N/A
N=1,044
Building Infrastructure for Community Capacity in Accelerating Integrated Care
Mental Health
Bottom Line
View on ClinicalTrials.gov: NCT04092777 ↗Enrolled (actual)
1,044
Serious AEs
0.7%
Results posted
Aug 2025
Primary outcome: Primary: Engagement in Mental Health Intervention Sessions — 464 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Strong Minds (Behavioral); Enhanced Usual Care (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Nov 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Engagement in Mental Health Intervention Sessions |
464 | — |
| PRIMARY Hopkins Symptoms Checklist-25; HSCL-25 (Change) |
1.65; 1.84; 1.61; 1.81; 1.64; 1.78 | — |
| PRIMARY Functioning: WHODAS 2.0 (Change) |
19.91; 21.42; 19.01; 21.50; 19.74; 21.46 | — |
| PRIMARY Perceptions of Care Outpatient Survey (PoC-OP) (Change) |
87.00; 74.44; 86.37; 77.72; 83.15; 76.71 | — |
| SECONDARY CAT-MH Depression (Change) |
39.06; 46.34; 37.99; 45.66; 39.74; 45.19 | — |
| SECONDARY CAT-MH Anxiety (Change) |
32.82; 40.06; 31.08; 39.61; 33.48; 37.70 | — |
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. 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).
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT04092777). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.