Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04092777 |
| Other study ID # |
2018P002918 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 30, 2019 |
| Est. completion date |
November 16, 2023 |
Study information
| Verified date |
February 2024 |
| Source |
Massachusetts General Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. 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).
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.
