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Mitigating Mental and Social Health Outcomes of COVID-19: A Counseling Approach

Primary Purpose

Social Determinants of Health, Mental Health Issue, COVID-19

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Individual Counseling
Group Counseling
Resources
Sponsored by
New Mexico State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Social Determinants of Health

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: at least 18 years of age received a COVID-19 diagnosis within the last year reports experiencing economic, social, educational, healthcare, and/or environmentally related challenges due to their COVID-19 diagnosis is not currently receiving mental health counseling services resides in one of the following counties in Southern New Mexico (NM): Hidalgo, Grant, Catron, Luna, Doña Ana, Sierra, or Socorro County has access to the internet has not experienced active suicidal or homicidal ideation or active psychosis in the last six months Exclusion Criteria: is not at least 18 years of age has not received a COVID-19 diagnosis within the last year does not report experiencing economic, social, educational, healthcare, and/or environmentally related challenges due to their COVID-19 diagnosis is currently receiving mental health counseling services does not reside in one of the following counties in Southern NM: Hidalgo, Grant, Catron, Luna, Doña Ana, Sierra, or Socorro County does not have access to the internet has experienced active suicidal or homicidal ideation or active psychosis in the last six months

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Participants

    Arm Description

    All participants will be asked to complete the following: participate in 12 individual mental health counseling sessions participate in 3 group counseling sessions receive information on community resources related to their social and mental health needs/challenges

    Outcomes

    Primary Outcome Measures

    Social and Mental Health Outcomes of COVID-19
    Semi-structured, audio recorded interview to gather information on the SDOH and mental health impacts of COVID-19
    Social determinants of health challenges
    Self-report measure of SDOH needs through the WellRx (Page-Reeves et al., 2016)
    Changes in mental health
    Self-report quantitative measures of depression, anxiety, and wellness
    Program Feasibility/Impact
    Qualitative data collected via semi-structured exit interviews of participants and their counselors

    Secondary Outcome Measures

    Full Information

    First Posted
    February 17, 2023
    Last Updated
    February 20, 2023
    Sponsor
    New Mexico State University
    Collaborators
    National Institutes of Health (NIH)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05739526
    Brief Title
    Mitigating Mental and Social Health Outcomes of COVID-19: A Counseling Approach
    Official Title
    Mitigating Mental and Social Health Outcomes of COVID-19: A Counseling Approach
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 2023 (Anticipated)
    Primary Completion Date
    May 2024 (Anticipated)
    Study Completion Date
    July 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    New Mexico State University
    Collaborators
    National Institutes of Health (NIH)

    4. Oversight

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

    5. Study Description

    Brief Summary
    The goal of this clinical trial is to develop a comprehensive mental health counseling program purposed to address the social determinant of health impacts of the coronavirus disease of 2019 (COVID-19). The main questions the investigators aim to answer are: 1) What are the mental and social determinant of health impacts of a COVID-19 diagnosis, and 2) What are the impacts of a counseling program implemented to address those impacts? Participants will participate in individual interviews, attend individual and group counseling, and be provided resources related to their social determinants of health needs.
    Detailed Description
    The social determinants of health (SDOH) are an important social justice issue affecting various quality of life outcomes (e.g., physical and mental health). COVID-19 has disproportionately affected the SDOH of underserved and minority communities, including those in Southern New Mexico (NM). However, there is a lack of research on specifically how COVID-19 has affected individuals' SDOH, inhibiting prevention and response from mental health professionals and their interprofessional collaborators. Counselor education researchers have also not yet conducted outcome-based studies in this area. This research will support the development of a comprehensive, SDOH-focused mental health counseling program aimed to assess for and address the SDOH impacts of COVID-19 for individuals in Southern NM. This research will include in-depth assessment of participants' SDOH needs pertinent to COVID-19. Participants will be provided resources and referrals specific to those needs, and engage in individual and group mental health counseling services aimed to mitigate the adverse mental and social health outcomes of COVID-19. Thus, this research should provide understanding of (1) the SDOH impacts of COVID-19, (2) feasibility of a mental health counseling program purposed to address such needs, and (3) the mental health and SDOH-related impacts of such a counseling program.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Social Determinants of Health, Mental Health Issue, COVID-19

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Participants
    Arm Type
    Experimental
    Arm Description
    All participants will be asked to complete the following: participate in 12 individual mental health counseling sessions participate in 3 group counseling sessions receive information on community resources related to their social and mental health needs/challenges
    Intervention Type
    Other
    Intervention Name(s)
    Individual Counseling
    Intervention Description
    Individual counseling sessions with a licensed mental health counselor
    Intervention Type
    Other
    Intervention Name(s)
    Group Counseling
    Intervention Description
    Group counseling sessions with a licensed mental health counselor
    Intervention Type
    Other
    Intervention Name(s)
    Resources
    Intervention Description
    Resource information provided by a licensed mental health counselor
    Primary Outcome Measure Information:
    Title
    Social and Mental Health Outcomes of COVID-19
    Description
    Semi-structured, audio recorded interview to gather information on the SDOH and mental health impacts of COVID-19
    Time Frame
    Up to three weeks
    Title
    Social determinants of health challenges
    Description
    Self-report measure of SDOH needs through the WellRx (Page-Reeves et al., 2016)
    Time Frame
    Up to three weeks
    Title
    Changes in mental health
    Description
    Self-report quantitative measures of depression, anxiety, and wellness
    Time Frame
    At end of study/approx. 12 weeks
    Title
    Program Feasibility/Impact
    Description
    Qualitative data collected via semi-structured exit interviews of participants and their counselors
    Time Frame
    At end of study/approx. 12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: at least 18 years of age received a COVID-19 diagnosis within the last year reports experiencing economic, social, educational, healthcare, and/or environmentally related challenges due to their COVID-19 diagnosis is not currently receiving mental health counseling services resides in one of the following counties in Southern New Mexico (NM): Hidalgo, Grant, Catron, Luna, Doña Ana, Sierra, or Socorro County has access to the internet has not experienced active suicidal or homicidal ideation or active psychosis in the last six months Exclusion Criteria: is not at least 18 years of age has not received a COVID-19 diagnosis within the last year does not report experiencing economic, social, educational, healthcare, and/or environmentally related challenges due to their COVID-19 diagnosis is currently receiving mental health counseling services does not reside in one of the following counties in Southern NM: Hidalgo, Grant, Catron, Luna, Doña Ana, Sierra, or Socorro County does not have access to the internet has experienced active suicidal or homicidal ideation or active psychosis in the last six months
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Alexandra Gantt-Howrey, PhD
    Phone
    5616327355
    Email
    aghowrey@nmsu.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Rebecca Palacios, PhD
    Email
    rpalacio@nmsu.edu

    12. IPD Sharing Statement

    Learn more about this trial

    Mitigating Mental and Social Health Outcomes of COVID-19: A Counseling Approach

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