Mental HealthNCT04092777
Building Infrastructure for Community Capacity in Accelerating Integrated Care
A study testing Strong Minds in people with Mental Health, run by Massachusetts General Hospital at 2 sites in United States.
Trial summary
Although the Affordable Care Act (ACA) expanded Medicaid eligibility, Medicaid expansions do not appear to have decreased the gap in mental health treatment between Whites and racial/ethnic or linguistic minorities. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mental Health
- What is being tested?
- Strong Minds
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,044 participants
- Where
- 2 sitesUnited States
- Study dates
- 30 Aug 2019to 16 Nov 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Latino, Asian, Black (African American or Afro-Caribbean), or non-Latino White
- Adult 18+
- Moderate to severe depressive or anxiety symptoms
- Speak English, Spanish, Mandarin, or Cantonese.
Who cannot join
- history of psychosis, mania, or psychotic symptoms according to items from the IMPACT study
- self-reported receipt of specialty mental health treatment within past 3 months or upcoming behavioral health appointment in the next month (pharmacological treatments are not excluded)
- evidence that the patient lacks capacity to consent (measured by a validated screener)
- evidence of current suicidal risk or harm to others (affirmative responses on Paykel suicide questionnaire);
- severe alcohol or substance dependence as defined by score of 70+ on the CAT-SA.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
South Cove Community Health Center
Quincy, Massachusetts, 02171
MGH Broadway Primary Care - Revere
Revere, Massachusetts, 02151
About this study
Official title: 1/2 Building Infrastructure for Community Capacity in Accelerating Integrated Care and 2/2 Building Infrastructure for Community Capacity in Accelerating Integrated Care
Although the Affordable Care Act (ACA) expanded Medicaid eligibility, Medicaid expansions do not appear to have decreased the gap in mental health treatment between Whites and racial/ethnic or linguistic minorities. There is a critical shortage of trained providers who can offer culturally congruent mental health service in non-English languages in Medicaid-based Accountable Care Organizations (ACOs). Building capacity and training opportunities to implement evidence-based mental health interventions by community health workers (CHWs) could expand ACOs infrastructure and increase access to and quality of mental healthcare. To this end, the investigators will test the effectiveness and implementation of the STRONG MINDS model to improve engagement and quality of treatment for depression and anxiety among low-income racial/ethnic and linguistic minority populations, served by Medicaid ACOs. Our proposed study is a Hybrid Type I Effectiveness Implementation study of the effectiveness of the mental health intervention and its impact on study outcomes within varying contexts associated with Medicaid ACOs in North Carolina (NC) and Massachusetts (MA).
Read the detailed description
The investigators will test the STRONG MINDS intervention with adults who have moderate to severe symptoms of depression or anxiety, originally defined as 66+ on the CAT-MH for depression and/or 51+ on the CAT-MH for anxiety. Based on psychometric analyses conducted by the developer of the CAT, Dr. Robert Gibbons has two times adjusted the depression and anxiety thresholds to best map onto moderate symptoms for diverse language groups. As of 10/4/19, the criteria for depression had been changed to a cut-off of 50+ on the CAT-MH depression screener or a positive on the CAT-MH for Major Depressive Disorder (MDD is a positive/negative measure, not a dimensional severity score). As of 12/2020, psychometric analysis showed differences across language groups in symptom severity, and the cut offs were updated to include participants who scored 50+ on the CAT-MH depression in English; a score of 42+ for the CAT-MH depression administered in Spanish or in Chinese. Similarly, the developer of the CAT-MH also changed the cut-off scores for anxiety, with 51+ for the CAT-MH anxiety administered in English; but a score of 41+ for the CAT-MH administered in Spanish or Chinese. The MDD remains a positive/negative item at the same thresholds. These analysis and updates help ensure that the adaptive screener is optimally calibrated to diverse language samples. Eligible participants cannot be receiving mental health care (therapy sessions with psychiatrist, psychologist or social worker) in the past 3 months or in the upcoming month. Participants must speak English, Spanish, Mandarin, or Cantonese. Eligible participants will be consented and assigned to a CHW within the site. After a baseline interview, participants will be randomized to either the intervention or an enhanced usual care condition. Randomization will be stratified by site using a computer-generated block randomization scheme of variable block size. The investigators will monitor engagement in treatment (% of participants with 2 or more mental health sessions/visits in a 6-month period after baseline), mental health symptoms (HSCL-25), overall functioning (WHODAS 2.0), and participant perceived quality of care (PoC) for the intervention group and compare to the enhanced control group. Outcome measures (identified above) will be assessed four times during the study period: at baseline, 3 months, 6 months and 12 months.
