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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Anxiety Disorders; Post Traumatic Stress Disorder; Depression, Unipolar
• Intervention / Treatment: Other: Outreach/navigator; Other: Stepped care and task shifting; Other: Auxiliary to care

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).

• Study Type: Interventional
• Enrollment (Actual): 603
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Drexel University School of Public Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LHW as outreach agents/navigators; 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.	Other: Outreach/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; Other Names: Phase 1
Experimental: LHW 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.	Other: Outreach/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; Other Names: Phase 1; Other: Stepped 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; Other Names: Phase 3; Other: Auxiliary 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; Other Names: Phase 2
Experimental: LHW as navigators and 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.	Other: Outreach/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; Other Names: Phase 1; Other: Auxiliary 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; Other Names: Phase 2

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in mental health symptomatology (depressive, anxiety or post-traumatic stress disorder [PTSD])	Improvement 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).	Baseline to 6 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Drexel University
• Collaborators: Esperanza Health Center; The Philadelphia AIDS Consortium

Study record dates

Study Major Dates

• Study Start (Actual): November 10, 2023
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027

Study Registration Dates

• First Submitted: November 15, 2023
• First Submitted That Met QC Criteria: November 15, 2023
• First Posted (Actual): November 18, 2023

Study Record Updates

• Last Update Posted (Actual): April 15, 2026
• Last Update Submitted That Met QC Criteria: April 10, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Mental health; Latino health; Immigrant health; Community-health worker
• Additional Relevant MeSH Terms: Trauma and Stressor Related Disorders; Mental Disorders; Mood Disorders; Stress Disorders, Traumatic; Behavior; Personal Satisfaction; Anxiety Disorders; Depressive Disorder; Stress Disorders, Post-Traumatic; Psychological Well-Being; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Epidemiologic Study Characteristics; Clinical Trials as Topic; Clinical Studies as Topic; Clinical Trials, Phase I as Topic; Clinical Trials, Phase II as Topic; Clinical Trials, Phase III as Topic
• Other Study ID Numbers: R01MD018206 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No