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

NCT04700137 | Completed Results DMC

• 2 other identifiers: 20-0052PCORI HIS-2018C3-14695
• Study Type: interventional
• Target: 666
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (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.

  Baseline and 6 Months

Secondary Outcomes (8)

• Suicidal Ideation & Behavior as Measured by the Columbia Suicide Severity Rating Scale

  Baseline and 6 Months

• Depression as Measured by the Patient Health Questionnaire (PHQ-9)

  Baseline and 6 Months

• Anxiety as Measured by the Generalized Anxiety Disorder 7 Item Scale (GAD-7)

  Baseline and 6 Months

• Change From Baseline in Psychological Stress as Measured by the National Institutes of Health (NIH) Toolbox Stress and Self-Efficacy Scales Perceived Stress Measure

  Baseline and 6 Months

• Perceived Burdensomeness & Thwarted Belongingness as Measured by the Interpersonal Needs Questionnaire (INQ15)

  Baseline and 6 Months

Study Arms (2)

Caring Contacts + Introductory Phone Call (CC+)

ACTIVE COMPARATOR

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.

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

Caring Contacts (without phone call) (CC)

ACTIVE COMPARATOR

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.

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

Interventions

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 + Introductory Phone Call (CC+)

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.

Caring Contacts (without phone call) (CC)

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Aim 1:
• Provider or Employee at St. Luke's Health System
• Adults ≥ 18 years of age
• Proficient in spoken and written English language
• 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:
• 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

You may not qualify if:

• Aim 1:
• Individuals who are unable or unwilling to provide informed consent to participate
• Individuals who are study staff for this study or the SPARC Trial
• 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:
• 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
• 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).

Sponsors & Collaborators

• St. Luke's Health System, Boise, Idaho: lead
• Patient-Centered Outcomes Research Institute: collaborator
• Idaho Crisis & Suicide Hotline: collaborator
• University of Washington: collaborator

Study Sites (1)

St. Luke's Health System

Boise, Idaho, 83712, United States

Location

Related Publications (1)

• 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.

  PMID: 36963515 DERIVED

MeSH Terms

Conditions

COVID-19; Psychological Well-Being; Anxiety Disorders; Depression; Suicidal Ideation

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Personal Satisfaction; Behavior; Mental Disorders; Behavioral Symptoms; Suicide; Self-Injurious Behavior

Results Point of Contact

• Title: Dr. Anna K. Radin
• Organization: St. Luke's Health System

radina@slhs.org

208/381-8460

Study Officials

• Anna K Radin, DrPH, MPH

  St. Luke's Health System

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Applied Research Scientist

Study Record Dates

• First Submitted: January 5, 2021
• First Posted: January 7, 2021
• Study Start: January 18, 2021
• Primary Completion: January 6, 2022
• Study Completion: January 6, 2022
• Last Updated: January 25, 2024
• Results First Posted: January 25, 2024

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 5 years following the completion of the primary endpoint
• 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).

Locations

US (1)