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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 666
- 试验地点
- 2
- 主要终点
- Loneliness as Measured by the National Institutes of Health (NIH) Toolbox Social Relationship Scale for Loneliness
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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
排除标准
- •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
- •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).
结局指标
主要结局
Loneliness as Measured by the National Institutes of Health (NIH) Toolbox Social Relationship Scale for Loneliness
时间窗: Baseline and 6 Months
The NIH Toolbox Social Relationship Scale for Loneliness is a validated method for measuring loneliness. Participants rate items on a 5-point scale, with options ranging from never (1) to always (5). This creates a raw score, which is then converted to a t-score, with higher scores indicating greater levels of loneliness. T-score of 50 represents the mean of the US general population (based on the 2010 Census) and 10 T-score units represents one standard deviation. A T-score of 60.7 or more (adults) or 60 or more (youth) indicates moderate to high levels of loneliness.
次要结局
- Anxiety as Measured by the Generalized Anxiety Disorder 7 Item Scale (GAD-7)(Baseline and 6 Months)
- Depression as Measured by the Patient Health Questionnaire (PHQ-9)(Baseline and 6 Months)
- Suicidal Ideation & Behavior as Measured by the Columbia Suicide Severity Rating Scale(Baseline and 6 Months)
- Change From Baseline in Psychological Stress as Measured by the National Institutes of Health (NIH) Toolbox Stress and Self-Efficacy Scales Perceived Stress Measure(Baseline and 6 Months)
- Perceived Burdensomeness & Thwarted Belongingness as Measured by the Interpersonal Needs Questionnaire (INQ15)(Baseline and 6 Months)
- Number of Participants Reporting Suicide Attempts as Measured by the Columbia Suicide Severity Rating Scale & Completed Suicide(Baseline and 6 Months)
- 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(Baseline and 6 Months)
- Number of Participants Who Attended Mental Healthcare Appointments: Self-Report(6 Months)
研究者
Anna Radin
Applied Research Scientist
St. Luke's Health System, Boise, Idaho