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CRISOL Mente: A Multilevel Community Intervention to Reduce Mental Health Disparities Among Latinos

CRISOL Mente: A Multilevel Community Intervention to Reduce Mental Health Disparities Among Latinos

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06139159
Enrollment
603
Registered
2023-11-18
Start date
2023-11-10
Completion date
2027-08-31
Last updated
2026-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety Disorders, Depression, Unipolar, Post Traumatic Stress Disorder

Keywords

Mental health, Latino health, Immigrant health, Community-health worker

Brief summary

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.

Detailed description

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).

Interventions

OTHEROutreach/navigator

* Conduct outreach activities with people in the community who are hard to reach and with limited access to health care, conduct informal screening for symptoms of mental illnesses, encourage and refer individuals at-risk, suspected of having, or affected by mental health issues to clinics for triage. * Document outreach, screening, and referral activities in LHW database

OTHERAuxiliary to care

* Arrange consultation for those at-risk, suspected, or affected individuals at clinics for triage. * Introduce the patient to the clinical team via a "warm hand-off" and assist in scheduling a follow -up visit. * Support patients in attending their clinic visits; help patients address barriers through education, referral, and navigation to ancillary community services (SAVAME, legal, housing, economic, etc); * Engage, activate, and empower patients to participate in the care process * Frequent contact with patients: +1 every two weeks during the first 3 months, +1 every month for months 4-6. * Assist with group sessions: affinity groups * Identify community-based resources. * Document outreach, screening, referral, and auxiliary care activities in LHW database

OTHERStepped care and task shifting

* Support counselling initiated by the psychologist * Reinforce patient education about depression, anxiety, trauma, and other syndemic conditions. * Work with patients' families and peers to reduce stigma, address syndemic factors and social conditions. * Contact frequency with patients: +1 every two weeks during the first 3 months, +1 every month for months 4-6. * Co-lead group sessions: affinity groups * Provide Mental Health First Aid to members of the community. * Document outreach, screening, referral, auxiliary and stepped care activities in LHW database

Sponsors

Drexel University
Lead SponsorOTHER
Esperanza Health Center
CollaboratorUNKNOWN
The Philadelphia AIDS Consortium
CollaboratorUNKNOWN

Study design

Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention model description

Our team vision is to develop a multi-level community-based model that is more pragmatic, efficient and effective than programs that address only one level of the socioecological model or rely solely on highly trained mental health professionals, who do not always have the necessary cultural or linguistical competency and are not affordable to many Latino-serving organizations. By tackling multiple levels and domains of influence, and leveraging heavily on cultural and context concordant actors, this project can pave the way for a new, scalable, and sustainable model to improve mental health and mental health treatment among Latino communities in the U.S. The comparison of the three phases can help to identify the optimal level of involvement by the LHWs.

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Improvement in mental health symptomatology (depressive, anxiety or post-traumatic stress disorder [PTSD])Baseline to 6 monthsImprovement is a composite measure defined as change in any of the mental health outcomes. The following scales and categories will be used to define improvement. * Depressive symptoms: decrease in from CESD-10 at bsl \>=10 to CESD-10 \<10 at 6-month, among those with CESD-10 \>=10 at baseline, OR * Anxiety symptoms: decrease in GAD7 category from bsl to 6-month: from 15-21(severe) to 10-14 (moderate) or from 15-21(severe) to less than 10 (mild or minimal anxiety), or from 10-14 bsl (moderate) to less than 10 (mild or minimal anxiety), among those with GAD7 \>=10 at baseline, OR * For PTSD, decrease from in PTSD category from bsl to 6 months: from \>=3 to PTSD \<3, among those with PTSD\>=3 at baseline).

Secondary

MeasureTime frameDescription
Depressive symptomatologyBaseline to 6 monthsPresence or absence of any clinical mental health disorder will be determined using Center for Measured using Epidemiologic Studies Depression Scale Revised (CESD-R10) for depressive symptoms (continuously)
Anxiety symptomatologyBaseline to 6 monthsMeasured using General Anxiety Disorder-7 (GAD-7) scale for anxiety symptoms (continuosly)
Post traumatic stress disorder symptomatologyBaseline to 6 monthsMeasured using the Short Screening Scale for post-traumatic stress disorder (PTSD).

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 16, 2026