Clinical Trials Directory

Trials / Completed

CompletedNCT04700137

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

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
666 (actual)
Sponsor
St. Luke's Health System, Boise, Idaho · Academic / Other
Sex
All
Age
12 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERCaring 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.
OTHERCaring 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.

Timeline

Start date
2021-01-18
Primary completion
2022-01-06
Completion
2022-01-06
First posted
2021-01-07
Last updated
2024-01-25
Results posted
2024-01-25

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT04700137. Inclusion in this directory is not an endorsement.