Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 12 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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).

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Caring Contacts + Introductory Phone Call (CC+)
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+)
    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.
Active Comparator
Caring Contacts (without phone call) (CC)
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)
    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.

Recruiting Locations

More Details

NCT ID
NCT04700137
Status
Not yet recruiting
Sponsor
St. Luke's Health System, Boise, Idaho

Study Contact

Anna K Radin, DrPH, MPH
208-381-8468
radina@slhs.org

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.