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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05739526
Other study ID # 2302041890
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date January 15, 2024
Est. completion date December 15, 2024

Study information

Verified date November 2023
Source New Mexico State University
Contact Alexandra Gantt-Howrey, PhD
Phone 5616327355
Email aghowrey@nmsu.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 30
Est. completion date December 15, 2024
Est. primary completion date December 15, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Other:
Individual Counseling
Individual counseling sessions with a licensed mental health counselor
Group Counseling
Group counseling sessions with a licensed mental health counselor
Resources
Resource information provided by a licensed mental health counselor

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
New Mexico State University National Institutes of Health (NIH)

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Up to three weeks
Primary Social determinants of health challenges Self-report measure of SDOH needs through the WellRx (Page-Reeves et al., 2016) Up to three weeks
Primary Changes in mental health Self-report quantitative measures of depression, anxiety, and wellness At end of study/approx. 12 weeks
Primary Program Feasibility/Impact Qualitative data collected via semi-structured exit interviews of participants and their counselors At end of study/approx. 12 weeks
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