Study Enrollment


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Clinical Trial

COVID, Mental Health, and Soul Study (CMAS STUDY)

The overall aim of this study is to utilize Church Health Workers (CHWs) to screen for depression among COVID-19 survived individuals in a Black church and compare the effectiveness of Screening, Brief Intervention, and Referral to Treatment (SBIRT) (Intervention arm) to Referral As Usual (RAU; Control arm) on treatment engagement for depression in this prospective cohort study. The investigators will assess patient-level outcomes (Mental-Health Related Quality of Life and depressive symptoms) at 3- and 6-months post-screening and conduct a mixed-methods process evaluation to assess multi-level facilitators and barriers of screening uptake. We will screen 200 COVID-19 survivors, yielding a sample of 70 participants with Patient Health Questionnaire-9 score ? 10, age 18 and above, and all sexes. Subjects will be randomized to either SBIRT (n=35) or RAU (n=35). The investigators will then compare the effectiveness of SBIRT (Intervention arm) among subjects to RAU (Control/Usual Care arm) on treatment engagement (primary outcome), defined as attending a depression-related clinical visit for which the subject reported receiving information, referral, counseling, or medication for depression (Aim 1). The investigators will then compare changes in Mental Health Related Quality of Life and depressive symptoms (secondary outcomes) at 3- and 6-months post-screening (Aim 2). Finally, the investigators will conduct a concurrent, mixed-methods (qualitative-quantitative) process evaluation to assess contextual facilitators and barriers of screening and referral (Aim 3). This research seeks to employ strategic partnerships and community engagement / participation to enhance research capacity and infrastructure in underserved populations.


Eligibility Criteria

  • Inclusion Criteria: Self-reported African American (AAs) COVID-19 survivors at the screening before the baseline data collection. Severity and Post-acute sequelae SARS-CoV-2 infection (PASC) diagnosis is not feasible for this study. We will ask for diagnosis report if available, but it is not mandatory for inclusion in the study. Adults 18 years and older and all sexes. Fluent in English. Patient Health Questionnaire-9 score ? 10. Exclusion Criteria: Reporting active suicidality, or verbally endorsing homicidal. Currently receiving formal mental health treatment. If any churchgoer comes for screening and makes any comments or reports any thoughts of suicidality or being homicidal to Church health workers or any other study team members present, they will be assessed with the Columbia-Suicide Severity Rating Scale (C-SSRS). The CHWs will focus on reviewing PHQ-9 scores at the screening process and consenting eligible adults who screen positive for the Randomized Controlled Trial. When the prospective participant has completed the PHQ-9, the CHW will briefly calculate their total PHQ-9 score and assess for suicidality. If a research participant endorses suicidal ideation either verbally or on the PHQ-9, the CHWs will screen for suicidality with the Columbia-Suicide Severity Rating Scale (C-SSRS). If necessary, the CHW will immediately contact the on-call clinician/Co-Investigators, who will conduct a standardized clinical assessment to evaluate immediacy of suicidal risk and if the research participant has active suicidal ideation/behavior, the on-call clinician will refer the participant to immediate clinical care by either calling 911 or the on-call clinician/Co-Investigators will refer the participant for an in-person clinical assessment within 48 hours. Dr. Vaughn McCall, MD and Dr. Peter Rosenquist, MD will function as on-call clinicians and if the psychological service is required, Dr. Sabina Widner will function as the Psychologist. Dr. Victoria Burt, a nurse practitioner, will be available for other medical needs, if necessary. Columbia-Suicide Severity Rating Scale (C-SSRS) will be used throughout the study if any participant reports being suicidal or homicidal and then we will follow the above given protocol to take care of the situation. This is a teamwork and research team are included experts in each field for conducting this study. All investigators are responsible for screening, consenting, and providing education. Two questions are added to the ?official use? portion of the screening form to record this information as Verbally endorses active suicidality, or is homicidal yes/no Was the C-SSRS form administered yes/no

Contact Information

    Thomas V. Joshua, PhD, MS

    706.721.4093

   TJOSHUA@augusta.edu

RESEARCH. INNOVATION. DISCOVERY.