| Registry | NCT06139159 |
|---|---|
| Status | Active not recruiting |
| Phase | Not applicable |
| Study type | Interventional; non randomized, sequential, masking: none, health services research |
| Enrollment | 603 (Actual) |
| Sponsor | Drexel University (Other); collaborators: Esperanza Health Center, The Philadelphia AIDS Consortium |
| Conditions | Depression, Unipolar, Anxiety Disorders, Post Traumatic Stress Disorder |
| Interventions | Outreach/navigator, Auxiliary to care, Stepped care and task shifting (Other) |
| Dates | start 2023-11-10, primary completion 2027-08-31 (estimated), completion 2027-08-31 (estimated), first posted 2023-11-18, last updated 2026-04-15 |
| Locations | 1 site in United States |
Related Papers Related Patents Related Grants Related Experts
All trials for Depression, Unipolar All trials for Anxiety Disorders All trials of Outreach/navigator All trials of Auxiliary to care
Latinos in the U.S. experience significant disparities in access to mental health services due to lack of health insurance, language barriers, low availability of bilingual providers, mental health stigma, and fear of deportation. There is an urgent need to identify low-cost, culturally appropriate interventions to reduce mental health disparities among this population. This project will address that need by implementing and testing CRISOL Mente, a multi-level, culturally-congruent community intervention to improve the mental health of the Latino population in Philadelphia.
Latinos in the U.S. experience significant disparities in access to mental health services due to lack of health insurance, cost of services, limited awareness of mental health resources, mental health stigma, and fear of deportation. Limited English proficiency coupled with an acute lack of bilingual and culturally competent providers further impede Latinos' adequate access to quality mental health services. The COVID-19 pandemic has only amplified the need for mental health care and exacerbated mental health disparities for Latino communities, making it urgent to identify low-cost, effective strategies to reduce these gaps. This 5-year project seeks to develop and test a multi-level, community intervention to improve mental health outcomes and promote access to culturally appropriate mental health treatment for Latino communities in Philadelphia. CRISOL Mente will include components at various levels of the socio-ecological model: a clinic-based, stepped-care program relying on Latino lay health workers (LHW) for the delivery of mental health services.
To improve mental health symptoms and engagement in care, the investigators will recruit, train and supervise a cohort of Latino LHW who will be embedded into two Latino-serving clinics, extending the reach and effectiveness of the clinics' mental health services. The investigators will compare the impact of three different levels of LHW involvement: a) community outreach/navigation (i.e. screening and referral of community members); b) auxiliary care (i.e. screening, referral, and help overcoming barriers to better mental health); and c) task shifting (i.e. screening, referral, assistance, and supervised delivery of basic mental health treatment). The LHWs will also conduct outreach/education activities in the community (e.g. radio talks, info sessions, tables in community venues) to reduce mental health stigma. Our experienced and largely Latino community-academic research team will also engage in capacity building activities (i.e. monthly town halls, annual retreats, weekly newsletters, provision of trainings and technical support) with the Latino Health Collective, a coalition of Latino-serving organizations. Using mixed-methods and the RE-AIM framework, CRISOL Mente's impact will be evaluated with clinical data, baseline and 6-month patient survey data (N=200 from each level of LHW involvement, total n=600).
| Arm | Type | Interventions | Description |
|---|---|---|---|
| LHW as outreach agents/navigators | Experimental | Other: Outreach/navigator | Conduct outreach activities with people in the community who are hard to reach and with limited access to health care, conduct screening for symptoms of mental illnesses, encourage and refer individuals at-risk, suspected of having, or affected by mental health issues for further triage. |
| LHW as navigators and auxiliary to care | Experimental | Other: Outreach/navigator; Other: Auxiliary to care | LHW continue conducting outreach and referral activities but in addition, LHW are more involved in their care. They arrange consultations, introduce the patient to the clinical team via a "warm hand-off" and assist in scheduling a follow-up visit, help patients comply with the follow-up appointments, help reduce patient and system barriers impeding their care; help patients address barriers through education, referral, and navigation to ancillary community services. They have frequent contact with the patient. |
| LHW stepped care and task shifting | Experimental | Other: Outreach/navigator; Other: Auxiliary to care; Other: Stepped care and task shifting | LHW conduct activities of prior arms but in addition, they may provide specific components of mental health care (task-shifting), providing components of basic evidence-based treatments to patients with non-complex needs, and addressing other syndemic health and social conditions. |
Sex: All, ages: 18 Years to 65 Years
Inclusion Criteria: * Ages 18-65 * Fluent in English or Spanish * Self-identification as a member of the Latino community * Resident of Philadelphia, Bucks, Montgomery, Delaware, or Chester County. * Moderate to severe clinical symptoms of anxiety, depression, and/or PTSD Exclusion Criteria: * People with high-risk mental health symptoms: active suicidality, substance use disorder, mania, psychosis, and schizophrenia * People already receiving mental health therapy (in the last 3 months) * Pregnancy
| Facility | City | Country | Status |
|---|---|---|---|
| Drexel University School of Public Health | Philadelphia, Pennsylvania | United States |