Recruitment Strategy: CHWs will screen 6,000 participants with the CAT-MH and substance use measures (for exclusion) in addition to obtaining demographic and social determinants information during the 3.5 years of study screening to identify approximately 1,200 eligible participants across both MA and NC (600 per site). Eligible participants will be randomized to the intervention or enhanced control condition and be invited to complete a baseline assessment as described above. Based on data from our clinical trials, the investigators anticipate that 30-33.5% of those screened will show moderate to severe symptoms of depression and/or anxiety and will not be receiving mental health care. The investigators conservatively anticipate that 60-70% will agree to participate, for approximately 600 cases per site with 20% attrition over a 6 month period.
Sampling, Recruitment and Consent: Community Health Workers (CHWs) and Research Assistants (RAs) will be responsible for approaching potential participants in designated clinics or Community-based Organizations (CBOs). In clinics, CHWs will recruit in waiting rooms or by provider referrals. In community agencies, they will recruit during special community events and meetings. Eligible patients will be scheduled for a baseline interview with a Research Assistant that includes instruments designed to identify elevated mental health symptoms, as well as socio-demographics, cultural, contextual and social factors, medication use, health literacy, language proficiency, past access to health services, migration, patient activation and self-management, and motivation to enter care. Following the baseline interview, participants will be randomized to either the intervention or enhanced usual care (control) condition. Additional interviews will be administered by research assistants blind to study condition at 3-, 6- and 12-months following baseline.
- Conditions
- Mental Health
- Being tested
- Strong Minds, Enhanced Usual Care
- Keywords
- ACOs, Medicaid, Racial, Ethnic, Linguistic, Minorities
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strong MindsBehavioural
The proposed intervention integrates cognitive behavioral therapy techniques combined with mindfulness exercises and promotion of behavioral activation through pleasant activities and developing supportive relationships. The intervention is led by CHWs and organized into 10 sessions, tailored to the participant using a collaborative approach, to improve mood symptoms, augment self-reported functioning, and increase self-reported quality of care among participants with moderate to severe symptoms of depression and/or anxiety. It is complemented by a care manager that links participant to services for needs related to social determinants of health (i.e. education, housing). The intervention has been tailored for delivery by CHWs in Spanish, Mandarin, Cantonese, and English.
Enhanced Usual CareOther
Participants in this arm will receive a booklet about anxiety and depression in Spanish, English, or Mandarin/Cantonese. The Care Manager will call the participant 4 times over the course of 6 months to administer the PROMIS depression (8 item) and anxiety (7 item) short forms, a suicide questionnaire, and a question about medication side effects to mimic the administration schedule in the intervention group. With patient's permission, the care manager will inform the PCP about screening and other assessments and determine if participants should be referred to mental health or substance services and removed from control group given symptom severity.
| Study group | Role | What they receive |
|---|---|---|
| Strong Minds Program | Experimental | This is a 10-session, culturally-adapted intervention, that includes cognitive behavioral therapy techniques combined with mindfulness exercises, led by a Community Health Worker. Receives: Behavioral: Strong Minds |
| Enhanced Usual Care | Other | Enhanced usual care includes check in calls by a Care Manager 4 times over the course of 6 months and educational materials about depression and anxiety. Receives: Other: Enhanced Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Engagement in Mental Health Intervention Sessions
Engagement in Mental Health Intervention Sessions was measured as attending 2 or more (out of 10) sessions of STRONG MINDS. This outcome was measured among intervention participants only (Strong Minds Program) using an indicator variable equal to one if a participant attended 2+ intervention sessions, and equal to zero otherwise.
