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Building Infrastructure for Community Capacity in Accelerating Integrated Care

1/2 Building Infrastructure for Community Capacity in Accelerating Integrated Care and 2/2 Building Infrastructure for Community Capacity in Accelerating Integrated Care

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04092777
Enrollment
1044
Registered
2019-09-17
Start date
2019-08-30
Completion date
2023-11-16
Last updated
2025-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mental Health

Keywords

ACOs, Medicaid, Racial, Ethnic, Linguistic, Minorities

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.

Interventions

BEHAVIORALStrong 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.

OTHEREnhanced 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.

Sponsors

University of North Carolina, Greensboro
CollaboratorOTHER
Massachusetts General Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frameDescription
Engagement in Mental Health Intervention Sessions6 months after baselineEngagement 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.
Hopkins Symptoms Checklist-25; HSCL-25 (Change)Baseline, 3 months, 6 months, and 12 months after baselineThe 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.
Functioning: WHODAS 2.0 (Change)Baseline, 3 months, 6 months, and 12 months after baselineThe 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.
Perceptions of Care Outpatient Survey (PoC-OP) (Change)Baseline, 3 months, 6 months, and 12 months after baselinePerceived 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'.

Secondary

MeasureTime frameDescription
CAT-MH Depression (Change)Baseline, 3 months, 6 months, and 12 months after baselineComputerized Adaptive Test for Mental Health (CAT-MH), is a suite of validated computer adaptive tests. CAT-MH scores are based on responses to algorithm-selected items that minimize participant burden using item response theory methodology. The adaptive nature of the CAT-MH targets a participant's specific level of severity at that point in time. The number of items at each time point varies because the same questions are not repeatedly administered. The depression subscale assesses severity of depressive symptoms. Total scores range from 0 to 100 with higher scores indicating worse depression symptoms.
CAT-MH Anxiety (Change)Baseline, 3 months, 6 months, and 12 months after baselineComputerized Adaptive Test for Mental Health (CAT-MH), is a suite of validated computer adaptive tests. CAT-MH scores are based on responses to algorithm-selected items that minimize participant burden using item response theory methodology. The adaptive nature of the CAT-MH targets a participant's specific level of severity at that point in time. The number of items at each time point varies because the same questions are not repeatedly administered. The anxiety subscale assesses severity of anxiety symptoms. Total scores range from 0 to 100 with higher scores indicating worse anxiety symptoms.

Countries

United States

Participant flow

Recruitment details

Staff recruited participants from 20 community based organizations and 17 clinics serving a high proportion of clients who identify as Latino (primarily Spanish speaking), Asian (mainly Mandarin or Cantonese speaking), or Black (primarily English speaking). Half of the participants were recruited in North Carolina and half in Massachusetts. From September 4, 2019, to March 2, 2023, research staff assessed 2,584 potential participants for eligibility.

Pre-assignment details

No significant events in the study occurred after participant enrollment.

Participants by arm

ArmCount
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. 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.
524
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. 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.
520
Total1,044

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLost to Follow-up2846
Overall StudyWithdrawal by Subject85

Baseline characteristics

CharacteristicTotalStrong Minds ProgramEnhanced Usual Care
Age, Continuous42.6 years
STANDARD_DEVIATION 13.3
42.4 years
STANDARD_DEVIATION 13.2
42.8 years
STANDARD_DEVIATION 13.4
Hopkins Symptom Checklist-25 (HSCL-25)2.1 units on a scale
STANDARD_DEVIATION 0.5
2.1 units on a scale
STANDARD_DEVIATION 0.5
2.1 units on a scale
STANDARD_DEVIATION 0.5
Race/Ethnicity, Customized
Race and ethnicity
American Indian
3 Participants2 Participants1 Participants
Race/Ethnicity, Customized
Race and ethnicity
Latino
654 Participants332 Participants322 Participants
Race/Ethnicity, Customized
Race and ethnicity
Mixed
7 Participants4 Participants3 Participants
Race/Ethnicity, Customized
Race and ethnicity
Non-Latino Asian
137 Participants69 Participants68 Participants
Race/Ethnicity, Customized
Race and ethnicity
Non-Latino Black
149 Participants69 Participants80 Participants
Race/Ethnicity, Customized
Race and ethnicity
Non-Latino White
92 Participants46 Participants46 Participants
Race/Ethnicity, Customized
Race and ethnicity
Other
2 Participants2 Participants0 Participants
Region of Enrollment
United States
Massachusetts
522 Participants263 Participants259 Participants
Region of Enrollment
United States
North Carolina
522 Participants261 Participants261 Participants
Sex/Gender, Customized
Gender
Female
875 Participants446 Participants429 Participants
Sex/Gender, Customized
Gender
Male
165 Participants77 Participants88 Participants
Sex/Gender, Customized
Gender
Other
4 Participants1 Participants3 Participants
World Health Organization Disability Assessment Schedule 2.023.5 units on a scale
STANDARD_DEVIATION 8.8
23.8 units on a scale
STANDARD_DEVIATION 8.9
23.3 units on a scale
STANDARD_DEVIATION 8.6

