Covid19, Mental Health
Conditions
Keywords
Loneliness, Anxiety, Depression, Suicidal Ideation, Social Distancing, Mental Distress, Pandemic, Caring Contacts, Healthcare Staff, Healthcare Providers, Brief Contact Intervention, Adults, Adolescents
Brief 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.
Interventions
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.
Sponsors
Patient-Centered Outcomes Research Institute
Idaho Crisis & Suicide Hotline
University of Washington
St. Luke's Health System, Boise, Idaho
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Loneliness as Measured by the National Institutes of Health (NIH) Toolbox Social Relationship Scale for Loneliness | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Depression as Measured by the Patient Health Questionnaire (PHQ-9) | Baseline and 6 Months | The PHQ-9 is a widely used and validated tool to screen for depression in primary care and other non-psychiatric settings. The tool is composed of 9 questions each with a response of 0-3 which generate a score from 0-27 with higher scores indicating a greater degree of depression. Scores are categorized in the following manner: a score of 5-9 is considered minimal depression, 10-14 is considered mild major, 15-19 is moderate major, and ≥20 is severe major. |
| Anxiety as Measured by the Generalized Anxiety Disorder 7 Item Scale (GAD-7) | Baseline and 6 Months | Symptoms of anxiety will be assessed using the GAD-7, a brief self-report scale frequently used in the identification of Generalized Anxiety Disorder. The tool is composed of seven items, which are rated 0-3 to generate a score from 0-21. Higher scores indicate a greater severity of generalized anxiety symptoms. Scores of 11 and higher indicate moderate to high anxiety. |
| 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 | The National Institute of Health (NIH) Toolbox Self-Efficacy Scales Perceived Stress measure is a validated tool to measure the stress and coping resources of an individual. The measure is comprised of ten items which are scored and granted a t-score specific to adult or adolescent participants. Higher t-scores are indicative of higher levels of stress. 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 60.5 or more for adults or 60.8 or more in adolescents indicates moderate to high levels of stress. |
| Suicidal Ideation & Behavior as Measured by the Columbia Suicide Severity Rating Scale | Baseline and 6 Months | The Columbia Suicide Severity Rating Scale (C-SSRS) 6-item screener (self-assessment lifetime-recent (baseline) and since last visit (6 months) for Primary Care settings versions will be used). The C-SSRS is a validated tool to assess suicidality. C-SSRS score is determined based on the highest question number to which the participant responds yes. For example, a score of 5 would be assigned to a participant who responded yes to Question 5 and any or all preceding questions. Higher scores are indicative of greater risk for suicide. C-SSRS screener scores range from 0 to 6, with higher scores indicative of higher suicide risk. Scores of 3 and higher indicate moderate to high risk for suicide. |
| Number of Participants Reporting Suicide Attempts as Measured by the Columbia Suicide Severity Rating Scale & Completed Suicide | Baseline and 6 Months | Three elements of the full version of the Columbia Suicide Severity Rating Scale (C-SSRS) (lifetime-recent (baseline) and since last visit (6 months)) were complied to create a Suicide Attempts Survey. These measured self-reported aborted or self-interrupted suicide attempts, interrupted suicide attempts, and actual suicide attempts. Non-lethal self-harm and lethal means used for attempts or completions were also collected. These elements were not included in the C-SSRS score but were compared across the intervention groups. Medical records were used to measure suicide completion. |
| 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 | The questions are adapted from the Youth Risk Behavior Survey and will contain additional questions to measure self-reported changes in alcohol or illicit-drug use since the beginning of the COVID-19 pandemic. |
| Number of Participants Who Attended Mental Healthcare Appointments: Self-Report | 6 Months | Participant engagement in outpatient mental health services will be measured as a dichotomous variable through self-report. |
| Perceived Burdensomeness & Thwarted Belongingness as Measured by the Interpersonal Needs Questionnaire (INQ15) | Baseline and 6 Months | The Interpersonal Needs Questionnaire (INQ) was developed from the Interpersonal Theory of Suicide and the 15-item version (INQ15) is a validated tool to measure both perceived burdensomeness (PB) (6 items, scores range from 6 to 42) and thwarted belongingness (TB) (9 items; scores range from 9 to 63). Individuals provide a self-report response to each item ranging from 1 (Not at all true for me) to 7 (Very true for me). The appropriate items are reverse coded, and items are summed to calculate the TB and PB subscale scores with higher scores indicating greater TB and PB. Clinical Cutoff scores predicting desire for death are 35 or greater for TB and 19 or greater for PB. Clinical cutoff scores predicting desire for suicide are 50 or greater for TB and 30 or greater for PB. |
Countries
United States
Participant flow
Recruitment details
Recruitment occurred between January 2021 and July 2021. All recruitment was completed virtually, with invitations to participate sent via email and via the electronic health record messaging service.
