Depression, UnipolarNCT06139159
CRISOL Mente: A Multilevel Community Intervention to Reduce Mental Health Disparities Among Latinos
A study testing Outreach/navigator, Auxiliary to care and Stepped care and task shifting in people with Depression, Unipolar and Anxiety Disorders, run by Drexel University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression, Unipolar, Anxiety Disorders, Post Traumatic Stress Disorder
- What is being tested?
- Outreach/navigator, Auxiliary to care and Stepped care and task shifting
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 603 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Nov 2023to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Drexel University School of Public Health
Philadelphia, Pennsylvania, 19104
About this study
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.
Read the detailed 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, 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).
- Being tested
- Outreach/navigator, Auxiliary to care, Stepped care and task shifting
- Keywords
- Mental health, Latino health, Immigrant health, Community-health worker
- Medical subject headings
- Depressive Disorder, Anxiety Disorders, Stress Disorders, Post-Traumatic, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Outreach/navigatorOther
Also called Phase 1
- 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 careOther
Also called Phase 2
- 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
Stepped care and task shiftingOther
Also called Phase 3
- 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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Outreach/navigator; Other: Auxiliary to care; Other: Stepped care and task shifting |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline to 6 months
Secondary outcomes (3)
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)
Measured: Baseline to 6 months
Anxiety symptomatology
Measured using General Anxiety Disorder-7 (GAD-7) scale for anxiety symptoms (continuosly)
Measured: Baseline to 6 months
Post traumatic stress disorder symptomatology
Measured using the Short Screening Scale for post-traumatic stress disorder (PTSD).
Measured: Baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start10 Nov 2023
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression, UnipolarStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 603 participants (actual)
Sponsor and investigators
- Lead sponsor
- Drexel University
- Sponsor type
- University, hospital or other
- Collaborators
- Esperanza Health Center, The Philadelphia AIDS Consortium
- Responsible party
- Principal investigator, Ana Martinez Donate, Drexel University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06139159
- Sponsor's protocol ID
- R01MD018206
- Status last verified
- Apr 2026
- First submitted
- 15 Nov 2023
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CRISOL Mente: A Multilevel Community Intervention to Reduce Mental Health Disparities Among Latinos
- ClinicalTrials.gov ID
- NCT06139159
- Acronym / sponsor ID
- R01MD018206
- Keywords
- Mental health, Latino health, Immigrant health, Community-health worker
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 603 participants (actual)
- Lead sponsor
- Drexel UniversityUniversity, hospital or other
- Collaborators
- Esperanza Health Center, The Philadelphia AIDS Consortium
- Study start
- 10 Nov 2023 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 18 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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, 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).
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| LHW as outreach agents/navigators | Experimental | Other: Outreach/navigatorConduct 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. |
| LHW as navigators and auxiliary to care | Experimental | Other: Outreach/navigator, Other: Auxiliary to careLHW 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. |
| LHW stepped care and task shifting | Experimental | Other: Outreach/navigator, Other: Auxiliary to care, Other: Stepped care and task shiftingLHW 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Outreach/navigatorAlso: Phase 1* 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 | LHW as navigators and auxiliary to care, LHW as outreach agents/navigators, LHW stepped care and task shifting |
| Auxiliary to careAlso: Phase 2* 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 | LHW as navigators and auxiliary to care, LHW stepped care and task shifting |
| Stepped care and task shiftingAlso: Phase 3* 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 | LHW stepped care and task shifting |
Primary outcome
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).
3 secondary outcomes
Depressive symptomatology
Time frame: Baseline to 6 months
Anxiety symptomatology
Time frame: Baseline to 6 months
Post traumatic stress disorder symptomatology
Time frame: Baseline to 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Outreach/navigator, Auxiliary to care and Stepped care and task shifting in people with Depression, Unipolar and Anxiety Disorders, run by Drexel University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in mental health symptomatology (depressive, anxiety or post-traumatic stress disorder [PTSD]) (time frame: Baseline to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026.