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Covid19MHAPPSNCT04700137

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

A study testing Caring Contacts Plus Introductory Phone Call (CC+) and Caring Contacts without an introductory phone call (CC) in people with Covid19 and Mental Health, run by St. Luke's Health System, Boise, Idaho at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
Covid19, Mental Health
What is being tested?
Caring Contacts Plus Introductory Phone Call (CC+) and Caring Contacts without an introductory phone call (CC)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
666 participants
Where
1 siteUnited States
Study dates
18 Jan 2021to 6 Jan 2022
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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
Show all 29Show fewer
  • 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

Who cannot join

  • 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.
Show all 16Show fewer
  • 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).

Trial locations and contacts

1 site in 1 country.

United States1 site
  • St. Luke's Health System

    Boise, Idaho, 83712

Other trials in United States

About this study

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

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:

Read more

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.

Read the 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.

Being tested
Caring Contacts Plus Introductory Phone Call (CC+), Caring Contacts without an introductory phone call (CC)
Keywords
Loneliness, Anxiety, Depression, Suicidal Ideation, Social Distancing, Mental Distress, Pandemic, Caring Contacts, Healthcare Staff, Healthcare Providers, Brief Contact Intervention, Adults, Adolescents
Medical subject headings
COVID-19, Psychological Well-Being, Anxiety Disorders, Depression, Suicidal Ideation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Caring Contacts Plus Introductory Phone Call (CC+)Other

    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.

  • Caring Contacts without an introductory phone call (CC)Other

    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.

Study groups in NCT04700137
Study groupRoleWhat they receive
Caring Contacts + Introductory Phone Call (CC+)Active comparatorHealthcare 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.
Receives: Other: Caring Contacts Plus Introductory Phone Call (CC+)
Caring Contacts (without phone call) (CC)Active comparatorHealthcare 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.
Receives: Other: Caring Contacts without an introductory phone call (CC)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline and 6 Months

Secondary outcomes (8)
  1. 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.

    Measured: Baseline and 6 Months

  2. 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.

    Measured: Baseline and 6 Months

  3. 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.

    Measured: Baseline and 6 Months

  4. 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.

    Measured: Baseline and 6 Months

  5. 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.

    Measured: Baseline and 6 Months

  6. 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.

    Measured: Baseline and 6 Months

  7. 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.

    Measured: Baseline and 6 Months

  8. 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.

    Measured: 6 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jan 2021
  2. Study start18 Jan 2021
  3. Primary completion6 Jan 2022
  4. Study completion6 Jan 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
666 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04700137
Sponsor's protocol ID
20-0052
Other IDs
PCORI HIS-2018C3-14695
Acronym
MHAPPS
Status last verified
May 2023
First submitted
5 Jan 2021
Last updated
25 Jan 2024
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Data from this trial may be requested from other researchers 5 years after the completion of the primary endpoint by contacting the PIs.

Publications

  • Radin AK, Shaw J, Brown SP, Torres J, Harper M, Flint H, Fouts T, McCue E, Skeie A, Pena C, Youell J, Doty-Jones A, Wilson J, Flinn L, Austin G, Chan KCG, Zheng Z, Fruhbauerova M, Walton M, Kerbrat A, Comtois KA. Comparative effectiveness of two versions of a caring contacts intervention in healthcare providers, staff, and patients for reducing loneliness and mental distress: A randomized controlled trial. J Affect Disord. 2023 Jun 15;331:442-451. doi: 10.1016/j.jad.2023.03.029. Epub 2023 Mar 22.

    PubMed 36963515

Questions about this trial

What is this clinical trial studying?

A study testing Caring Contacts Plus Introductory Phone Call (CC+) and Caring Contacts without an introductory phone call (CC) in people with Covid19 and Mental Health, run by St. Luke's Health System, Boise, Idaho at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 29 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Loneliness as Measured by the National Institutes of Health (NIH) Toolbox Social Relationship Scale for Loneliness (time frame: Baseline and 6 Months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04700137, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2024.

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