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

NCT06142292 | Completed

• 1 other identifier: IRB-FY2024-98
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (5)

• 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

• Changes in mental health

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

  Pre/post individual sessions (approx. 12 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

Study Arms (1)

Clients

EXPERIMENTAL

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; Behavioral: Group counseling

Interventions

Individual counseling BEHAVIORAL

Individual counseling sessions with a licensed mental health counselor

Clients

Group counseling BEHAVIORAL

Group counseling sessions with a licensed mental health counselor

Clients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Idaho State University: lead

Study Sites (1)

Idaho State University

Meridian, Idaho, 83642, United States

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2023
• First Posted: November 21, 2023
• Study Start: April 16, 2024
• Primary Completion: January 31, 2025
• Study Completion: February 21, 2025
• Last Updated: February 25, 2025

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)