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 5242 / 520
other
Total, other adverse events
0 / 5240 / 520
serious
Total, serious adverse events
3 / 5244 / 520

Outcome results

Primary

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.

Time frame: 6 months after baseline

Population: Analysis followed intent-to-treat principles and included all randomized participants.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Strong Minds ProgramEngagement in Mental Health Intervention Sessions464 Participants
Primary

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.

Time frame: Baseline, 3 months, 6 months, and 12 months after baseline

Population: Analysis followed intent-to-treat principles and included all randomized participants.

ArmMeasureGroupValue (LEAST_SQUARES_MEAN)Dispersion
Strong Minds ProgramFunctioning: WHODAS 2.0 (Change)Scores at 3 months adjusted for baseline scores19.91 score on a scaleStandard Error 0.34
Strong Minds ProgramFunctioning: WHODAS 2.0 (Change)Scores at 6 months adjusted for baseline scores19.01 score on a scaleStandard Error 0.36
Strong Minds ProgramFunctioning: WHODAS 2.0 (Change)Scores at 12 months adjusted for baseline scores19.74 score on a scaleStandard Error 0.39
Enhanced Usual CareFunctioning: WHODAS 2.0 (Change)Scores at 3 months adjusted for baseline scores21.42 score on a scaleStandard Error 0.32
Enhanced Usual CareFunctioning: WHODAS 2.0 (Change)Scores at 6 months adjusted for baseline scores21.50 score on a scaleStandard Error 0.35
Enhanced Usual CareFunctioning: WHODAS 2.0 (Change)Scores at 12 months adjusted for baseline scores21.46 score on a scaleStandard Error 0.35
Primary

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.

Time frame: Baseline, 3 months, 6 months, and 12 months after baseline

Population: Analysis followed intent-to-treat principles and included all randomized participants.

ArmMeasureGroupValue (LEAST_SQUARES_MEAN)Dispersion
Strong Minds ProgramHopkins Symptoms Checklist-25; HSCL-25 (Change)Scores at month 3 adjusted for baseline scores1.65 score on a scaleStandard Error 0.02
Strong Minds ProgramHopkins Symptoms Checklist-25; HSCL-25 (Change)Scores at month 6 adjusted for baseline scores1.61 score on a scaleStandard Error 0.02
Strong Minds ProgramHopkins Symptoms Checklist-25; HSCL-25 (Change)Scores at month 12 adjusted for baseline scores1.64 score on a scaleStandard Error 0.02
Enhanced Usual CareHopkins Symptoms Checklist-25; HSCL-25 (Change)Scores at month 3 adjusted for baseline scores1.84 score on a scaleStandard Error 0.02
Enhanced Usual CareHopkins Symptoms Checklist-25; HSCL-25 (Change)Scores at month 6 adjusted for baseline scores1.81 score on a scaleStandard Error 0.02
Enhanced Usual CareHopkins Symptoms Checklist-25; HSCL-25 (Change)Scores at month 12 adjusted for baseline scores1.78 score on a scaleStandard Error 0.02
Primary

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'.

Time frame: Baseline, 3 months, 6 months, and 12 months after baseline

Population: Analysis followed intent-to-treat principles and included all randomized participants.

