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

NCT06139159 | Active Not Recruiting

• 1 other identifier: R01MD018206
• Study Type: interventional
• Target: 603
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression, Unipolar; Anxiety Disorders; Post Traumatic Stress Disorder

Keywords

Mental health; Latino health; Immigrant health; Community-health worker

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Depressive symptomatology

  Baseline to 6 months

• Anxiety symptomatology

  Baseline to 6 months

• Post traumatic stress disorder symptomatology

  Baseline to 6 months

Study Arms (3)

LHW as outreach agents/navigators

EXPERIMENTAL

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

LHW as navigators and auxiliary to care

EXPERIMENTAL

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; Other: Auxiliary to care

LHW stepped care and task shifting

EXPERIMENTAL

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: Auxiliary to care; Other: Stepped care and task shifting

Interventions

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

Also known as: Phase 1

LHW as navigators and auxiliary to care; LHW as outreach agents/navigators; LHW stepped care and task shifting

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

Also known as: Phase 2

LHW as navigators and auxiliary to care; LHW stepped care and task shifting

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

Also known as: Phase 3

LHW stepped care and task shifting

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Drexel University: lead
• Esperanza Health Center: collaborator
• The Philadelphia AIDS Consortium: collaborator

Study Sites (1)

Drexel University School of Public Health

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Depressive Disorder; Anxiety Disorders; Stress Disorders, Post-Traumatic; Psychological Well-Being

Interventions

Clinical Trials, Phase I as Topic; Clinical Trials, Phase II as Topic; Clinical Trials, Phase III as Topic

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Personal Satisfaction; Behavior

Intervention Hierarchy (Ancestors)

Clinical Trials as Topic; Clinical Studies as Topic; Epidemiologic Study Characteristics; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Community Health and Prevention

Model Details: 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.

Study Record Dates

• First Submitted: November 15, 2023
• First Posted: November 18, 2023
• Study Start: November 10, 2023
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)