Trial Outcomes & Findings for Building Infrastructure for Community Capacity in Accelerating Integrated Care (NCT NCT04092777)
NCT ID: NCT04092777
Last Updated: 2025-08-26
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
1044 participants
Primary outcome timeframe
6 months after baseline
Results posted on
2025-08-26
Participant Flow
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.
No significant events in the study occurred after participant enrollment.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
524
|
520
|
|
Overall Study
COMPLETED
|
488
|
469
|
|
Overall Study
NOT COMPLETED
|
36
|
51
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
28
|
46
|
|
Overall Study
Withdrawal by Subject
|
8
|
5
|
Baseline Characteristics
Building Infrastructure for Community Capacity in Accelerating Integrated Care
Baseline characteristics by cohort
| Measure |
Strong Minds Program
n=524 Participants
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.
|
Enhanced Usual Care
n=520 Participants
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.
|
Total
n=1044 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
42.4 years
STANDARD_DEVIATION 13.2 • n=5 Participants
|
42.8 years
STANDARD_DEVIATION 13.4 • n=7 Participants
|
42.6 years
STANDARD_DEVIATION 13.3 • n=5 Participants
|
|
Sex/Gender, Customized
Gender · Male
|
77 Participants
n=5 Participants
|
88 Participants
n=7 Participants
|
165 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Gender · Female
|
446 Participants
n=5 Participants
|
429 Participants
n=7 Participants
|
875 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Gender · Other
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race and ethnicity · Non-Latino White
|
46 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
92 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race and ethnicity · Non-Latino Black
|
69 Participants
n=5 Participants
|
80 Participants
n=7 Participants
|
149 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race and ethnicity · American Indian
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race and ethnicity · Non-Latino Asian
|
69 Participants
n=5 Participants
|
68 Participants
n=7 Participants
|
137 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race and ethnicity · Latino
|
332 Participants
n=5 Participants
|
322 Participants
n=7 Participants
|
654 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race and ethnicity · Mixed
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race and ethnicity · Other
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States · Massachusetts
|
263 Participants
n=5 Participants
|
259 Participants
n=7 Participants
|
522 Participants
n=5 Participants
|
|
Region of Enrollment
United States · North Carolina
|
261 Participants
n=5 Participants
|
261 Participants
n=7 Participants
|
522 Participants
n=5 Participants
|
|
Hopkins Symptom Checklist-25 (HSCL-25)
|
2.1 units on a scale
STANDARD_DEVIATION .5 • n=5 Participants
|
2.1 units on a scale
STANDARD_DEVIATION .5 • n=7 Participants
|
2.1 units on a scale
STANDARD_DEVIATION .5 • n=5 Participants
|
|
World Health Organization Disability Assessment Schedule 2.0
|
23.8 units on a scale
STANDARD_DEVIATION 8.9 • n=5 Participants
|
23.3 units on a scale
STANDARD_DEVIATION 8.6 • n=7 Participants
|
23.5 units on a scale
STANDARD_DEVIATION 8.8 • n=5 Participants
|
PRIMARY outcome
Timeframe: 6 months after baselinePopulation: Analysis followed intent-to-treat principles and included all randomized participants.
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.
Outcome measures
| Measure |
Strong Minds Program
n=524 Participants
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.
|
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.
|
|---|---|---|
|
Engagement in Mental Health Intervention Sessions
|
464 Participants
|
—
|
PRIMARY outcome
Timeframe: Baseline, 3 months, 6 months, and 12 months after baselinePopulation: Analysis followed intent-to-treat principles and included all randomized participants.
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.
Outcome measures
| Measure |
Strong Minds Program
n=524 Participants
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.
|
Enhanced Usual Care
n=520 Participants
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.
|
|---|---|---|
|
Hopkins Symptoms Checklist-25; HSCL-25 (Change)
Scores at month 3 adjusted for baseline scores
|
1.65 score on a scale
Standard Error 0.02
|
1.84 score on a scale
Standard Error 0.02
|
|
Hopkins Symptoms Checklist-25; HSCL-25 (Change)
Scores at month 6 adjusted for baseline scores
|
1.61 score on a scale
Standard Error 0.02
|
1.81 score on a scale
Standard Error 0.02
|
|
Hopkins Symptoms Checklist-25; HSCL-25 (Change)
Scores at month 12 adjusted for baseline scores
|
1.64 score on a scale
Standard Error 0.02
|
1.78 score on a scale
Standard Error 0.02
|
PRIMARY outcome
Timeframe: Baseline, 3 months, 6 months, and 12 months after baselinePopulation: Analysis followed intent-to-treat principles and included all randomized participants.
