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.

Study Overview

• Status: Completed
• Conditions: COVID-19; Mental Health Issue; Social Determinants of Health
• Intervention / Treatment: Behavioral: Individual counseling; Behavioral: Group counseling

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 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.

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Idaho
    • Meridian, Idaho, United States, 83642
      • Idaho State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Clients; All participants will be asked to complete the following: participate in 12 individual mental health counseling sessions participate in 3 group counseling sessions	Behavioral: Individual counseling; Individual counseling sessions with a licensed mental health counselor; Behavioral: Group counseling; Group counseling sessions with a licensed mental health counselor

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Idaho State University

Study record dates

Study Major Dates

• Study Start (Actual): April 16, 2024
• Primary Completion (Actual): January 31, 2025
• Study Completion (Actual): February 21, 2025

Study Registration Dates

• First Submitted: November 17, 2023
• First Submitted That Met QC Criteria: November 17, 2023
• First Posted (Actual): November 21, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 24, 2025
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; COVID-19
• Other Study ID Numbers: IRB-FY2024-98

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No