Trial Outcomes & Findings for Depression Screening in Black Churches (NCT NCT04524767)
NCT ID: NCT04524767
Last Updated: 2026-07-28
Results Overview
Attendance at a depression-related clinical visit for which the subject reported receiving information, referral, counseling, or medication for depression.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
505 participants
Primary outcome timeframe
Measured at 3-months post-screening
Results posted on
2026-07-28
Participant Flow
Community Health Workers were not considered Enrolled in this study.
Unit of analysis: churches
Participant milestones
| Measure |
Referral As Usual (RAU)
Referral as Usual will involve distributing depression educational materials (e.g., from the National Institute of Mental Health) and contact information for treatment providers in our target community.
|
Screening Brief Intervention and Referral to Treatment (SBIRT)
SBIRT will involve screening with the Patient Health Questionnaire-9 (PHQ-9); brief intervention with Motivational Interviewing (MI); and referral to specialty treatment, as needed for subjects with persistent depressive symptoms.
|
|---|---|---|
|
Overall Study
STARTED
|
210 15
|
295 15
|
|
Overall Study
COMPLETED
|
210 15
|
295 15
|
|
Overall Study
NOT COMPLETED
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Age was not recorded from one participant in the SBIRT arm
Baseline characteristics by cohort
| Measure |
Referral As Usual (RAU)
n=210 Participants
Referral as Usual will involve distributing depression educational materials (e.g., from the National Institute of Mental Health) and contact information for treatment providers in our target community.
|
Screening Brief Intervention and Referral to Treatment (SBIRT)
n=295 Participants
SBIRT will involve screening with the Patient Health Questionnaire-9 (PHQ-9); brief intervention with Motivational Interviewing (MI); and referral to specialty treatment, as needed for subjects with persistent depressive symptoms.
|
Total
n=505 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
< 18 years
|
0 Participants
n=210 Participants • Age was not recorded from one participant in the SBIRT arm
|
0 Participants
n=294 Participants • Age was not recorded from one participant in the SBIRT arm
|
0 Participants
n=504 Participants • Age was not recorded from one participant in the SBIRT arm
|
|
Age, Customized
18 - 64 years
|
158 Participants
n=210 Participants • Age was not recorded from one participant in the SBIRT arm
|
230 Participants
n=294 Participants • Age was not recorded from one participant in the SBIRT arm
|
388 Participants
n=504 Participants • Age was not recorded from one participant in the SBIRT arm
|
|
Age, Customized
> 64 years
|
52 Participants
n=210 Participants • Age was not recorded from one participant in the SBIRT arm
|
64 Participants
n=294 Participants • Age was not recorded from one participant in the SBIRT arm
|
116 Participants
n=504 Participants • Age was not recorded from one participant in the SBIRT arm
|
|
Sex: Female, Male
Female
|
170 Participants
n=209 Participants • Gender was not recorded from one participant in the RAU arm.
|
247 Participants
n=295 Participants • Gender was not recorded from one participant in the RAU arm.
|
417 Participants
n=504 Participants • Gender was not recorded from one participant in the RAU arm.
|
|
Sex: Female, Male
Male
|
39 Participants
n=209 Participants • Gender was not recorded from one participant in the RAU arm.
|
48 Participants
n=295 Participants • Gender was not recorded from one participant in the RAU arm.
|
87 Participants
n=504 Participants • Gender was not recorded from one participant in the RAU arm.
