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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06142292
• Other study ID #: IRB-FY2024-98
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: December 15, 2024

Study information

• Verified date: April 2024
• Source: Idaho State University
• Contact: Alexandra Gantt-Howrey, PhD
• Phone: 5616327355
• Email: alexgantthowrey[@]isu.edu
• Is FDA regulated: No
• 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 of2019 (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 howCOVID-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 inSouthern NM. 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 participant's 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.

Other known NCT identifiers

• NCT05739526

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• 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
• 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 Southern New Mexico (NM)
• 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 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

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• Individual counseling
Individual counseling sessions with a licensed mental health counselor
• Group counseling
Group counseling sessions with a licensed mental health counselor

Other:
• Resources
Resource information provided by a licensed mental health counselor

Locations

Country	Name	City	State
United States	Idaho State University	Meridian	Idaho

Sponsors (1)

Lead Sponsor	Collaborator
Idaho State University

Country where clinical trial is conducted

United States, 

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
Primary	Recruitment and retention data	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.	Throughout study, monthly