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.|
|ClinicalTrials.gov Identifier: NCT04092777|
Recruitment Status : Recruiting
First Posted : September 17, 2019
Last Update Posted : September 17, 2019
|Condition or disease||Intervention/treatment||Phase|
|Mental Health||Behavioral: Strong Minds Other: Enhanced Usual Care||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
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.
- 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.
- 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.
- 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.
- 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
- 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
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 ClinicalTrials.gov identifier (NCT number): NCT04092777
|Contact: Margarita Alegria, Ph.Dfirstname.lastname@example.org|
|Contact: Sheri Markle, MIA||617-724-1237||smarkle@Mgh.harvard.edu|
|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|
|Principal Investigator:||Margarita Alegria, Ph.D.||Massachusetts General Hospital|
|Principal Investigator:||Gabriela Livas Stein, Ph.D.||University of North Carolina, Greensboro|