Clinical trial NCT04092777: Building Infrastructure for Community Capacity in Accelerating Integrated Care
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Health
Keywords: ACOs
Medicaid
Racial
Ethnic
Linguistic
Minorities
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: University of North Carolina, Greensboro
First posted: 2019-09-17
Enrollment: 1044
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Engagement in MH (change)
timeFrame: Baseline, 3 months, 6 months, and 12 months after baseline
measure: Hopkins Symptoms Checklist-25 (change)
timeFrame: Baseline, 3 months, 6 months, and 12 months after baseline
measure: Functioning: WHODAS 2.0 (change)
timeFrame: Baseline, 3 months, 6 months, and 12 months after baseline
measure: Perceptions of Care (PoC) Survey, outpatient version (change)
timeFrame: Baseline, 3 months, 6 months, and 12 months after baseline
Secondary outcomes:
measure: CAT-MH (including CAT-SA for substance) (change)
timeFrame: Baseline, 3 months, 6 months, and 12 months after baseline
Other outcomes:
Locations:
city: Quincy
country: United States
facility: South Cove Community Health Center
state: Massachusetts
city: Revere
country: United States
facility: MGH Broadway Primary Care - Revere
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Margarita Alegria, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of North Carolina, Greensboro
name: Gabriela Livas Stein, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: