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

Sponsor

Drexel University (Other)

Overall Status

Recruiting

CT.gov ID

NCT06139159

Collaborator

Esperanza Health Center (Other), The Philadelphia AIDS Consortium (Other)

600

Enrollment

Location

Arms

45.7

Anticipated Duration (Months)

13.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Depression, Unipolar Anxiety Disorders Post Traumatic Stress Disorder	Other: Outreach/navigator Other: Auxiliary to care Other: Stepped care and task shifting	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

600 participants

Allocation:

Non-Randomized

Intervention Model:

Sequential Assignment

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.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.

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

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

Actual Study Start Date :

Nov 10, 2023

Anticipated Primary Completion Date :

Aug 31, 2027

Anticipated Study Completion Date :

Aug 31, 2027

Arms and Interventions

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 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, 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.	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. Reviews care plan with patient and help reduce patient and system barriers impeding psychological wellbeing Support patients in achieving management goals; 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 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: 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. Reviews care plan with patient and help reduce patient and system barriers impeding psychological wellbeing Support patients in achieving management goals; 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 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

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 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, 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.

Other: Outreach/navigator

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. Reviews care plan with patient and help reduce patient and system barriers impeding psychological wellbeing Support patients in achieving management goals; 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 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

Other Names:

Phase 1

Other: Auxiliary to care

Other Names:

Phase 2

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

Outcome Measures

Primary Outcome Measures

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: Epidemiologic Studies Depression Scale Revised (CESD-R10) decline of >=30% in the overall score or scoring below the cutoff for depressive disorder, and/or General Anxiety Disorder-7 (GAD-7) decline of >=30% in the overall score or scoring below the cutoff for anxiety disorder, and/or PTSD decline of >=30% in the overall score or scoring below the cutoff for PTSD

Secondary Outcome Measures

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)
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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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