Measured: 6 months after baseline
Hopkins Symptoms Checklist-25; HSCL-25 (Change)
The Hopkins Symptom Checklist-25 (HSCL-25) is a 25-item measure of self-reported depression and anxiety symptoms in the past two weeks rated on a 4-point scale from 1 'not at all' to 4 'extremely'. Total scores are calculated as the average of all items (range 1 to 4), where higher scores represent worse depression and anxiety symptoms.
Measured: Baseline, 3 months, 6 months, and 12 months after baseline
Functioning: WHODAS 2.0 (Change)
The World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) is a 12-item self-reported measure of level of functioning in six domains: cognition, mobility, self-care, getting along, life activities, and participation. Participants rate difficulties performing activities in each domain in the past 30 days using a 5-point scale from 1 'none' to 5 'extremely or cannot do'. Total scores are calculated as the sum of all items (12 to 60), with higher scores indicating lower functioning levels.
Measured: Baseline, 3 months, 6 months, and 12 months after baseline
Perceptions of Care Outpatient Survey (PoC-OP) (Change)
Perceived quality of care was measured using the Global Evaluation of Care domain of the Perceptions of Care Outpatient Survey (PoC-OP), a clinical-care oriented, self-report satisfaction rating scale assessing patients' perception of the quality of interpersonal care. The Global Evaluation of Care domain includes three items rated on a 4-point scale from 1 'never' to 4 'always', transformed into a score from 0 'lowest quality' to 100 'highest quality'.
Measured: Baseline, 3 months, 6 months, and 12 months after baseline
Secondary outcomes (2)
CAT-MH Depression (Change)
Computerized Adaptive Test for Mental Health (CAT-MH), is a suite of validated computer adaptive tests. CAT-MH scores are based on responses to algorithm-selected items that minimize participant burden using item response theory methodology. The adaptive nature of the CAT-MH targets a participant's specific level of severity at that point in time. The number of items at each time point varies because the same questions are not repeatedly administered. The depression subscale assesses severity of depressive symptoms. Total scores range from 0 to 100 with higher scores indicating worse depression symptoms.
Measured: Baseline, 3 months, 6 months, and 12 months after baseline
CAT-MH Anxiety (Change)
Computerized Adaptive Test for Mental Health (CAT-MH), is a suite of validated computer adaptive tests. CAT-MH scores are based on responses to algorithm-selected items that minimize participant burden using item response theory methodology. The adaptive nature of the CAT-MH targets a participant's specific level of severity at that point in time. The number of items at each time point varies because the same questions are not repeatedly administered. The anxiety subscale assesses severity of anxiety symptoms. Total scores range from 0 to 100 with higher scores indicating worse anxiety symptoms.
Measured: Baseline, 3 months, 6 months, and 12 months after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2019
- Study start30 Aug 2019
- Primary completion16 Nov 2023
- Study completion16 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Mental HealthStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,044 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of North Carolina, Greensboro
- Responsible party
- Principal investigator, Margarita Alegria, PhD, Massachusetts General Hospital
- Investigators
- Margarita Alegria, Ph.D., Principal investigator, Massachusetts General HospitalGabriela Livas Stein, Ph.D., Principal investigator, University of North Carolina, Greensboro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04092777
- Sponsor's protocol ID
- 2018P002918
- Status last verified
- Aug 2025
- First submitted
- 14 Aug 2019
- Last updated
- 26 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Eddington KM, Supple AJ, Poindexter C, Markle S, Livas G, Alegria M. Examining theoretical mediators in a culturally adapted, community health worker-led intervention for depression and anxiety. J Consult Clin Psychol. 2026 Feb;94(2):114-123. doi: 10.1037/ccp0000995.
PubMed 41712341Alegria M, Stein GL, Cruz-Gonzalez M, Falgas-Bague I, Markle SL, Eddington KM, Supple A, Fuentes L, Poindexter C, Shrout PE. Building community capacity in mental health care with the Strong Minds-Strong Communities programme: a randomised controlled trial in the USA. Lancet. 2025 Aug 23;406(10505):832-845. doi: 10.1016/S0140-6736(25)00859-1.
PubMed 40849140
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 1/2 Building Infrastructure for Community Capacity in Accelerating Integrated Care and 2/2 Building Infrastructure for Community Capacity in Accelerating Integrated Care
- ClinicalTrials.gov ID
- NCT04092777
- Acronym / sponsor ID
- 2018P002918
- Conditions
- Mental Health
- Keywords
- ACOs, Medicaid, Racial, Ethnic, Linguistic, Minorities
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,044 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- University of North Carolina, Greensboro
- Study start
- 30 Aug 2019 (actual)
- Primary completion
- 16 Nov 2023 (actual)
- Study completion
- 16 Nov 2023 (actual)
- First posted
- 17 Sep 2019 (actual)
- Results
- Posted 26 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Although the Affordable Care Act (ACA) expanded Medicaid eligibility, Medicaid expansions do not appear to have decreased the gap in mental health treatment between Whites and racial/ethnic or linguistic minorities. There is a critical shortage of trained providers who can offer culturally congruent mental health service in non-English languages in Medicaid-based Accountable Care Organizations (ACOs). Building capacity and training opportunities to implement evidence-based mental health interventions by community health workers (CHWs) could expand ACOs infrastructure and increase access to and quality of mental healthcare. To this end, the investigators will test the effectiveness and implementation of the STRONG MINDS model to improve engagement and quality of treatment for depression and anxiety among low-income racial/ethnic and linguistic minority populations, served by Medicaid ACOs. Our proposed study is a Hybrid Type I Effectiveness Implementation study of the effectiveness of the mental health intervention and its impact on study outcomes within varying contexts associated with Medicaid ACOs in North Carolina (NC) and Massachusetts (MA).
Detailed description
The investigators will test the STRONG MINDS intervention with adults who have moderate to severe symptoms of depression or anxiety, originally defined as 66+ on the CAT-MH for depression and/or 51+ on the CAT-MH for anxiety. Based on psychometric analyses conducted by the developer of the CAT, Dr. Robert Gibbons has two times adjusted the depression and anxiety thresholds to best map onto moderate symptoms for diverse language groups. As of 10/4/19, the criteria for depression had been changed to a cut-off of 50+ on the CAT-MH depression screener or a positive on the CAT-MH for Major Depressive Disorder (MDD is a positive/negative measure, not a dimensional severity score). As of 12/2020, psychometric analysis showed differences across language groups in symptom severity, and the cut offs were updated to include participants who scored 50+ on the CAT-MH depression in English; a score of 42+ for the CAT-MH depression administered in Spanish or in Chinese. Similarly, the developer of the CAT-MH also changed the cut-off scores for anxiety, with 51+ for the CAT-MH anxiety administered in English; but a score of 41+ for the CAT-MH administered in Spanish or Chinese. The MDD remains a positive/negative item at the same thresholds. These analysis and updates help ensure that the adaptive screener is optimally calibrated to diverse language samples. Eligible participants cannot be receiving mental health care (therapy sessions with psychiatrist, psychologist or social worker) in the past 3 months or in the upcoming month. Participants must speak English, Spanish, Mandarin, or Cantonese. Eligible participants will be consented and assigned to a CHW within the site. After a baseline interview, participants will be randomized to either the intervention or an enhanced usual care condition. Randomization will be stratified by site using a computer-generated block randomization scheme of variable block size. The investigators will monitor engagement in treatment (% of participants with 2 or more mental health sessions/visits in a 6-month period after baseline), mental health symptoms (HSCL-25), overall functioning (WHODAS 2.0), and participant perceived quality of care (PoC) for the intervention group and compare to the enhanced control group. Outcome measures (identified above) will be assessed four times during the study period: at baseline, 3 months, 6 months and 12 months.
Recruitment Strategy: CHWs will screen 6,000 participants with the CAT-MH and substance use measures (for exclusion) in addition to obtaining demographic and social determinants information during the 3.5 years of study screening to identify approximately 1,200 eligible participants across both MA and NC (600 per site). Eligible participants will be randomized to the intervention or enhanced control condition and be invited to complete a baseline assessment as described above. Based on data from our clinical trials, the investigators anticipate that 30-33.5% of those screened will show moderate to severe symptoms of depression and/or anxiety and will not be receiving mental health care. The investigators conservatively anticipate that 60-70% will agree to participate, for approximately 600 cases per site with 20% attrition over a 6 month period.
Sampling, Recruitment and Consent: Community Health Workers (CHWs) and Research Assistants (RAs) will be responsible for approaching potential participants in designated clinics or Community-based Organizations (CBOs). In clinics, CHWs will recruit in waiting rooms or by provider referrals. In community agencies, they will recruit during special community events and meetings. Eligible patients will be scheduled for a baseline interview with a Research Assistant that includes instruments designed to identify elevated mental health symptoms, as well as socio-demographics, cultural, contextual and social factors, medication use, health literacy, language proficiency, past access to health services, migration, patient activation and self-management, and motivation to enter care. Following the baseline interview, participants will be randomized to either the intervention or enhanced usual care (control) condition. Additional interviews will be administered by research assistants blind to study condition at 3-, 6- and 12-months following baseline.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Strong Minds Program | Experimental | Behavioral: Strong MindsThis is a 10-session, culturally-adapted intervention, that includes cognitive behavioral therapy techniques combined with mindfulness exercises, led by a Community Health Worker. |
| Enhanced Usual Care | Other | Other: Enhanced Usual CareEnhanced usual care includes check in calls by a Care Manager 4 times over the course of 6 months and educational materials about depression and anxiety. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Latino, Asian, Black (African American or Afro-Caribbean), or non-Latino White
- Adult 18+
- Moderate to severe depressive or anxiety symptoms
- Speak English, Spanish, Mandarin, or Cantonese.
Key exclusion criteria (5 listed)
- history of psychosis, mania, or psychotic symptoms according to items from the IMPACT study
- self-reported receipt of specialty mental health treatment within past 3 months or upcoming behavioral health appointment in the next month (pharmacological treatments are not excluded)
- evidence that the patient lacks capacity to consent (measured by a validated screener)
- evidence of current suicidal risk or harm to others (affirmative responses on Paykel suicide questionnaire);
- severe alcohol or substance dependence as defined by score of 70+ on the CAT-SA.
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 |
|---|---|---|
| Strong MindsThe proposed intervention integrates cognitive behavioral therapy techniques combined with mindfulness exercises and promotion of behavioral activation through pleasant activities and developing supportive relationships. The intervention is led by CHWs and organized into 10 sessions, tailored to the participant using a collaborative approach, to improve mood symptoms, augment self-reported functioning, and increase self-reported quality of care among participants with moderate to severe symptoms of depression and/or anxiety. It is complemented by a care manager that links participant to services for needs related to social determinants of health (i.e. education, housing). The intervention has been tailored for delivery by CHWs in Spanish, Mandarin, Cantonese, and English. | Behavioural | Strong Minds Program |
| Enhanced Usual CareParticipants in this arm will receive a booklet about anxiety and depression in Spanish, English, or Mandarin/Cantonese. The Care Manager will call the participant 4 times over the course of 6 months to administer the PROMIS depression (8 item) and anxiety (7 item) short forms, a suicide questionnaire, and a question about medication side effects to mimic the administration schedule in the intervention group. With patient's permission, the care manager will inform the PCP about screening and other assessments and determine if participants should be referred to mental health or substance services and removed from control group given symptom severity. | Other | Enhanced Usual Care |
Primary outcome
Engagement in Mental Health Intervention Sessions
Time frame: 6 months after baseline
Engagement in Mental Health Intervention Sessions was measured as attending 2 or more (out of 10) sessions of STRONG MINDS. This outcome was measured among intervention participants only (Strong Minds Program) using an indicator variable equal to one if a participant attended 2+ intervention sessions, and equal to zero otherwise.
Hopkins Symptoms Checklist-25; HSCL-25 (Change)
Time frame: Baseline, 3 months, 6 months, and 12 months after baseline
The Hopkins Symptom Checklist-25 (HSCL-25) is a 25-item measure of self-reported depression and anxiety symptoms in the past two weeks rated on a 4-point scale from 1 'not at all' to 4 'extremely'. Total scores are calculated as the average of all items (range 1 to 4), where higher scores represent worse depression and anxiety symptoms.
Functioning: WHODAS 2.0 (Change)
Time frame: Baseline, 3 months, 6 months, and 12 months after baseline
The World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) is a 12-item self-reported measure of level of functioning in six domains: cognition, mobility, self-care, getting along, life activities, and participation. Participants rate difficulties performing activities in each domain in the past 30 days using a 5-point scale from 1 'none' to 5 'extremely or cannot do'. Total scores are calculated as the sum of all items (12 to 60), with higher scores indicating lower functioning levels.
Perceptions of Care Outpatient Survey (PoC-OP) (Change)
Time frame: Baseline, 3 months, 6 months, and 12 months after baseline
Perceived quality of care was measured using the Global Evaluation of Care domain of the Perceptions of Care Outpatient Survey (PoC-OP), a clinical-care oriented, self-report satisfaction rating scale assessing patients' perception of the quality of interpersonal care. The Global Evaluation of Care domain includes three items rated on a 4-point scale from 1 'never' to 4 'always', transformed into a score from 0 'lowest quality' to 100 'highest quality'.
2 secondary outcomes
CAT-MH Depression (Change)
Time frame: Baseline, 3 months, 6 months, and 12 months after baseline
CAT-MH Anxiety (Change)
Time frame: Baseline, 3 months, 6 months, and 12 months after baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41712341Eddington KM, Supple AJ, Poindexter C, Markle S, Livas G, Alegria M. Examining theoretical mediators in a culturally adapted, community health worker-led intervention for depression and anxiety. J Consult Clin Psychol. 2026 Feb;94(2):114-123. doi: 10.1037/ccp0000995.
- Derived from this study: PubMed 40849140Alegria M, Stein GL, Cruz-Gonzalez M, Falgas-Bague I, Markle SL, Eddington KM, Supple A, Fuentes L, Poindexter C, Shrout PE. Building community capacity in mental health care with the Strong Minds-Strong Communities programme: a randomised controlled trial in the USA. Lancet. 2025 Aug 23;406(10505):832-845. doi: 10.1016/S0140-6736(25)00859-1.
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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.
Margarita Alegria, Ph.D. principal investigator
Massachusetts General Hospital
Gabriela Livas Stein, Ph.D. principal investigator
University of North Carolina, Greensboro
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Strong Minds in people with Mental Health, run by Massachusetts General Hospital at 2 sites 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 4 inclusion and 5 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: finished, as of the sponsor's last update on 26 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Yes. Results are posted in the registry (first posted 26 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Engagement in Mental Health Intervention Sessions (time frame: 6 months after baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04092777, which also lists 2 linked publications.
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 26 Aug 2025.