Social Determinants of HealthNCT06142292
Mitigating Mental and Social Health Outcomes of COVID-19: a Counseling Approach
A study testing Individual counseling and Group counseling in people with Social Determinants of Health and Mental Health Issue, run by Idaho State University at 1 site in United States.
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 of 2019 (COVID-19). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Social Determinants of Health, Mental Health Issue, COVID-19
- What is being tested?
- Individual counseling and Group counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Apr 2024to 21 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Social Determinants of Health, Mental Health Issue, COVID-19
- Being tested
- Individual counseling, Group counseling
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individual counselingBehavioural
Individual counseling sessions with a licensed mental health counselor
Group counselingBehavioural
Group counseling sessions with a licensed mental health counselor
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Individual counseling; Behavioral: Group counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to three weeks
Social determinants of health challenges
Self-report measure of SDOH needs through the WellRx (Page-Reeves et al., 2016)
Measured: Up to three weeks
Changes in mental health
Self-report quantitative measures of depression, anxiety, and wellness
Measured: Pre/post individual sessions (approx. 12 weeks)
Program Feasibility/Impact
Qualitative data collected via semi-structured exit interviews of participants and their counselors
Measured: 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.
Measured: Throughout study, monthly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2023
- Study start16 Apr 2024
- Primary completion31 Jan 2025
- Study completion21 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Social Determinants of HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Idaho State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06142292
- Sponsor's protocol ID
- IRB-FY2024-98
- Status last verified
- Jul 2024
- First submitted
- 17 Nov 2023
- Last updated
- 25 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mitigating Mental and Social Health Outcomes of COVID-19: a Counseling Approach
- ClinicalTrials.gov ID
- NCT06142292
- Acronym / sponsor ID
- IRB-FY2024-98
- Conditions
- Social Determinants of Health, Mental Health Issue, COVID-19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Idaho State UniversityUniversity, hospital or other
- Study start
- 16 Apr 2024 (actual)
- Primary completion
- 31 Jan 2025 (actual)
- Study completion
- 21 Feb 2025 (actual)
- First posted
- 21 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Clients | Experimental | Behavioral: Individual counseling, Behavioral: Group counselingAll participants will be asked to complete the following: participate in 12 individual mental health counseling sessions participate in 3 group counseling sessions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Individual counselingIndividual counseling sessions with a licensed mental health counselor | Behavioural | Clients |
| Group counselingGroup counseling sessions with a licensed mental health counselor | Behavioural | Clients |
Primary outcome
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
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)
Changes in mental health
Time frame: Pre/post individual sessions (approx. 12 weeks)
Self-report quantitative measures of depression, anxiety, and wellness
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
Recruitment and retention data
Time frame: Throughout study, monthly
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individual counseling and Group counseling in people with Social Determinants of Health and Mental Health Issue, run by Idaho State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Social and Mental Health Outcomes of COVID-19 (time frame: Up to three weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2025.