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Active, Not Recruiting

NCT Number: NCT06139159

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Drexel University School of Public Health

Philadelphia, Pennsylvania, 19104, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Outreach/navigator

Other
  • 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

Auxiliary to care

Other
  • 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

Stepped care and task shifting

Other
  • 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

Primary outcomes

  1. Improvement in mental health symptomatology (depressive, anxiety or post-traumatic stress disorder [PTSD])

    Time frame: Baseline to 6 months

    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).

Secondary outcomes

  1. Depressive symptomatology

    Time frame: 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)

  2. Anxiety symptomatology

    Time frame: Baseline to 6 months

    Measured using General Anxiety Disorder-7 (GAD-7) scale for anxiety symptoms (continuosly)

  3. Post traumatic stress disorder symptomatology

    Time frame: Baseline to 6 months

    Measured using the Short Screening Scale for post-traumatic stress disorder (PTSD).

Sponsors and collaborators

Lead sponsor

Drexel University

Other

Collaborators

  • Esperanza Health Center
  • The Philadelphia AIDS Consortium

Registry information

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Nov 18, 2023
Registry last updated
Apr 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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