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Completed

NCT Number: NCT06142292

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

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.

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Key information

Conditions

Social Determinants of Health COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Mental Health Issue Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Idaho State University

Meridian, Idaho, 83642, United States

About this study

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 New Mexico (NM) and Idaho (ID). 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 NM and ID. This research will include in-depth assessment of participants' SDOH needs pertinent to COVID-19. Counseling may cover topics directly related, but also adjacent, to the participants' COVID-19 diagnosis and its impact. 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • at least 18 years of age
  • tested positive for COVID-19 at some point in time
  • 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 the State of New Mexico (NM) or the State of Idaho (ID)
  • has access to the internet (not necessary for counseling services, but to complete interviews/assessments)
  • 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 have access to the internet
  • has experienced active suicidal or homicidal ideation or active psychosis in the last six months

Treatment and study plan

Individual counseling

Behavioral

Individual counseling sessions with a licensed mental health counselor

Group counseling

Behavioral

Group counseling sessions with a licensed mental health counselor

Primary outcomes

  1. Social and Mental Health Outcomes of COVID-19

    Time frame: Up to three weeks

    Semi-structured, audio recorded interview to gather information on the SDOH and mental health impacts of COVID-19

  2. Social determinants of health challenges

    Time frame: Up to three weeks

    Self-report measure of SDOH needs through the WellRx (Page-Reeves et al., 2016)

  3. Changes in mental health

    Time frame: Pre/post individual sessions (approx. 12 weeks)

    Self-report quantitative measures of depression, anxiety, and wellness

  4. Program Feasibility/Impact

    Time frame: At end of study/approx. 12 weeks

    Qualitative data collected via semi-structured exit interviews of participants and their counselors

  5. Recruitment and retention data

    Time frame: Throughout study, monthly

    To understand the feasibility of this study, the investigator will note how many individuals were recruited for the study (Months 1 and 2), the number of individuals who consent to participate (Months 1 and 2), and then in subsequent months, the investigator will note the number of participants who remain in the study. Each month, the investigator will also make note of how many self-report measures each participant completes on a monthly basis.

Sponsors and collaborators

Lead sponsor

Idaho State University

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 21, 2023
Registry last updated
Feb 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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