Mental Health Among Patients, Providers, and Staff During the COVID-19 Era (NCT04700137) | Clinical Trial Compass
CompletedNot Applicable
Mental Health Among Patients, Providers, and Staff During the COVID-19 Era
United States666 participantsStarted 2021-01-18
Plain-language 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.
Who can participate
Age range
12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 p…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Loneliness as Measured by the National Institutes of Health (NIH) Toolbox Social Relationship Scale for Loneliness