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=210 Participants
|
19 Participants
n=295 Participants
|
28 Participants
n=505 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
192 Participants
n=210 Participants
|
265 Participants
n=295 Participants
|
457 Participants
n=505 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
9 Participants
n=210 Participants
|
11 Participants
n=295 Participants
|
20 Participants
n=505 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=210 Participants
|
2 Participants
n=295 Participants
|
5 Participants
n=505 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=210 Participants
|
1 Participants
n=295 Participants
|
2 Participants
n=505 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=210 Participants
|
0 Participants
n=295 Participants
|
1 Participants
n=505 Participants
|
|
Race (NIH/OMB)
Black or African American
|
183 Participants
n=210 Participants
|
252 Participants
n=295 Participants
|
435 Participants
n=505 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=210 Participants
|
4 Participants
n=295 Participants
|
6 Participants
n=505 Participants
|
|
Race (NIH/OMB)
More than one race
|
12 Participants
n=210 Participants
|
26 Participants
n=295 Participants
|
38 Participants
n=505 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=210 Participants
|
10 Participants
n=295 Participants
|
18 Participants
n=505 Participants
|
|
Region of Enrollment
United States
|
210 participants
n=210 Participants
|
295 participants
n=295 Participants
|
505 participants
n=505 Participants
|
|
Marital Status
Married or living with someone as though married
|
46 Participants
n=210 Participants
|
81 Participants
n=295 Participants
|
127 Participants
n=505 Participants
|
|
Marital Status
Separated or divorced
|
44 Participants
n=210 Participants
|
66 Participants
n=295 Participants
|
110 Participants
n=505 Participants
|
|
Marital Status
Widowed
|
22 Participants
n=210 Participants
|
26 Participants
n=295 Participants
|
48 Participants
n=505 Participants
|
|
Marital Status
Never married
|
86 Participants
n=210 Participants
|
111 Participants
n=295 Participants
|
197 Participants
n=505 Participants
|
|
Marital Status
Not specified
|
12 Participants
n=210 Participants
|
11 Participants
n=295 Participants
|
23 Participants
n=505 Participants
|
|
Education
Less than 12 years
|
23 Participants
n=210 Participants
|
10 Participants
n=295 Participants
|
33 Participants
n=505 Participants
|
|
Education
Graduated high school (12 years)
|
76 Participants
n=210 Participants
|
82 Participants
n=295 Participants
|
158 Participants
n=505 Participants
|
|
Education
Completed Associate's degree
|
26 Participants
n=210 Participants
|
48 Participants
n=295 Participants
|
74 Participants
n=505 Participants
|
|
Education
Completed Bachelor's degree
|
45 Participants
n=210 Participants
|
90 Participants
n=295 Participants
|
135 Participants
n=505 Participants
|
|
Education
Completed Bachelor's and Master's degree
|
28 Participants
n=210 Participants
|
50 Participants
n=295 Participants
|
78 Participants
n=505 Participants
|
|
Education
Doctoral study
|
2 Participants
n=210 Participants
|
6 Participants
n=295 Participants
|
8 Participants
n=505 Participants
|
|
Education
Not specified
|
10 Participants
n=210 Participants
|
9 Participants
n=295 Participants
|
19 Participants
n=505 Participants
|
PRIMARY outcome
Timeframe: Measured at 3-months post-screeningAttendance at a depression-related clinical visit for which the subject reported receiving information, referral, counseling, or medication for depression.
Outcome measures
| Measure |
Referral As Usual (RAU)
n=210 Participants
Referral as Usual will involve distributing depression educational materials (e.g., from the National Institute of Mental Health) and contact information for treatment providers in our target community.
|
Screening Brief Intervention and Referral to Treatment (SBIRT)
n=295 Participants
SBIRT will involve screening with the Patient Health Questionnaire-9 (PHQ-9); brief intervention with Motivational Interviewing (MI); and referral to specialty treatment, as needed for subjects with persistent depressive symptoms.
|
|---|---|---|
|
Treatment Engagement at 3-month Follow-up
|
23.3 percent of participants
|
35.0 percent of participants
|
PRIMARY outcome
Timeframe: Measured at 6-months post-screening for the prior 3 monthsPopulation: The respondents were asked whether they had a visit during the prior 3 months for which the subject reported receiving information, referral, counseling, or medication for depression. The numbers represent those that reported engagement at the 6-month assessment only (does not include the 3-month assessment information).
Attendance at a depression-related clinical visit for which the subject reported receiving information, referral, counseling, or medication for depression.
Outcome measures
| Measure |
Referral As Usual (RAU)
n=210 Participants
Referral as Usual will involve distributing depression educational materials (e.g., from the National Institute of Mental Health) and contact information for treatment providers in our target community.
|
Screening Brief Intervention and Referral to Treatment (SBIRT)
n=295 Participants
SBIRT will involve screening with the Patient Health Questionnaire-9 (PHQ-9); brief intervention with Motivational Interviewing (MI); and referral to specialty treatment, as needed for subjects with persistent depressive symptoms.
|
|---|---|---|
|
Treatment Engagement at 6-month Follow-up
|
23.9 percent of participants
|
27.9 percent of participants
|
SECONDARY outcome
Timeframe: Baseline and 3- and 6-months post-screening16-Item Quick Inventory of Depressive Symptomatology (QIDS-SR). The QIDS-SR is a validated self-report measure that assesses depressive severity. Scores range from 0 to 27, where a higher score indicates more severe depression.
Outcome measures
| Measure |
Referral As Usual (RAU)
n=210 Participants
Referral as Usual will involve distributing depression educational materials (e.g., from the National Institute of Mental Health) and contact information for treatment providers in our target community.
|
Screening Brief Intervention and Referral to Treatment (SBIRT)
n=295 Participants
SBIRT will involve screening with the Patient Health Questionnaire-9 (PHQ-9); brief intervention with Motivational Interviewing (MI); and referral to specialty treatment, as needed for subjects with persistent depressive symptoms.
|
|---|---|---|
|
Change in Depressive Severity
Baseline
|
8.77 score on a scale
Standard Deviation 4.86
|
9.52 score on a scale
Standard Deviation 4.51
|
|
Change in Depressive Severity
3-month follow-up
|
7.79 score on a scale
Standard Deviation 4.69
|
7.68 score on a scale
Standard Deviation 4.52
|
|
Change in Depressive Severity
6-month follow-up
|
6.76 score on a scale
Standard Deviation 3.98
|
7.72 score on a scale
Standard Deviation 4.12
|
SECONDARY outcome
Timeframe: Baseline and 3- and 6-months post-screeningNIH PROMIS-Depression Scale. This 8-item assessment is a composite of depressive symptoms from the Patient-Reported Outcomes Measurement Information System. The NIH PROMIS-Depression Scale uses a T-score metric with a mean of 50 and a standard deviation of 10, based on the U.S. general population. Each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in raw score from 8 to 40 with higher scores indicating greater severity of depression. Raw scores are converted to T-scores, which allow comparison to the general population. A higher T-score indicates greater severity of depression.
Outcome measures
| Measure |
Referral As Usual (RAU)
n=210 Participants
Referral as Usual will involve distributing depression educational materials (e.g., from the National Institute of Mental Health) and contact information for treatment providers in our target community.
|
Screening Brief Intervention and Referral to Treatment (SBIRT)
n=295 Participants
SBIRT will involve screening with the Patient Health Questionnaire-9 (PHQ-9); brief intervention with Motivational Interviewing (MI); and referral to specialty treatment, as needed for subjects with persistent depressive symptoms.
|
|---|---|---|
|
Change in Depressive Symptoms
Baseline
|
53.80 T-score
Standard Deviation 7.56
|
54.65 T-score
Standard Deviation 7.84
|
|
Change in Depressive Symptoms
3-month follow-up
|
52.27 T-score
Standard Deviation 7.90
|
52.71 T-score
Standard Deviation 7.26
|
|
Change in Depressive Symptoms
6-month follow-up
|
50.14 T-score
Standard Deviation 8.50
|
52.23 T-score
Standard Deviation 7.81
|
SECONDARY outcome
Timeframe: Baseline and 3- and 6-months post-screeningThis outcome is assessed by the Mental Health Component Summary Score of the 12-Item Medical Outcomes Study Short-Form (SF-12), where a higher score indicates fewer mental problems. The SF-12 is a commonly used measure of functioning, with a standardized mean score of 50 and standard deviation of 10. A norm-based score above 50 is better than average, while a score below 50 suggests lower than average mental health status.
Outcome measures
| Measure |
Referral As Usual (RAU)
n=210 Participants
Referral as Usual will involve distributing depression educational materials (e.g., from the National Institute of Mental Health) and contact information for treatment providers in our target community.
|
Screening Brief Intervention and Referral to Treatment (SBIRT)
n=295 Participants
SBIRT will involve screening with the Patient Health Questionnaire-9 (PHQ-9); brief intervention with Motivational Interviewing (MI); and referral to specialty treatment, as needed for subjects with persistent depressive symptoms.
|
|---|---|---|
|
Change in Mental Health-Related Quality of Life
Baseline
|
34.04 norm-based score
Standard Deviation 7.96
|
32.90 norm-based score
Standard Deviation 8.68
|
|
Change in Mental Health-Related Quality of Life
3-Month Follow-up
|
35.94 norm-based score
Standard Deviation 9.74
|
36.49 norm-based score
Standard Deviation 7.50
|
|
Change in Mental Health-Related Quality of Life
6-Month Follow-up
|
38.31 norm-based score
Standard Deviation 7.82
|
37.56 norm-based score
Standard Deviation 8.09
|
Adverse Events
Referral As Usual (RAU)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Screening Brief Intervention and Referral to Treatment (SBIRT)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place