Pre-assignment details
Randomization occurred once a potential participant joined a study enrollment phone call but before they consented to participate. This approach was practical given the electronic nature of the informed consent process and was recommended by the Data & Safety Monitoring Committee as a way to include a description in writing of the assigned intervention on the informed consent form while masking participants to the details of the intervention arm to which they were not assigned.
Participants by arm
| Arm | Count |
|---|---|
| Patients - CC Patients randomized to Caring Contacts without an introductory phone call (CC) intervention arm | 166 |
| Patients - CC+ Patients randomized to Caring Contacts with an introductory phone call (CC+) intervention arm | 165 |
| Healthcare Providers/Staff - CC Healthcare providers and staff randomized to Caring Contacts without an introductory phone call (CC) intervention arm | 168 |
| Healthcare Providers/Staff - CC+ Healthcare providers and staff randomized to Caring Contacts with an introductory phone call (CC+) intervention arm | 167 |
| Total | 666 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Death | 0 | 0 | 1 | 0 |
| Overall Study | Lost to Follow-up | 1 | 6 | 1 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Healthcare Providers/Staff - CC+ | Total | Patients - CC | Patients - CC+ | Healthcare Providers/Staff - CC |
|---|---|---|---|---|---|
| Age, Continuous | 39.5 years | 41 years | 44.8 years STANDARD_DEVIATION 17 | 47.2 years STANDARD_DEVIATION 15.8 | 42.1 years STANDARD_DEVIATION 12.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 19 Participants | 51 Participants | 9 Participants | 11 Participants | 12 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 145 Participants | 608 Participants | 156 Participants | 154 Participants | 153 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants | 7 Participants | 1 Participants | 0 Participants | 3 Participants |
| Health System Employee Type Nursing | 67 Participants | 124 Participants | — | — | 57 Participants |
| Health System Employee Type Office Work & Educators | 60 Participants | 122 Participants | — | — | 62 Participants |
| Health System Employee Type Other | 1 Participants | 2 Participants | — | — | 1 Participants |
| Health System Employee Type Pharmacy, Patient Access Specialists, Lab | 20 Participants | 46 Participants | — | — | 26 Participants |
| Health System Employee Type Physicians & Advanced Practice Providers | 8 Participants | 16 Participants | — | — | 8 Participants |
| Health System Employee Type Senior Management | 2 Participants | 4 Participants | — | — | 2 Participants |
| Health System Employee Type Social Support Services | 6 Participants | 17 Participants | — | — | 11 Participants |
| Health System Employee Type Trades & Food Service | 2 Participants | 3 Participants | — | — | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 2 Participants | 2 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 7 Participants | 3 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 4 Participants | 2 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 5 Participants | 20 Participants | 4 Participants | 4 Participants | 7 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 2 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 10 Participants | 1 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) White | 157 Participants | 621 Participants | 153 Participants | 156 Participants | 155 Participants |
| Region of Enrollment United States | 167 participants | 666 participants | 166 participants | 165 participants | 168 participants |
| Sex: Female, Male Female | 150 Participants | 551 Participants | 130 Participants | 131 Participants | 140 Participants |
| Sex: Female, Male Male | 17 Participants | 115 Participants | 36 Participants | 34 Participants | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 166 | 0 / 165 | 1 / 168 | 0 / 167 |
| other Total, other adverse events | 0 / 166 | 0 / 165 | 0 / 168 | 0 / 167 |
| serious Total, serious adverse events | 0 / 166 | 0 / 165 | 0 / 168 | 0 / 167 |
Outcome results
Primary
Loneliness as Measured by the National Institutes of Health (NIH) Toolbox Social Relationship Scale for Loneliness
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.
Time frame: Baseline and 6 Months
Population: Intention to treat population - all participants who were randomized and consented.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patients - CC | Loneliness as Measured by the National Institutes of Health (NIH) Toolbox Social Relationship Scale for Loneliness | Baseline Loneliness | 64.4 T-score | Standard Deviation 9.9 |
| Patients - CC | Loneliness as Measured by the National Institutes of Health (NIH) Toolbox Social Relationship Scale for Loneliness | Follow-up Loneliness (6 months) | 61.9 T-score | Standard Deviation 10.7 |
| Patients - CC+ | Loneliness as Measured by the National Institutes of Health (NIH) Toolbox Social Relationship Scale for Loneliness | Follow-up Loneliness (6 months) | 60.8 T-score | Standard Deviation 10.3 |
| Patients - CC+ | Loneliness as Measured by the National Institutes of Health (NIH) Toolbox Social Relationship Scale for Loneliness | Baseline Loneliness | 64.4 T-score | Standard Deviation 10.3 |
| Healthcare Providers/Staff - CC | Loneliness as Measured by the National Institutes of Health (NIH) Toolbox Social Relationship Scale for Loneliness | Baseline Loneliness | 62.6 T-score | Standard Deviation 9.3 |
| Healthcare Providers/Staff - CC | Loneliness as Measured by the National Institutes of Health (NIH) Toolbox Social Relationship Scale for Loneliness | Follow-up Loneliness (6 months) | 61.2 T-score | Standard Deviation 11 |
| Healthcare Providers/Staff - CC+ | Loneliness as Measured by the National Institutes of Health (NIH) Toolbox Social Relationship Scale for Loneliness | Baseline Loneliness | 62.5 T-score | Standard Deviation 9.5 |
| Healthcare Providers/Staff - CC+ | Loneliness as Measured by the National Institutes of Health (NIH) Toolbox Social Relationship Scale for Loneliness | Follow-up Loneliness (6 months) | 61.3 T-score | Standard Deviation 11.1 |
Comparison: Difference in loneliness among patients by intervention arm at follow-up (6 months).p-value: 0.3195% CI: [-3, 1]Regression, Linear
Comparison: Difference in loneliness among healthcare providers/staff by intervention arm at follow-up (6 months).p-value: 0.8395% CI: [-1.8, 2.2]Regression, Linear
Secondary
Anxiety as Measured by the Generalized Anxiety Disorder 7 Item Scale (GAD-7)
Symptoms of anxiety will be assessed using the GAD-7, a brief self-report scale frequently used in the identification of Generalized Anxiety Disorder. The tool is composed of seven items, which are rated 0-3 to generate a score from 0-21. Higher scores indicate a greater severity of generalized anxiety symptoms. Scores of 11 and higher indicate moderate to high anxiety.
Time frame: Baseline and 6 Months
Population: The Intention to Treat population includes data for all participants who were randomized, completed study enrollment, and completed the baseline survey.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patients - CC | Anxiety as Measured by the Generalized Anxiety Disorder 7 Item Scale (GAD-7) | Follow-up GAD-7 (6 months) | 7.9 score on a scale | Standard Deviation 5.6 |
| Patients - CC | Anxiety as Measured by the Generalized Anxiety Disorder 7 Item Scale (GAD-7) | Baseline GAD-7 | 9.3 score on a scale | Standard Deviation 5.3 |
| Patients - CC+ | Anxiety as Measured by the Generalized Anxiety Disorder 7 Item Scale (GAD-7) | Baseline GAD-7 | 8.8 score on a scale | Standard Deviation 5.3 |
| Patients - CC+ | Anxiety as Measured by the Generalized Anxiety Disorder 7 Item Scale (GAD-7) | Follow-up GAD-7 (6 months) | 7.3 score on a scale | Standard Deviation 5 |
| Healthcare Providers/Staff - CC | Anxiety as Measured by the Generalized Anxiety Disorder 7 Item Scale (GAD-7) | Follow-up GAD-7 (6 months) | 6.8 score on a scale | Standard Deviation 4.7 |
| Healthcare Providers/Staff - CC | Anxiety as Measured by the Generalized Anxiety Disorder 7 Item Scale (GAD-7) | Baseline GAD-7 | 7.8 score on a scale | Standard Deviation 4.4 |
| Healthcare Providers/Staff - CC+ | Anxiety as Measured by the Generalized Anxiety Disorder 7 Item Scale (GAD-7) | Follow-up GAD-7 (6 months) | 8.2 score on a scale | Standard Deviation 5.1 |
| Healthcare Providers/Staff - CC+ | Anxiety as Measured by the Generalized Anxiety Disorder 7 Item Scale (GAD-7) | Baseline GAD-7 | 8.4 score on a scale | Standard Deviation 5 |
Comparison: Difference in anxiety (GAD-7) among patients by intervention arm at follow-up (6 months).p-value: 0.5495% CI: [-1.3, 0.7]Regression, Linear
Comparison: Difference in anxiety (GAD-7) among healthcare providers/staff by intervention arm at follow-up (6 months).p-value: 0.0495% CI: [0.1, 2]Regression, Linear
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
The National Institute of Health (NIH) Toolbox Self-Efficacy Scales Perceived Stress measure is a validated tool to measure the stress and coping resources of an individual. The measure is comprised of ten items which are scored and granted a t-score specific to adult or adolescent participants. Higher t-scores are indicative of higher levels of stress. 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 60.5 or more for adults or 60.8 or more in adolescents indicates moderate to high levels of stress.
Time frame: Baseline and 6 Months
Population: The Intention to Treat population includes data for all participants who were randomized, completed study enrollment, and completed the baseline survey.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patients - CC | 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 Perceived Stress | 60.7 T-score | Standard Deviation 8.7 |
| Patients - CC | Change From Baseline in Psychological Stress as Measured by the National Institutes of Health (NIH) Toolbox Stress and Self-Efficacy Scales Perceived Stress Measure | Change in Perceived Stress from Baseline to 6 months | -4.2 T-score | Standard Deviation 9.3 |
| Patients - CC | Change From Baseline in Psychological Stress as Measured by the National Institutes of Health (NIH) Toolbox Stress and Self-Efficacy Scales Perceived Stress Measure | Follow-up Perceived Stress (6 months) | 56.5 T-score | Standard Deviation 10.7 |
| Patients - CC+ | 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 Perceived Stress | 59.6 T-score | Standard Deviation 8.6 |
| Patients - CC+ | Change From Baseline in Psychological Stress as Measured by the National Institutes of Health (NIH) Toolbox Stress and Self-Efficacy Scales Perceived Stress Measure | Change in Perceived Stress from Baseline to 6 months | -4.4 T-score | Standard Deviation 8 |
| Patients - CC+ | Change From Baseline in Psychological Stress as Measured by the National Institutes of Health (NIH) Toolbox Stress and Self-Efficacy Scales Perceived Stress Measure | Follow-up Perceived Stress (6 months) | 55.3 T-score | Standard Deviation 10.1 |
| Healthcare Providers/Staff - CC | Change From Baseline in Psychological Stress as Measured by the National Institutes of Health (NIH) Toolbox Stress and Self-Efficacy Scales Perceived Stress Measure | Follow-up Perceived Stress (6 months) | 55.1 T-score | Standard Deviation 9.2 |
| Healthcare Providers/Staff - CC | 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 Perceived Stress | 58.5 T-score | Standard Deviation 7.3 |
| Healthcare Providers/Staff - CC | Change From Baseline in Psychological Stress as Measured by the National Institutes of Health (NIH) Toolbox Stress and Self-Efficacy Scales Perceived Stress Measure | Change in Perceived Stress from Baseline to 6 months | -3.3 T-score | Standard Deviation 10.3 |
| Healthcare Providers/Staff - CC+ | 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 Perceived Stress | 59.5 T-score | Standard Deviation 7.7 |
| Healthcare Providers/Staff - CC+ | Change From Baseline in Psychological Stress as Measured by the National Institutes of Health (NIH) Toolbox Stress and Self-Efficacy Scales Perceived Stress Measure | Change in Perceived Stress from Baseline to 6 months | -1.9 T-score | Standard Deviation 9.9 |
| Healthcare Providers/Staff - CC+ | Change From Baseline in Psychological Stress as Measured by the National Institutes of Health (NIH) Toolbox Stress and Self-Efficacy Scales Perceived Stress Measure | Follow-up Perceived Stress (6 months) | 57.6 T-score | Standard Deviation 9.6 |
Comparison: Change in stress from baseline to 6 months among patients.p-value: 0.8495% CI: [-2.1, 1.7]Regression, Linear
Comparison: Change in stress from baseline to 6 months among healthcare providers/staff.p-value: 0.1895% CI: [-0.7, 3.7]Regression, Linear
Secondary
Depression as Measured by the Patient Health Questionnaire (PHQ-9)
The PHQ-9 is a widely used and validated tool to screen for depression in primary care and other non-psychiatric settings. The tool is composed of 9 questions each with a response of 0-3 which generate a score from 0-27 with higher scores indicating a greater degree of depression. Scores are categorized in the following manner: a score of 5-9 is considered minimal depression, 10-14 is considered mild major, 15-19 is moderate major, and ≥20 is severe major.
Time frame: Baseline and 6 Months
Population: The Intention to Treat population includes data for all participants who were randomized, completed study enrollment, and completed the baseline survey.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patients - CC | Depression as Measured by the Patient Health Questionnaire (PHQ-9) | Baseline PHQ-9 | 10.5 score on a scale | Standard Deviation 6.1 |
| Patients - CC | Depression as Measured by the Patient Health Questionnaire (PHQ-9) | Follow-up PHQ-9 (6 months) | 8.6 score on a scale | Standard Deviation 6.2 |
| Patients - CC+ | Depression as Measured by the Patient Health Questionnaire (PHQ-9) | Follow-up PHQ-9 (6 months) | 7.9 score on a scale | Standard Deviation 5.8 |
| Patients - CC+ | Depression as Measured by the Patient Health Questionnaire (PHQ-9) | Baseline PHQ-9 | 10.0 score on a scale | Standard Deviation 6 |
| Healthcare Providers/Staff - CC | Depression as Measured by the Patient Health Questionnaire (PHQ-9) | Baseline PHQ-9 | 8.4 score on a scale | Standard Deviation 5 |
| Healthcare Providers/Staff - CC | Depression as Measured by the Patient Health Questionnaire (PHQ-9) | Follow-up PHQ-9 (6 months) | 7.7 score on a scale | Standard Deviation 5.1 |
| Healthcare Providers/Staff - CC+ | Depression as Measured by the Patient Health Questionnaire (PHQ-9) | Baseline PHQ-9 | 8.6 score on a scale | Standard Deviation 5.4 |
| Healthcare Providers/Staff - CC+ | Depression as Measured by the Patient Health Questionnaire (PHQ-9) | Follow-up PHQ-9 (6 months) | 8.1 score on a scale | Standard Deviation 5.4 |
Comparison: Difference in depression (PHQ-9) among patients by intervention arm at follow-up (6 months).p-value: 0.4595% CI: [-1.5, 0.7]Regression, Linear
Comparison: Difference in depression (PHQ-9) among healthcare providers/staff by intervention arm at follow-up (6 months).p-value: 0.5195% CI: [-0.7, 1.3]Regression, Linear
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
The questions are adapted from the Youth Risk Behavior Survey and will contain additional questions to measure self-reported changes in alcohol or illicit-drug use since the beginning of the COVID-19 pandemic.
Time frame: Baseline and 6 Months
Population: The Intention to Treat population includes data for all participants who were randomized, completed study enrollment, and completed the baseline survey.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Patients - CC | 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 | Increased tobacco use at follow-up (6 months) | 23 Participants |
| Patients - CC | 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 | Increased alcohol use at follow-up (6 months) | 42 Participants |
| Patients - CC | 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 | Increased illicit drug use at follow-up (6 months) | 7 Participants |
| Patients - CC | 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 | Increased marijuana/cannabis use at follow-up (6 months) | 15 Participants |
| Patients - CC+ | 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 | Increased alcohol use at follow-up (6 months) | 38 Participants |
| Patients - CC+ | 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 | Increased illicit drug use at follow-up (6 months) | 3 Participants |
| Patients - CC+ | 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 | Increased marijuana/cannabis use at follow-up (6 months) | 19 Participants |
| Patients - CC+ | 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 | Increased tobacco use at follow-up (6 months) | 13 Participants |
| Healthcare Providers/Staff - CC | 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 | Increased tobacco use at follow-up (6 months) | 16 Participants |
| Healthcare Providers/Staff - CC | 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 | Increased illicit drug use at follow-up (6 months) | 3 Participants |
| Healthcare Providers/Staff - CC | 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 | Increased marijuana/cannabis use at follow-up (6 months) | 17 Participants |
| Healthcare Providers/Staff - CC | 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 | Increased alcohol use at follow-up (6 months) | 52 Participants |
| Healthcare Providers/Staff - CC+ | 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 | Increased illicit drug use at follow-up (6 months) | 2 Participants |
| Healthcare Providers/Staff - CC+ | 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 | Increased tobacco use at follow-up (6 months) | 6 Participants |
| Healthcare Providers/Staff - CC+ | 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 | Increased alcohol use at follow-up (6 months) | 55 Participants |
| Healthcare Providers/Staff - CC+ | 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 | Increased marijuana/cannabis use at follow-up (6 months) | 14 Participants |
Comparison: Number of participants with increased tobacco use among patients randomized to CC+ vs CCp-value: 0.1295% CI: [-12.5, 1.4]GLM
Comparison: Number of participants with increased tobacco use among healthcare providers/staff randomized to CC+ vs CCp-value: 0.0395% CI: [-11.5, -0.7]GLM
Comparison: Number of participants with increased alcohol use among patients randomized to CC+ vs CCp-value: 0.8395% CI: [-10.7, 8.5]GLM
Comparison: Number of participants with increased alcohol use among healthcare providers/staff randomized to CC+ vs CCp-value: 0.6795% CI: [-8, 12.5]GLM
Comparison: Number of participants with increased marijuana/cannabis use among patients randomized to CC+ vs CCp-value: 0.4295% CI: [-4.1, 9.9]GLM
Comparison: Number of participants with increased marijuana/cannabis use among healthcare providers/staff randomized to CC+ vs CCp-value: 0.5395% CI: [-8.7, 4.5]GLM
Comparison: Number of participants with increased illicit drug use among patients randomized to CC+ vs CCp-value: 0.295% CI: [-6.3, 1.4]GLM
Comparison: Number of participants with increased illicit drug use among healthcare providers/staff randomized to CC+ vs CCp-value: 0.6295% CI: [-3.4, 2]GLM
Secondary
Number of Participants Reporting Suicide Attempts as Measured by the Columbia Suicide Severity Rating Scale & Completed Suicide
Three elements of the full version of the Columbia Suicide Severity Rating Scale (C-SSRS) (lifetime-recent (baseline) and since last visit (6 months)) were complied to create a Suicide Attempts Survey. These measured self-reported aborted or self-interrupted suicide attempts, interrupted suicide attempts, and actual suicide attempts. Non-lethal self-harm and lethal means used for attempts or completions were also collected. These elements were not included in the C-SSRS score but were compared across the intervention groups. Medical records were used to measure suicide completion.
Time frame: Baseline and 6 Months
Population: The Intention to Treat population includes data for all participants who were randomized, completed study enrollment, and completed the baseline survey.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Patients - CC | Number of Participants Reporting Suicide Attempts as Measured by the Columbia Suicide Severity Rating Scale & Completed Suicide | Death by suicide | 0 Participants |
| Patients - CC | Number of Participants Reporting Suicide Attempts as Measured by the Columbia Suicide Severity Rating Scale & Completed Suicide | Interrupted/aborted suicide | 0 Participants |
| Patients - CC | Number of Participants Reporting Suicide Attempts as Measured by the Columbia Suicide Severity Rating Scale & Completed Suicide | Attempted suicide | 0 Participants |
| Patients - CC+ | Number of Participants Reporting Suicide Attempts as Measured by the Columbia Suicide Severity Rating Scale & Completed Suicide | Death by suicide | 0 Participants |
| Patients - CC+ | Number of Participants Reporting Suicide Attempts as Measured by the Columbia Suicide Severity Rating Scale & Completed Suicide | Interrupted/aborted suicide | 1 Participants |
| Patients - CC+ | Number of Participants Reporting Suicide Attempts as Measured by the Columbia Suicide Severity Rating Scale & Completed Suicide | Attempted suicide | 0 Participants |
| Healthcare Providers/Staff - CC | Number of Participants Reporting Suicide Attempts as Measured by the Columbia Suicide Severity Rating Scale & Completed Suicide | Attempted suicide | 2 Participants |
| Healthcare Providers/Staff - CC | Number of Participants Reporting Suicide Attempts as Measured by the Columbia Suicide Severity Rating Scale & Completed Suicide | Death by suicide | 1 Participants |
| Healthcare Providers/Staff - CC | Number of Participants Reporting Suicide Attempts as Measured by the Columbia Suicide Severity Rating Scale & Completed Suicide | Interrupted/aborted suicide | 3 Participants |
| Healthcare Providers/Staff - CC+ | Number of Participants Reporting Suicide Attempts as Measured by the Columbia Suicide Severity Rating Scale & Completed Suicide | Death by suicide | 0 Participants |
| Healthcare Providers/Staff - CC+ | Number of Participants Reporting Suicide Attempts as Measured by the Columbia Suicide Severity Rating Scale & Completed Suicide | Interrupted/aborted suicide | 3 Participants |
| Healthcare Providers/Staff - CC+ | Number of Participants Reporting Suicide Attempts as Measured by the Columbia Suicide Severity Rating Scale & Completed Suicide | Attempted suicide | 0 Participants |
Secondary
Number of Participants Who Attended Mental Healthcare Appointments: Self-Report
Participant engagement in outpatient mental health services will be measured as a dichotomous variable through self-report.
Time frame: 6 Months
Population: The Intention to Treat population includes data for all participants who were randomized, completed study enrollment, and completed the baseline survey.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Patients - CC | Number of Participants Who Attended Mental Healthcare Appointments: Self-Report | 119 Participants |
| Patients - CC+ | Number of Participants Who Attended Mental Healthcare Appointments: Self-Report | 105 Participants |
| Healthcare Providers/Staff - CC | Number of Participants Who Attended Mental Healthcare Appointments: Self-Report | 124 Participants |
| Healthcare Providers/Staff - CC+ | Number of Participants Who Attended Mental Healthcare Appointments: Self-Report | 123 Participants |
Comparison: Difference in proportion of patients attending mental healthcare appointments by intervention arm at follow-up (6 months).p-value: 0.4195% CI: [-15.4, 6.3]GLM
Comparison: Difference in proportion of healthcare providers/staff attending mental healthcare appointments by intervention arm at follow-up (6 months).p-value: 0.3195% CI: [-5.2, 16.2]GLM
Secondary
Perceived Burdensomeness & Thwarted Belongingness as Measured by the Interpersonal Needs Questionnaire (INQ15)
The Interpersonal Needs Questionnaire (INQ) was developed from the Interpersonal Theory of Suicide and the 15-item version (INQ15) is a validated tool to measure both perceived burdensomeness (PB) (6 items, scores range from 6 to 42) and thwarted belongingness (TB) (9 items; scores range from 9 to 63). Individuals provide a self-report response to each item ranging from 1 (Not at all true for me) to 7 (Very true for me). The appropriate items are reverse coded, and items are summed to calculate the TB and PB subscale scores with higher scores indicating greater TB and PB. Clinical Cutoff scores predicting desire for death are 35 or greater for TB and 19 or greater for PB. Clinical cutoff scores predicting desire for suicide are 50 or greater for TB and 30 or greater for PB.
Time frame: Baseline and 6 Months
Population: The Intention to Treat population includes data for all participants who were randomized, completed study enrollment, and completed the baseline survey.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patients - CC | Perceived Burdensomeness & Thwarted Belongingness as Measured by the Interpersonal Needs Questionnaire (INQ15) | Baseline INQ Perceived Burdensomeness | 10.1 score on a scale | Standard Deviation 6.7 |
| Patients - CC | Perceived Burdensomeness & Thwarted Belongingness as Measured by the Interpersonal Needs Questionnaire (INQ15) | Follow-up INQ Perceived Burdensomeness (6 months) | 9.6 score on a scale | Standard Deviation 6.8 |
| Patients - CC | Perceived Burdensomeness & Thwarted Belongingness as Measured by the Interpersonal Needs Questionnaire (INQ15) | Baseline INQ Thwarted Belongingness | 31.1 score on a scale | Standard Deviation 11.1 |
| Patients - CC | Perceived Burdensomeness & Thwarted Belongingness as Measured by the Interpersonal Needs Questionnaire (INQ15) | Follow-up INQ Thwarted Belongingness (6 months) | 29.3 score on a scale | Standard Deviation 12.2 |
| Patients - CC+ | Perceived Burdensomeness & Thwarted Belongingness as Measured by the Interpersonal Needs Questionnaire (INQ15) | Follow-up INQ Perceived Burdensomeness (6 months) | 9.5 score on a scale | Standard Deviation 6.7 |
| Patients - CC+ | Perceived Burdensomeness & Thwarted Belongingness as Measured by the Interpersonal Needs Questionnaire (INQ15) | Baseline INQ Thwarted Belongingness | 30.3 score on a scale | Standard Deviation 11.4 |
| Patients - CC+ | Perceived Burdensomeness & Thwarted Belongingness as Measured by the Interpersonal Needs Questionnaire (INQ15) | Follow-up INQ Thwarted Belongingness (6 months) | 27.6 score on a scale | Standard Deviation 12.3 |
| Patients - CC+ | Perceived Burdensomeness & Thwarted Belongingness as Measured by the Interpersonal Needs Questionnaire (INQ15) | Baseline INQ Perceived Burdensomeness | 9.2 score on a scale | Standard Deviation 5.4 |
| Healthcare Providers/Staff - CC | Perceived Burdensomeness & Thwarted Belongingness as Measured by the Interpersonal Needs Questionnaire (INQ15) | Baseline INQ Thwarted Belongingness | 31.4 score on a scale | Standard Deviation 10 |
| Healthcare Providers/Staff - CC | Perceived Burdensomeness & Thwarted Belongingness as Measured by the Interpersonal Needs Questionnaire (INQ15) | Follow-up INQ Perceived Burdensomeness (6 months) | 8.4 score on a scale | Standard Deviation 5.1 |
| Healthcare Providers/Staff - CC | Perceived Burdensomeness & Thwarted Belongingness as Measured by the Interpersonal Needs Questionnaire (INQ15) | Follow-up INQ Thwarted Belongingness (6 months) | 27.8 score on a scale | Standard Deviation 12.3 |
| Healthcare Providers/Staff - CC | Perceived Burdensomeness & Thwarted Belongingness as Measured by the Interpersonal Needs Questionnaire (INQ15) | Baseline INQ Perceived Burdensomeness | 7.9 score on a scale | Standard Deviation 3.6 |
| Healthcare Providers/Staff - CC+ | Perceived Burdensomeness & Thwarted Belongingness as Measured by the Interpersonal Needs Questionnaire (INQ15) | Follow-up INQ Thwarted Belongingness (6 months) | 28.6 score on a scale | Standard Deviation 12.4 |
| Healthcare Providers/Staff - CC+ | Perceived Burdensomeness & Thwarted Belongingness as Measured by the Interpersonal Needs Questionnaire (INQ15) | Follow-up INQ Perceived Burdensomeness (6 months) | 8.5 score on a scale | Standard Deviation 5.1 |
| Healthcare Providers/Staff - CC+ | Perceived Burdensomeness & Thwarted Belongingness as Measured by the Interpersonal Needs Questionnaire (INQ15) | Baseline INQ Perceived Burdensomeness | 8.0 score on a scale | Standard Deviation 4.9 |
