跳至主要内容
临床试验/NCT06139159
NCT06139159
进行中(未招募)
不适用

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

Drexel University2 个研究点 分布在 1 个国家目标入组 603 人2023年11月10日

概览

阶段
不适用
干预措施
Auxiliary to care
疾病 / 适应症
Depression, Unipolar
发起方
Drexel University
入组人数
603
试验地点
2
主要终点
Improvement in mental health symptomatology (depressive, anxiety or post-traumatic stress disorder [PTSD])
状态
进行中(未招募)
最后更新
17天前

概览

简要总结

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.

详细描述

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).

注册库
clinicaltrials.gov
开始日期
2023年11月10日
结束日期
2027年8月31日
最后更新
17天前
研究类型
Interventional
研究设计
Sequential
性别
All

研究者

责任方
Principal Investigator
主要研究者

Ana Martinez Donate

Professor of Community Health and Prevention

Drexel University

入排标准

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

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, 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.

干预措施: Auxiliary to care

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.

干预措施: Outreach/navigator

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.

干预措施: Outreach/navigator

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, 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.

干预措施: Outreach/navigator

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.

干预措施: Auxiliary to care

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.

干预措施: Stepped care and task shifting

结局指标

主要结局

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

时间窗: 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).

次要结局

  • Anxiety symptomatology(Baseline to 6 months)
  • Post traumatic stress disorder symptomatology(Baseline to 6 months)
  • Depressive symptomatology(Baseline to 6 months)

研究点 (2)

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