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

Anxiety Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06139159
• Other study ID #: R01MD018206
• Status: Recruiting
• Phase: N/A
• Start date: November 10, 2023
• Est. completion date: August 31, 2027

Study information

• Verified date: November 2023
• Source: Drexel University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: August 31, 2027
• Est. primary completion date: August 31, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorders
• Depression, Unipolar
• Depressive Disorder
• Post Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

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
• 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
• 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

Locations

Country	Name	City	State
United States	Drexel University School of Public Health	Philadelphia	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
Drexel University	Esperanza Health Center, The Philadelphia AIDS Consortium

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in mental health symptomatology (depressive, anxiety or post-traumatic stress disorder [PTSD])	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	Baseline to 6 months
Secondary	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
Secondary	Anxiety symptomatology	Measured using General Anxiety Disorder-7 (GAD-7) scale for anxiety symptoms (continuosly)	Baseline to 6 months
Secondary	Post traumatic stress disorder symptomatology	Measured using the Short Screening Scale for post-traumatic stress disorder (PTSD).	Baseline to 6 months