Clinical trial NCT06139159: CRISOL Mente: A Multilevel Community Intervention to Reduce Mental Health Disparities Among Latinos
Official title: CRISOL Mente: A Multilevel Community Intervention to Reduce Mental Health Disparities Among Latinos
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Depression, Unipolar
Anxiety Disorders
Post Traumatic Stress Disorder
Keywords: Mental health
Latino health
Immigrant health
Community-health worker
Lead sponsor: Drexel University
Sponsor class: OTHER
Collaborators: name: Esperanza Health Center
name: The Philadelphia AIDS Consortium
First posted: 2023-11-18
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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).

Eligibility criteria: 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

Primary outcomes:
measure: Improvement in mental health symptomatology (depressive, anxiety or post-traumatic stress disorder [PTSD])
timeFrame: Baseline to 6 months
Secondary outcomes:
measure: Depressive symptomatology
timeFrame: Baseline to 6 months
measure: Anxiety symptomatology
timeFrame: Baseline to 6 months
measure: Post traumatic stress disorder symptomatology
timeFrame: Baseline to 6 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Drexel University School of Public Health
state: Pennsylvania
Study officials:
References: