Building Infrastructure for Community Capacity in Accelerating Integrated Care

NCT ID: NCT04092777

Last Updated: 2025-08-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1044 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-30
• Study Completion Date: 2023-11-16

Brief 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).

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Strong Minds Program

This is a 10-session, culturally-adapted intervention, that includes cognitive behavioral therapy techniques combined with mindfulness exercises, led by a Community Health Worker.

Group Type: EXPERIMENTAL

Strong Minds

Intervention Type: BEHAVIORAL

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 Care

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.

Group Type: OTHER

Enhanced Usual Care

Intervention Type: OTHER

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.

Interventions

Strong Minds

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.

Intervention Type: BEHAVIORAL

Enhanced Usual Care

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of North Carolina, Greensboro

OTHER

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Margarita Alegria, PhD

Chief, Disparities Research Unit

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Margarita Alegria, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Gabriela Livas Stein, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Greensboro

Locations

South Cove Community Health Center

Quincy, Massachusetts, United States

MGH Broadway Primary Care - Revere

Revere, Massachusetts, United States

Countries

United States

References

Alegria 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.

Reference Type: DERIVED

PMID: 40849140 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2018P002918

Identifier Type: -

Identifier Source: org_study_id