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.
Outcome measures
| Measure |
Strong Minds Program
n=524 Participants
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.
|
Enhanced Usual Care
n=520 Participants
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.
|
|---|---|---|
|
Functioning: WHODAS 2.0 (Change)
Scores at 3 months adjusted for baseline scores
|
19.91 score on a scale
Standard Error 0.34
|
21.42 score on a scale
Standard Error 0.32
|
|
Functioning: WHODAS 2.0 (Change)
Scores at 6 months adjusted for baseline scores
|
19.01 score on a scale
Standard Error 0.36
|
21.50 score on a scale
Standard Error 0.35
|
|
Functioning: WHODAS 2.0 (Change)
Scores at 12 months adjusted for baseline scores
|
19.74 score on a scale
Standard Error 0.39
|
21.46 score on a scale
Standard Error 0.35
|
PRIMARY outcome
Timeframe: Baseline, 3 months, 6 months, and 12 months after baselinePopulation: Analysis followed intent-to-treat principles and included all randomized participants.
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'.
Outcome measures
| Measure |
Strong Minds Program
n=524 Participants
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.
|
Enhanced Usual Care
n=520 Participants
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.
|
|---|---|---|
|
Perceptions of Care Outpatient Survey (PoC-OP) (Change)
Scores at 3 months
|
87.00 score on a scale
Standard Error 1.02
|
74.44 score on a scale
Standard Error 1.02
|
|
Perceptions of Care Outpatient Survey (PoC-OP) (Change)
Scores at 6 months
|
86.37 score on a scale
Standard Error 1.11
|
77.72 score on a scale
Standard Error 0.93
|
|
Perceptions of Care Outpatient Survey (PoC-OP) (Change)
Scores at 12 months
|
83.15 score on a scale
Standard Error 0.98
|
76.71 score on a scale
Standard Error 1.00
|
SECONDARY outcome
Timeframe: Baseline, 3 months, 6 months, and 12 months after baselinePopulation: Analysis followed intent-to-treat principles and included all randomized participants.
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.
Outcome measures
| Measure |
Strong Minds Program
n=524 Participants
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.
|
Enhanced Usual Care
n=520 Participants
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.
|
|---|---|---|
|
CAT-MH Depression (Change)
Scores at month 3 adjusted for baseline scores
|
39.06 score on a scale
Standard Error 0.80
|
46.34 score on a scale
Standard Error 0.78
|
|
CAT-MH Depression (Change)
Scores at month 6 adjusted for baseline scores
|
37.99 score on a scale
Standard Error 0.90
|
45.66 score on a scale
Standard Error 0.85
|
|
CAT-MH Depression (Change)
Scores at month 12 adjusted for baseline scores
|
39.74 score on a scale
Standard Error 0.92
|
45.19 score on a scale
Standard Error 0.83
|
SECONDARY outcome
Timeframe: Baseline, 3 months, 6 months, and 12 months after baselinePopulation: Analysis followed intent-to-treat principles and included all randomized participants.
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.
Outcome measures
| Measure |
Strong Minds Program
n=524 Participants
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.
|
Enhanced Usual Care
n=520 Participants
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.
|
|---|---|---|
|
CAT-MH Anxiety (Change)
Scores at month 3 adjusted for baseline scores
|
32.82 score on a scale
Standard Error 0.93
|
40.06 score on a scale
Standard Error 0.85
|
|
CAT-MH Anxiety (Change)
Scores at month 6 adjusted for baseline scores
|
31.08 score on a scale
Standard Error 1.00
|
39.61 score on a scale
Standard Error 1.01
|
|
CAT-MH Anxiety (Change)
Scores at month 12 adjusted for baseline scores
|
33.48 score on a scale
Standard Error 0.96
|
37.70 score on a scale
Standard Error 0.97
|
Adverse Events
Strong Minds Program
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
Enhanced Usual Care
Serious events: 4 serious events
Other events: 0 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Strong Minds Program
n=524 participants at risk
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.
|
Enhanced Usual Care
n=520 participants at risk
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.
|
|---|---|---|
|
Psychiatric disorders
Report of a 5 (a suicide attempt) on the Paykel suicidality screener after enrollment
|
0.57%
3/524 • 12 months
We considered as an adverse event the report of a 5 (a suicide attempt) on the Paykel suicidality screener after enrollment. We also considered cases where a participant passed away during the trial.
|
0.77%
4/520 • 12 months
We considered as an adverse event the report of a 5 (a suicide attempt) on the Paykel suicidality screener after enrollment. We also considered cases where a participant passed away during the trial.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place