Building Infrastructure for Community Capacity in Accelerating Integrated Care

NCT04092777 | Completed Results

• 1 other identifier: 2018P002918
• Study Type: interventional
• Target: 1,044
• Locations: 1 country
• Sites: 2

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).

Conditions

Mental Health

Keywords

ACOs; Medicaid; Racial; Ethnic; Linguistic; Minorities

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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'.

  Baseline, 3 months, 6 months, and 12 months after baseline

Secondary Outcomes (2)

• CAT-MH Depression (Change)

  Baseline, 3 months, 6 months, and 12 months after baseline

• CAT-MH Anxiety (Change)

  Baseline, 3 months, 6 months, and 12 months after baseline

Study Arms (2)

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.

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.

Other: Enhanced Usual Care

Interventions

Strong Minds 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.

Strong Minds Program

Enhanced Usual Care 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.

Enhanced Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• University of North Carolina, Greensboro: collaborator

Study Sites (2)

South Cove Community Health Center

Quincy, Massachusetts, 02171, United States

Location

MGH Broadway Primary Care - Revere

Revere, Massachusetts, 02151, United States

Location

Related Publications (1)

• 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.

  PMID: 40849140 DERIVED

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Limitations and Caveats

The study was concluded as planned and no technical problems with measurement were experienced.

Results Point of Contact

• Title: Dr. Margarita Alegria
• Organization: Massachusetts General Hospital

malegria@mgh.harvard.edu

617-724-1237

Study Officials

• Margarita Alegria, Ph.D.

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

• Gabriela Livas Stein, Ph.D.

  University of North Carolina, Greensboro

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Disparities Research Unit

Study Record Dates

• First Submitted: August 14, 2019
• First Posted: September 17, 2019
• Study Start: August 30, 2019
• Primary Completion: November 16, 2023
• Study Completion: November 16, 2023
• Last Updated: August 26, 2025
• Results First Posted: August 26, 2025

Record last verified: 2025-08

Locations

US (2)