- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05739526
Mitigating Mental and Social Health Outcomes of COVID-19: A Counseling Approach
November 9, 2023 updated by: New Mexico State University
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
Not yet recruiting
Intervention / Treatment
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 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.
Study Type
Interventional
Enrollment (Estimated)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Alexandra Gantt-Howrey, PhD
- Phone Number: 5616327355
- Email: aghowrey@nmsu.edu
Study Contact Backup
- Name: Rebecca Palacios, PhD
- Email: rpalacio@nmsu.edu
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Participants
All participants will be asked to complete the following:
|
Individual counseling sessions with a licensed mental health counselor
Group counseling sessions with a licensed mental health counselor
Resource information provided by 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
Time Frame: Up to three weeks
|
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
Time Frame: Up to three weeks
|
Self-report measure of SDOH needs through the WellRx (Page-Reeves et al., 2016)
|
Up to three weeks
|
|
Changes in mental health
Time Frame: At end of study/approx. 12 weeks
|
Self-report quantitative measures of depression, anxiety, and wellness
|
At end of study/approx. 12 weeks
|
|
Program Feasibility/Impact
Time Frame: At end of study/approx. 12 weeks
|
Qualitative data collected via semi-structured exit interviews of participants and their counselors
|
At end of study/approx. 12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
January 15, 2024
Primary Completion (Estimated)
December 15, 2024
Study Completion (Estimated)
December 15, 2024
Study Registration Dates
First Submitted
February 17, 2023
First Submitted That Met QC Criteria
February 20, 2023
First Posted (Actual)
February 22, 2023
Study Record Updates
Last Update Posted (Estimated)
November 13, 2023
Last Update Submitted That Met QC Criteria
November 9, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2302041890
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.