho
Study officials:
affiliation: St. Luke's Health System
name: Anna K Radin, DrPH, MPH
role: PRINCIPAL_INVESTIGATOR
References: