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

Primary Purpose

Covid19, Mental Health

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Caring Contacts Plus Introductory Phone Call (CC+)
Caring Contacts without an introductory phone call (CC)
Sponsored by
St. Luke's Health System, Boise, Idaho
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Covid19 focused on measuring Loneliness, Anxiety, Depression, Suicidal Ideation, Social Distancing, Mental Distress, Pandemic, Caring Contacts, Healthcare Staff, Healthcare Providers, Brief Contact Intervention, Adults, Adolescents

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • St. Luke's Health System

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Caring Contacts + Introductory Phone Call (CC+)

Caring Contacts (without phone call) (CC)

Arm Description

Healthcare provider and staff participants who are randomized to both caring text messages and an introductory phone call. Adult and adolescent participants who are randomized to both caring text messages and an introductory phone call.

Healthcare provider and staff participants who are randomized to only caring text messages. Adult and adolescent patient participants who are randomized to only caring text messages.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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. The change from baseline score will be used to determine a change in suicidal ideation and behavior.
Suicide Attempts & Self-Harm as measured by the Columbia Suicide Severity Rating Scale
Three elements of the full version of the C-SSRS (lifetime-recent (baseline) and since last visit (6 months)) have been complied to create a Suicide Attempts Survey. These will measure 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 will also be collected. These elements will not be included in the C-SSRS score but will be compared across the intervention groups. Vital records will be used to measure suicide completion.
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 is a validated tool to measure both perceived burdensomeness and thwarted belongingness which are proximal causes of desire for suicide. The INQ15 asks respondents to indicate how true each is for them on a scale of 1 to 7, with 1 being "not true at all for me" and 7 being "very true for me". The ratings are compiled into a score with higher scores indicating higher levels of perceived burdensomeness and thwarted belongingness.
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.
Alcohol 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.
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.
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.
Attendance at Mental Healthcare Appointments: Self-Report
Participant engagement in outpatient mental health services will be measured as dichotomous variables through self-report.

Full Information

First Posted
January 5, 2021
Last Updated
January 12, 2022
Sponsor
St. Luke's Health System, Boise, Idaho
Collaborators
Patient-Centered Outcomes Research Institute, Idaho Suicide Prevention Hotline (Jannus, Inc.), University of Washington
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1. Study Identification

Unique Protocol Identification Number
NCT04700137
Brief Title
Mental Health Among Patients, Providers, and Staff During the COVID-19 Era
Acronym
MHAPPS
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
January 18, 2021 (Actual)
Primary Completion Date
January 6, 2022 (Actual)
Study Completion Date
January 6, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Luke's Health System, Boise, Idaho
Collaborators
Patient-Centered Outcomes Research Institute, Idaho Suicide Prevention Hotline (Jannus, Inc.), University of Washington

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19, Mental Health
Keywords
Loneliness, Anxiety, Depression, Suicidal Ideation, Social Distancing, Mental Distress, Pandemic, Caring Contacts, Healthcare Staff, Healthcare Providers, Brief Contact Intervention, Adults, Adolescents

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
666 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Caring Contacts + Introductory Phone Call (CC+)
Arm Type
Active Comparator
Arm Description
Healthcare provider and staff participants who are randomized to both caring text messages and an introductory phone call. Adult and adolescent participants who are randomized to both caring text messages and an introductory phone call.
Arm Title
Caring Contacts (without phone call) (CC)
Arm Type
Active Comparator
Arm Description
Healthcare provider and staff participants who are randomized to only caring text messages. Adult and adolescent patient participants who are randomized to only caring text messages.
Intervention Type
Other
Intervention Name(s)
Caring Contacts Plus Introductory Phone Call (CC+)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Caring Contacts without an introductory phone call (CC)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Loneliness as measured by the National Institutes of Health (NIH) Toolbox Social Relationship Scale for Loneliness
Description
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.
Time Frame
Baseline and 6 Months
Secondary Outcome Measure Information:
Title
Suicidal Ideation & Behavior as measured by the Columbia Suicide Severity Rating Scale
Description
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. The change from baseline score will be used to determine a change in suicidal ideation and behavior.
Time Frame
Baseline and 6 Months
Title
Suicide Attempts & Self-Harm as measured by the Columbia Suicide Severity Rating Scale
Description
Three elements of the full version of the C-SSRS (lifetime-recent (baseline) and since last visit (6 months)) have been complied to create a Suicide Attempts Survey. These will measure 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 will also be collected. These elements will not be included in the C-SSRS score but will be compared across the intervention groups. Vital records will be used to measure suicide completion.
Time Frame
Baseline and 6 Months
Title
Perceived Burdensomeness & Thwarted Belongingness as measured by the Interpersonal Needs Questionnaire (INQ15)
Description
The Interpersonal Needs Questionnaire (INQ) was developed from the Interpersonal Theory of Suicide and the 15-item version is a validated tool to measure both perceived burdensomeness and thwarted belongingness which are proximal causes of desire for suicide. The INQ15 asks respondents to indicate how true each is for them on a scale of 1 to 7, with 1 being "not true at all for me" and 7 being "very true for me". The ratings are compiled into a score with higher scores indicating higher levels of perceived burdensomeness and thwarted belongingness.
Time Frame
Baseline and 6 Months
Title
Psychological Stress as measured by the National Institutes of Health (NIH) Toolbox Stress and Self-Efficacy Scales Perceived Stress measure
Description
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.
Time Frame
Baseline and 6 Months
Title
Alcohol and Illicit Drug Use as measured by questions adapted from Youth Risk Behavior Survey and related to COVID-19
Description
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
Title
Depression as measured by the Patient Health Questionnaire (PHQ-9)
Description
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
Title
Anxiety as measured by the Generalized Anxiety Disorder 7 Item Scale (GAD-7)
Description
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.
Time Frame
Baseline and 6 Months
Title
Attendance at Mental Healthcare Appointments: Self-Report
Description
Participant engagement in outpatient mental health services will be measured as dichotomous variables through self-report.
Time Frame
6 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anna K Radin, DrPH, MPH
Organizational Affiliation
St. Luke's Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Luke's Health System
City
Boise
State/Province
Idaho
ZIP/Postal Code
83712
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data from this trial may be requested from other researchers 5 years after the completion of the primary endpoint by contacting the PIs.
IPD Sharing Time Frame
5 years following the completion of the primary endpoint
IPD Sharing Access Criteria
Data from this trial may be requested by other researchers 5 years after the completion of the primary endpoint by contacting the PI. The PI will ensure all mechanisms used to share data will include proper plans and safeguards for the protection of privacy, confidentiality, and security for data dissemination and reuse (e.g., all data will be thoroughly de-identified and will not be traceable to a specific study participant).

Learn more about this trial

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

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