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

Not Applicable

Recruiting

• Conditions: Depression, Unipolar; Post Traumatic Stress Disorder; Anxiety Disorders
• Interventions: Other: Outreach/navigator; Other: Auxiliary to care; Other: Stepped care and task shifting

• Registration Number: NCT06139159
• Lead Sponsor: Drexel University

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, we 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. We 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).

Study Timeline

• Status Verified: 2023-11
• Study Start: 2023-11-10
• Study First Submitted: 2023-11-15
• Study First Submitted QC: 2023-11-15
• Last Update Submitted: 2023-11-15
• Study First Posted: 2023-11-18
• Last Update Posted: 2023-11-18
• Primary Completion: 2027-08-31
• Study Completion: 2027-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 600

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
LHW as outreach agents/navigators	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	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, reviews the care plan with the patient and help reduce patient and system barriers impeding psychological well-being, support patients in achieving management goals; 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	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.
LHW stepped care and task shifting	Outreach/navigator	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.
LHW as navigators and auxiliary to care	Outreach/navigator	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, reviews the care plan with the patient and help reduce patient and system barriers impeding psychological well-being, support patients in achieving management goals; 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	Auxiliary to care	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.

Primary Outcome Measures

Name	Time	Method
Improvement in mental health symptomatology (depressive, anxiety or post-traumatic stress disorder [PTSD])	Baseline to 6 months	Clinically meaningful improvement in symptomatology of at least one of depressive, anxiety symptoms and/or PTSD (composite primary outcome) from baseline to the end of 6 months of treatment.; Where improvement is defined as: 1. Epidemiologic Studies Depression Scale Revised (CESD-R10) decline of \>=30% in the overall score or scoring below the cutoff for depressive disorder, and/or; 2. General Anxiety Disorder-7 (GAD-7) decline of \>=30% in the overall score or scoring below the cutoff for anxiety disorder, and/or; 3. PTSD decline of \>=30% in the overall score or scoring below the cutoff for PTSD

Secondary Outcome Measures

Name	Time	Method
Anxiety symptomatology	Baseline to 6 months	Measured using General Anxiety Disorder-7 (GAD-7) scale for anxiety symptoms (continuosly)
Post traumatic stress disorder symptomatology	Baseline to 6 months	Measured using the Short Screening Scale for post-traumatic stress disorder (PTSD).
Depressive symptomatology	Baseline to 6 months	Presence 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)

Trial Locations

Locations (1)

Drexel University School of Public Health; 🇺🇸 Philadelphia, Pennsylvania, United States