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Building Infrastructure for Community Capacity in Accelerating Integrated Care

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04092777
Recruitment Status : Recruiting
First Posted : September 17, 2019
Last Update Posted : September 17, 2019
University of North Carolina, Greensboro
Information provided by (Responsible Party):
Margarita Alegria, PhD, Massachusetts General Hospital

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).

Condition or disease Intervention/treatment Phase
Mental Health Behavioral: Strong Minds Other: Enhanced Usual Care Not Applicable

Detailed Description:

The investigators will test the STRONG MINDS intervention with adults who have moderate to severe symptoms of depression or anxiety, defined as 66+ on the CAT-MH for depression and/or 51+ on the CAT-MH for anxiety. CAT-MH benchmarks for depression are: <50=no depression; 50-65=mild; 66-75=moderate; and>75 =severe depression, and for anxiety are 35-50 = mild anxiety; 51-65 = moderate anxiety; and >65 severe anxiety. 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : August 30, 2019
Estimated Primary Completion Date : February 28, 2023
Estimated Study Completion Date : February 28, 2023

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 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.
Behavioral: 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.

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.
Other: 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.

Primary Outcome Measures :
  1. Engagement in MH (change) [ Time Frame: Baseline, 3 months, 6 months, and 12 months after baseline ]
    At baseline: attendance at behavioral health visits in the previous 6 months. After baseline: attendance at 2 or more sessions of STRONG MINDS.

  2. Hopkins Symptoms Checklist-25 (change) [ Time Frame: Baseline, 3 months, 6 months, and 12 months after baseline ]
    First 10 questions on anxiety, second 15 on depression. @ = .90, .91, .92 and .95 for the English, Spanish, Mandarin and Cantonese versions, respectively.

  3. Functioning: WHODAS 2.0 (change) [ Time Frame: Baseline, 3 months, 6 months, and 12 months after baseline ]
    WHODAS 2.0: global measure of functioning. Internal consistency for Spanish version: @ =.86; English, Mandarin and Cantonese speakers: @ = .84, .81, .83, respectively.

  4. Perceptions of Care (PoC) Survey, outpatient version (change) [ Time Frame: Baseline, 3 months, 6 months, and 12 months after baseline ]
    18-item scale, focused on patients' perception of quality of care

Secondary Outcome Measures :
  1. CAT-MH (including CAT-SA for substance) (change) [ Time Frame: Baseline, 3 months, 6 months, and 12 months after baseline ]
    Computerized Adaptive Testing module for symptoms and estimation of severity of mental health and substance use items

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04092777

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Contact: Margarita Alegria, Ph.D 617-724-1237
Contact: Sheri Markle, MIA 617-724-1237

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United States, Massachusetts
South Cove Community Health Center Recruiting
Quincy, Massachusetts, United States, 02171
Contact: Albert Yeung         
MGH Broadway Primary Care - Revere Recruiting
Revere, Massachusetts, United States, 02151
Contact: Kerri Pagliuca         
Sponsors and Collaborators
Massachusetts General Hospital
University of North Carolina, Greensboro
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Principal Investigator: Margarita Alegria, Ph.D. Massachusetts General Hospital
Principal Investigator: Gabriela Livas Stein, Ph.D. University of North Carolina, Greensboro

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Responsible Party: Margarita Alegria, PhD, Chief, Disparities Research Unit, Massachusetts General Hospital Identifier: NCT04092777    
Other Study ID Numbers: 2018P002918
First Posted: September 17, 2019    Key Record Dates
Last Update Posted: September 17, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Margarita Alegria, PhD, Massachusetts General Hospital: