Community Mental Health Intervention for Latino Mental Health Disparities

Overseen By Ana Martinez-Donate, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Drexel University

Disqualifiers: Substance use disorder, Mania, Psychosis, Schizophrenia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 7

Duration: 6 months

600 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to enhance mental health care for the Latino community in Philadelphia by testing a new approach called CRISOL Mente, a multilevel community intervention. Community health workers connect individuals to mental health services and provide basic care. The trial seeks Latino residents of Philadelphia and nearby areas with moderate to severe symptoms of anxiety, depression, or PTSD who are not currently receiving treatment. As an unphased trial, this study offers a unique opportunity to contribute to innovative mental health solutions tailored for the Latino community.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the CRISOL Mente intervention is safe for the Latino community?

Research has shown that the CRISOL Mente program is being tested to improve mental health among Latinos in Philadelphia. While specific safety information from past studies is unavailable, the program is generally considered low-risk because it doesn't involve medication and focuses on community support and mental health services. It typically includes community health workers offering support and resources, which most participants manage well. However, without specific safety data, participants should discuss any concerns with the study team. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the CRISOL Mente trial because it takes a unique approach to addressing mental health disparities in the Latino community. Unlike standard treatments that often require individuals to seek care themselves, this intervention proactively engages community members through outreach by Latino Health Workers (LHWs). This method not only helps identify those who might not have access to traditional mental health services but also builds trust within the community. Additionally, LHWs support patients by navigating them through the healthcare system, providing basic mental health care, and connecting them with necessary social services, which is a unique, more holistic approach compared to conventional treatments. This trial's innovative use of community-based care has the potential to significantly improve accessibility and outcomes for Latino individuals facing mental health challenges.

What evidence suggests that CRISOL Mente could be effective for improving mental health in the Latino community?

Research has shown that community-based programs tailored to cultural needs can significantly improve mental health care access and outcomes for Latinos. In this trial, CRISOL Mente aims to reduce mental health disparities by employing lay health workers (LHW) in various roles. In one arm, LHWs act as outreach agents and navigators, conducting outreach and screening for mental health symptoms. Another arm involves LHWs providing stepped care and task shifting, delivering components of basic evidence-based treatments. In a third arm, LHWs serve as navigators and auxiliaries to care, arranging consultations and assisting with follow-up visits. Early findings suggest that involving LHWs in outreach and care guidance effectively overcomes barriers like language and fear of deportation. This approach seeks to offer affordable, culturally suitable mental health support. Initial results are promising, showing improved access and mental health outcomes in similar community settings. ^{1 2 5 6 7}

Are You a Good Fit for This Trial?

CRISOL Mente is for Latinos aged 18-65 living in specific counties around Philadelphia who self-identify as Latino and have moderate to severe anxiety, depression, or PTSD. It's not for those with high-risk mental health issues, current therapy participants, or pregnant individuals.

Inclusion Criteria

Self-identification as a member of the Latino community

I experience moderate to severe symptoms of anxiety, depression, or PTSD.

Resident of Philadelphia, Bucks, Montgomery, Delaware, or Chester County.

Exclusion Criteria

Pregnancy

People with high-risk mental health symptoms: active suicidality, substance use disorder, mania, psychosis, and schizophrenia

I have been in mental health therapy within the last 3 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Latino lay health workers (LHW) conduct community outreach, screening, referral, and provide basic mental health treatment over 6 months

6 months

Frequent contact with LHWs

Follow-up

Participants are monitored for improvement in mental health symptomatology, including depressive, anxiety, and PTSD symptoms

6 months

Baseline and 6-month surveys

What Are the Treatments Tested in This Trial?

Interventions

• CRISOL Mente

Trial Overview The trial tests CRISOL Mente, a community-based program aiming to improve access to mental health services among Latinos through outreach programs and culturally-tailored care strategies.

How Is the Trial Designed?

Group I: LHW stepped care and task shifting Experimental Treatment 3 Interventions

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.

Group II: LHW as outreach agents/navigators Experimental Treatment 1 Intervention

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.

Group III: LHW as navigators and auxiliary to care Experimental Treatment 2 Interventions

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.

CRISOL Mente is already approved in United States for the following indications:

Approved in United States as CRISOL Mente for:

• Mental health disparities among Latinos

Who Is Running the Clinical Trial?

Drexel University

Lead Sponsor

Trials

160

Recruited

48,600+

The Philadelphia AIDS Consortium

Collaborator

Trials

1

Recruited

600+

Esperanza Health Center

Collaborator

Trials

1

Recruited

600+

Published Research Related to This Trial

The Mentes Positivas en Acción (MPA) program, an 8-week community-based intervention for low-income Spanish-speaking Latinos, significantly reduced stress and depressive symptoms compared to a control group, demonstrating its efficacy in this population.

Participants in the treatment group showed a notable improvement in stress (PSS scores decreased by 0.80) and depressive symptoms (PHQ-9 scores decreased by 5.7), while the control group showed no significant changes until after receiving the program.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mentes Positivas en Acción: A Randomized Feasibility Study of a Promotor-Delivered Cognitive Behavioral Stress Management Program for Low-Income Spanish-Speaking Latinos. Sternberg, RM., Stewart, AL., Nápoles, AM.[2021]

Latinos with serious mental illness have significant healthcare needs, with counseling and therapy services being the most important, as identified by a study involving 122 participants who rated various health needs on a 7-point scale.

There are notable differences in healthcare priorities between U.S.-born Latinos and those born abroad, with over 25% of importance ratings differing significantly, highlighting the need for tailored approaches in integrated care for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prioritizing the healthcare needs of Latinos with mental illness. Corrigan, PW., Torres, A., Lara, JL., et al.[2023]

A study involving 257 low-income Latino patients showed that both telephone and face-to-face cognitive behavioral therapy interventions significantly reduced depression severity compared to usual care, with moderate effect sizes of 0.56 and 0.64, respectively.

The telephone-based intervention had a higher treatment initiation rate (89.7%) compared to face-to-face sessions (78.8%), indicating that telephone care may enhance access to mental health services for Latino patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of the Engagement and Counseling for Latinos (ECLA) intervention in low-income Latinos. Alegría, M., Ludman, E., Kafali, EN., et al.[2021]

The collaboration between academic and community organizations focuses on understanding the attitudes and knowledge regarding mental health care resources within the Latino community.

This initiative aims to create effective interventions and educational outreach models, fostering ongoing partnerships to improve mental health care access and awareness in this community.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reflections on effective nursing partnerships addressing mental health in the Latino community. Garcia, C.[2021]

The ALMA intervention significantly reduced depressive symptoms among Latina immigrants, with participants showing lower levels of depression post-intervention and at a two-month follow-up compared to a comparison group.

The online delivery of the ALMA intervention was particularly effective, leading to greater reductions in both depressive and anxiety symptoms compared to the comparison group, highlighting the adaptability and effectiveness of community-based mental health programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Promoting mental health in Latina immigrant women: Results from the Amigas Latinas Motivando el Alma intervention trial. Ornelas, IJ., Rao, D., Price, C., et al.[2023]

Over one third of residents in a US-Mexico border colonia have been diagnosed with a mental health condition, and more than half report experiencing significant stress and worry, indicating a critical need for mental health support in these communities.

Despite high levels of uninsured individuals, 77% of those diagnosed with mental health issues sought help primarily through primary care providers, highlighting the reliance on general healthcare services for mental health care in low-income populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mental Health Disparities Among Low-Income US Hispanic Residents of a US-Mexico Border Colonia. Marquez-Velarde, G., Grineski, S., Staudt, K.[2021]

Recent research highlights ongoing disparities in mental health care for Latinos, emphasizing the need for targeted interventions to address these gaps, as identified in five significant studies published since 2001.

To effectively reduce these disparities, future research should focus on implementing interventions across multiple pathways to care, such as illness recognition and family support, particularly for conditions like schizophrenia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

From documenting to eliminating disparities in mental health care for Latinos. López, SR., Barrio, C., Kopelowicz, A., et al.[2021]

Latino communities in the U.S. face significant mental health treatment disparities due to factors like stigma and limited mental health literacy, but they often turn to religious congregations for support.

A new study involving 1400 participants from 14 parishes will evaluate a parish-based intervention by NAMI and the Diocese of San Bernardino aimed at reducing stigma and improving mental health literacy, potentially enhancing access to mental health services for Latino parishioners.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A parish-based multilevel cluster randomized controlled trial to reduce stigma and mental health treatment disparities among Latino communities. Wong, EC., Torres, VN., Martinez, MO., et al.[2023]

Citations

1. reporter.nih.gov reporter.nih.gov/project-details/10597875

CRISOL Mente This 5-year project seeks to develop and test a multi-level, community intervention to improve mental health outcomes and promote access to culturally ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06139159

CRISOL Mente: A Multilevel Community Intervention to ... This 5-year project seeks to develop and test a multi-level, community intervention to improve mental health outcomes and promote access to culturally ...

3. highergov.com highergov.com/grant/R01MD018206/

Crisol Mente: Latino Mental Health Intervention This 5-year project seeks to develop and test a multi-level, community intervention to improve mental health outcomes and promote access to culturally ...

4. ctv.veeva.com ctv.veeva.com/study/crisol-mente-a-multilevel-community-intervention-to-reduce-mental-health-disparities-among-latinos

CRISOL Mente: A Multilevel Community Intervention to Reduce ... This 5-year project seeks to develop and test a multi-level, community intervention to improve mental health outcomes and promote access to culturally ...

5. withpower.com withpower.com/trial/community-mental-health-intervention-for-latino-mental-health-disparities-152da

Community Mental Health Intervention for Latino ... The research highlights the importance of culturally adapted, community-based interventions for improving mental health care access and outcomes among Latinos, ...

6. trialx.com trialx.com/clinical-trials/listings/218697/crisol-mente-a-multilevel-community-intervention-to-reduce-mental-health-disparities-among-latinos/

CRISOL Mente: A Multilevel Community Intervention to ... This 5-year project seeks to develop and test a multi-level, community intervention to improve mental health outcomes and promote access to ...

7. reporter.nih.gov reporter.nih.gov/search/HVWWSSl0VkKUiTW104LHrg/project-details/11160435

Project Details This project will address that need by implementing and testing CRISOL Mente, a multi-level, community-engaged intervention to improve access to mental health ...