ArmMeasureGroupValue (LEAST_SQUARES_MEAN)Dispersion
Strong Minds ProgramPerceptions of Care Outpatient Survey (PoC-OP) (Change)Scores at 3 months87.00 score on a scaleStandard Error 1.02
Strong Minds ProgramPerceptions of Care Outpatient Survey (PoC-OP) (Change)Scores at 6 months86.37 score on a scaleStandard Error 1.11
Strong Minds ProgramPerceptions of Care Outpatient Survey (PoC-OP) (Change)Scores at 12 months83.15 score on a scaleStandard Error 0.98
Enhanced Usual CarePerceptions of Care Outpatient Survey (PoC-OP) (Change)Scores at 3 months74.44 score on a scaleStandard Error 1.02
Enhanced Usual CarePerceptions of Care Outpatient Survey (PoC-OP) (Change)Scores at 6 months77.72 score on a scaleStandard Error 0.93
Enhanced Usual CarePerceptions of Care Outpatient Survey (PoC-OP) (Change)Scores at 12 months76.71 score on a scaleStandard Error 1
Secondary

CAT-MH Anxiety (Change)

Computerized Adaptive Test for Mental Health (CAT-MH), is a suite of validated computer adaptive tests. CAT-MH scores are based on responses to algorithm-selected items that minimize participant burden using item response theory methodology. The adaptive nature of the CAT-MH targets a participant's specific level of severity at that point in time. The number of items at each time point varies because the same questions are not repeatedly administered. The anxiety subscale assesses severity of anxiety symptoms. Total scores range from 0 to 100 with higher scores indicating worse anxiety symptoms.

Time frame: Baseline, 3 months, 6 months, and 12 months after baseline

Population: Analysis followed intent-to-treat principles and included all randomized participants.

ArmMeasureGroupValue (LEAST_SQUARES_MEAN)Dispersion
Strong Minds ProgramCAT-MH Anxiety (Change)Scores at month 3 adjusted for baseline scores32.82 score on a scaleStandard Error 0.93
Strong Minds ProgramCAT-MH Anxiety (Change)Scores at month 6 adjusted for baseline scores31.08 score on a scaleStandard Error 1
Strong Minds ProgramCAT-MH Anxiety (Change)Scores at month 12 adjusted for baseline scores33.48 score on a scaleStandard Error 0.96
Enhanced Usual CareCAT-MH Anxiety (Change)Scores at month 3 adjusted for baseline scores40.06 score on a scaleStandard Error 0.85
Enhanced Usual CareCAT-MH Anxiety (Change)Scores at month 6 adjusted for baseline scores39.61 score on a scaleStandard Error 1.01
Enhanced Usual CareCAT-MH Anxiety (Change)Scores at month 12 adjusted for baseline scores37.70 score on a scaleStandard Error 0.97
Secondary

CAT-MH Depression (Change)

Computerized Adaptive Test for Mental Health (CAT-MH), is a suite of validated computer adaptive tests. CAT-MH scores are based on responses to algorithm-selected items that minimize participant burden using item response theory methodology. The adaptive nature of the CAT-MH targets a participant's specific level of severity at that point in time. The number of items at each time point varies because the same questions are not repeatedly administered. The depression subscale assesses severity of depressive symptoms. Total scores range from 0 to 100 with higher scores indicating worse depression symptoms.

Time frame: Baseline, 3 months, 6 months, and 12 months after baseline

Population: Analysis followed intent-to-treat principles and included all randomized participants.

ArmMeasureGroupValue (LEAST_SQUARES_MEAN)Dispersion
Strong Minds ProgramCAT-MH Depression (Change)Scores at month 3 adjusted for baseline scores39.06 score on a scaleStandard Error 0.8
Strong Minds ProgramCAT-MH Depression (Change)Scores at month 6 adjusted for baseline scores37.99 score on a scaleStandard Error 0.9
Strong Minds ProgramCAT-MH Depression (Change)Scores at month 12 adjusted for baseline scores39.74 score on a scaleStandard Error 0.92
Enhanced Usual CareCAT-MH Depression (Change)Scores at month 6 adjusted for baseline scores45.66 score on a scaleStandard Error 0.85
Enhanced Usual CareCAT-MH Depression (Change)Scores at month 3 adjusted for baseline scores46.34 score on a scaleStandard Error 0.78
Enhanced Usual CareCAT-MH Depression (Change)Scores at month 12 adjusted for baseline scores45.19 score on a scaleStandard Error 0.83

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026