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

Sponsor
Idaho State University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06142292
Collaborator
(none)
40
1
11

Study Details

Study Description

Brief Summary

The goal of this clinical trial is to develop a comprehensive mental health counseling programpurposed 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 themental and social determinant of health impacts of a COVID-19 diagnosis, and 2) What are theimpacts of a counseling program implemented to address those impacts? Participants willparticipate in individual interviews, attend individual and group counseling, and be providedresources related to their social determinants of health needs.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Individual counseling
  • Behavioral: Group counseling
  • Other: Resources
N/A

Detailed Description

The social determinants of health (SDOH) are an important social justice issue affectingvarious quality of life outcomes (e.g., physical and mental health). COVID-19 hasdisproportionately affected the SDOH of underserved and minority communities, includingthose in Southern New Mexico (NM). However, there is a lack of research on specifi cally howCOVID-19 has affected individuals' SDOH, inhibiting prevention and response from mentalhealth professionals and their interprofessional collaborators. Counselor educationresearchers have also not yet conducted outcome-based studies in this area. This researchwill support the development of a comprehensive, SDOH-focused mental health counselingprogram 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 needspertinent to COVID-19. Counseling may cover topics directly related, but also adjacent, to theparticipant's COVID-19 diagnosis and its impact. Participants will be provided resources andreferrals specifi c to those needs, and engage in individual and group mental health counselingservices 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) themental health and SDOH-related impacts of such a counseling program.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Mitigating Mental and Social Health Outcomes of COVID-19: A Counseling Approach
Anticipated Study Start Date :
Jan 15, 2024
Anticipated Primary Completion Date :
Dec 15, 2024
Anticipated Study Completion Date :
Dec 15, 2024

Arms and Interventions

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 receive information on community resources related to their social andmental health needs/challenges

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

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

Other: Resources
Resource information provided by a licensed mental healthcounselor

Outcome Measures

Primary Outcome Measures

  1. Social and Mental Health Outcomes of COVID-19 [Up to three weeks]

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

  2. Social determinants of health challenges [Up to three weeks]

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

  3. Changes in mental health [At end of study/approx. 12 weeks]

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

  4. Program Feasibility/Impact [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 [Throughout study, monthly]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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 (not necessary for counseling services, but to complete interviews/assessments)

  • has not experienced active suicidal or homicidal ideation or active psychosis in the lastsix 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Idaho State University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Idaho State University
ClinicalTrials.gov Identifier:
NCT05739526
Other Study ID Numbers:
  • IRB-FY2024-98
  • NCT05739526
First Posted:
Nov 21, 2023
Last Update Posted:
Nov 21, 2023
Last Verified:
Nov 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 21, 2023