| Healthcare Providers/Staff - CC+ | Perceived Burdensomeness & Thwarted Belongingness as Measured by the Interpersonal Needs Questionnaire (INQ15) | Baseline INQ Thwarted Belongingness | 30.4 score on a scale | Standard Deviation 11.8 |
Comparison: Difference in perceived burdensomeness (INQ15) among patients by intervention arm at follow-up (6 months).p-value: 0.3895% CI: [-0.6, 1.6]Regression, Linear
Comparison: Difference in perceived burdensomeness (INQ15) among healthcare providers/staff by intervention arm at follow-up (6 months).p-value: 0.8195% CI: [-0.8, 1]Regression, Linear
Comparison: Difference in thwarted belongingness (INQ15) among patients by intervention arm at follow-up (6 months).p-value: 0.7395% CI: [-2.6, 1.8]Regression, Linear
Comparison: Difference in thwarted belongingness (INQ15) among healthcare providers/staff by intervention arm at follow-up (6 months).p-value: 0.2495% CI: [-0.8, 3.2]Regression, Linear
Secondary
Suicidal Ideation & Behavior as Measured by the Columbia Suicide Severity Rating Scale
The Columbia Suicide Severity Rating Scale (C-SSRS) 6-item screener (self-assessment lifetime-recent (baseline) and since last visit (6 months) for Primary Care settings versions will be used). The C-SSRS is a validated tool to assess suicidality. C-SSRS score is determined based on the highest question number to which the participant responds yes. For example, a score of 5 would be assigned to a participant who responded yes to Question 5 and any or all preceding questions. Higher scores are indicative of greater risk for suicide. C-SSRS screener scores range from 0 to 6, with higher scores indicative of higher suicide risk. Scores of 3 and higher indicate moderate to high risk for suicide.
Time frame: Baseline and 6 Months
Population: The Intention to Treat population includes data for all participants who were randomized, completed study enrollment, and completed the baseline survey.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patients - CC | Suicidal Ideation & Behavior as Measured by the Columbia Suicide Severity Rating Scale | Baseline C-SSRS | 0.5 score on a scale | Standard Deviation 1.3 |
| Patients - CC | Suicidal Ideation & Behavior as Measured by the Columbia Suicide Severity Rating Scale | Follow-up C-SSRS (6 months) | 0.4 score on a scale | Standard Deviation 0.9 |
| Patients - CC+ | Suicidal Ideation & Behavior as Measured by the Columbia Suicide Severity Rating Scale | Follow-up C-SSRS (6 months) | 0.6 score on a scale | Standard Deviation 1.3 |
| Patients - CC+ | Suicidal Ideation & Behavior as Measured by the Columbia Suicide Severity Rating Scale | Baseline C-SSRS | 0.4 score on a scale | Standard Deviation 1.1 |
| Healthcare Providers/Staff - CC | Suicidal Ideation & Behavior as Measured by the Columbia Suicide Severity Rating Scale | Baseline C-SSRS | 0.3 score on a scale | Standard Deviation 0.9 |
| Healthcare Providers/Staff - CC | Suicidal Ideation & Behavior as Measured by the Columbia Suicide Severity Rating Scale | Follow-up C-SSRS (6 months) | 0.5 score on a scale | Standard Deviation 1.2 |
| Healthcare Providers/Staff - CC+ | Suicidal Ideation & Behavior as Measured by the Columbia Suicide Severity Rating Scale | Baseline C-SSRS | 0.4 score on a scale | Standard Deviation 1.1 |
| Healthcare Providers/Staff - CC+ | Suicidal Ideation & Behavior as Measured by the Columbia Suicide Severity Rating Scale | Follow-up C-SSRS (6 months) | 0.4 score on a scale | Standard Deviation 1.1 |
Comparison: Difference in suicidal ideation and behavior (C-SSRS) among patients by intervention arm at follow-up (6 months).p-value: 0.0595% CI: [0, 0.5]Regression, Linear
Comparison: Difference in suicidal ideation and behavior (C-SSRS) among healthcare providers/staff by intervention arm at follow-up (6 months).p-value: 0.295% CI: [-0.4, 0.1]Regression, Linear