N/A
N=666
Mental Health Among Patients, Providers, and Staff During the COVID-19 Era
Covid19 · Mental Health
Bottom Line
View on ClinicalTrials.gov: NCT04700137 ↗Enrolled (actual)
666
Serious AEs
0.0%
Results posted
Jan 2024
Primary outcome: Primary: Loneliness as Measured by the National Institutes of Health (NIH) Toolbox Social Relationship Scale for Loneliness — 64.4; 64.4; 62.6; 62.5 T-score — p=0.31
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Caring Contacts Plus Introductory Phone Call (CC+) (Other); Caring Contacts without an introductory phone call (CC) (Other)
- Age
- Pediatric, Adult, Older Adult · 12+ yrs
- Sex
- All
- Sponsor
- St. Luke's Health System, Boise, Idaho
- Primary completion
- Jan 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Loneliness as Measured by the National Institutes of Health (NIH) Toolbox Social Relationship Scale for Loneliness |
64.4; 64.4; 62.6; 62.5; 61.9; 60.8 | 0.31 |
| SECONDARY Suicidal Ideation & Behavior as Measured by the Columbia Suicide Severity Rating Scale |
0.5; 0.4; 0.3; 0.4; 0.4; 0.6 | 0.05 |
| SECONDARY Depression as Measured by the Patient Health Questionnaire (PHQ-9) |
10.5; 10.0; 8.4; 8.6; 8.6; 7.9 | 0.45 |
| SECONDARY Anxiety as Measured by the Generalized Anxiety Disorder 7 Item Scale (GAD-7) |
9.3; 8.8; 7.8; 8.4; 7.9; 7.3 | 0.54 |
| SECONDARY Change From Baseline in Psychological Stress as Measured by the National Institutes of Health (NIH) Toolbox Stress and Self-Efficacy Scales Perceived Stress Measure |
60.7; 59.6; 58.5; 59.5; 56.5; 55.3 | 0.84 |
| SECONDARY Perceived Burdensomeness & Thwarted Belongingness as Measured by the Interpersonal Needs Questionnaire (INQ15) |
10.1; 9.2; 7.9; 8.0; 9.6; 9.5 | 0.38 |
| SECONDARY Number of Participants Reporting Suicide Attempts as Measured by the Columbia Suicide Severity Rating Scale & Completed Suicide |
0; 0; 1; 0; 0; 0 | — |
| SECONDARY 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 |
23; 13; 16; 6; 42; 38 | 0.12 |
| SECONDARY Number of Participants Who Attended Mental Healthcare Appointments: Self-Report |
119; 105; 124; 123 | 0.41 |
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.
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).
Data sourced from ClinicalTrials.gov (NCT04700137). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.