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Depression Screening in Black Churches

Community Partnered Participatory Approach to Implement Depression Screening in Black Churches

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04524767
Enrollment
505
Registered
2020-08-24
Start date
2021-08-01
Completion date
2025-07-18
Last updated
2026-07-28

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

Conditions

Depression

Brief summary

The overall aim of this study is to employ Community Health Workers (CHWs) to screen for depression in 30 Black churches and compare the effectiveness of Screening, Brief Intervention, and Referral to Treatment (SBIRT) (Intervention arm) to Referral As Usual (Control arm) on treatment engagement for depression. The investigators will assess patient-level outcomes (Mental-Health Related Quality of Life and depressive symptoms) at 3- and 6-months post-screening and conduct a mixed-methods process evaluation to assess multi-level facilitators and barriers of screening uptake.

Detailed description

African American adults (AAs), compared to White adults, are half as likely to be screened for depression in primary care settings. Disparities in depression screening contribute to poor clinical outcomes, as AAs with depression are more disabled, sicker longer, and less likely to seek treatment compared to Whites. Black churches are trusted settings that provide "de facto" mental health services for depression. Indeed, in the first study of its kind, the study team found that 20% of adults in Black churches screened positive for depression using the Patient Health Questionnaire-9 (PHQ-9). However, no subjects with a positive screen (PHQ-9 ≥10) accepted a treatment referral when offered by research coordinators onsite for each screening. Community Health Workers (CHWs), who are trusted para-professionals from the target community, may bridge the gap between depression screening and treatment. The investigators have trained and certified 102 CHWs from 42 Black churches in Harlem, New York to deliver an evidence-based intervention called Screening, Brief Intervention, and Referral to Treatment (SBIRT), which is centered on culturally tailored Motivational Interviewing (MI). Thus, the scientific premise of this study is that employing CHWs to implement depression screening in Black churches will bridge the gap between church-based depression-screening and engagement with clinical services. Using a Hybrid Type 1 Effectiveness-Implementation design, the investigators propose a 2-arm, mixed-methods Cluster-Randomized Controlled Trial within 30 Black churches our CHWs currently attend. Based on our pilot data, the investigators expect 20% of adults (n=600) to have a positive depression screen. Adults will be randomized based on church study site to either SBIRT (n=15 churches) or Referral As Usual (RAU, n=15 churches). The investigators will then compare the effectiveness of SBIRT (Intervention arm) to RAU (Usual Care arm) on treatment engagement (primary outcome), defined as attending a depression-related clinical visit for which the subject reported receiving information, referral, counseling, or medication for depression (Aim 1). The investigators will then compare changes in Mental Health Related Quality of Life and depressive symptoms (secondary outcomes) at 3- and 6-months post-screening (Aim 2). Finally, the investigators will conduct a concurrent, mixed-methods (qualitative-quantitative) process evaluation to assess contextual facilitators and barriers of screening and referral (Aim 3).

Interventions

BEHAVIORALSBIRT

Screening Brief Intervention and Referral to Treatment (SBIRT) is an evidence-based approach designed to provide screening, brief intervention, and referral to more intensive treatment for people at risk of developing mental disorders, including depression. SBIRT is composed of three core components: screening with a validated instrument, brief intervention, referral to treatment. Motivational Interviewing (MI) is the brief intervention most commonly used in SBIRT. MI is an empirically tested, person-centered, behavior change intervention designed to guide, elicit, and strengthen motivation for change. Subjects enrolled in the experimental SBIRT arm will receive up to a maximum of six sessions of MI.

BEHAVIORALReferral as Usual

We will utilize depression educational brochures describing the nine hallmark symptoms of depression symptoms and the importance of seeking treatment from pamphlets from the National Institute of Mental Health (NIMH). Subjects will also receive a list of referral sites in the study's catchment area of Upper Manhattan

Sponsors

Columbia University
Lead SponsorOTHER
National Institute of Mental Health (NIMH)
CollaboratorNIH

Study design

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

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Adults 18 years and older * Fluent in English * Patient Health Questionnaire-9 score and/or Generalized Anxiety Disorder-7 ≥ 10

Exclusion criteria

* Reporting active suicidality, or verbally endorsing homicidal ideation or psychotic symptoms * Currently receiving formal mental health treatment

Design outcomes

Primary

MeasureTime frameDescription
Treatment Engagement at 3-month Follow-upMeasured at 3-months post-screeningAttendance at a depression-related clinical visit for which the subject reported receiving information, referral, counseling, or medication for depression.
Treatment Engagement at 6-month Follow-upMeasured at 6-months post-screening for the prior 3 monthsAttendance at a depression-related clinical visit for which the subject reported receiving information, referral, counseling, or medication for depression.

Secondary

MeasureTime frameDescription
Change in Depressive SeverityBaseline 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.
Change in Depressive SymptomsBaseline 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.
Change in Mental Health-Related Quality of LifeBaseline 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.

Countries

United States

Contacts

STUDY_CHAIROlajide Williams, MD, MS

Columbia University

PRINCIPAL_INVESTIGATORSidney Hankerson, MD, MBA

Icahn School of Medicine at Mount Sinai

Participant flow

Pre-assignment details

Community Health Workers were not considered Enrolled in this study.

Baseline characteristics

Characteristic
Age, Customized
18 - 64 years
388 Participants
Age, Customized
< 18 years
0 Participants
Age, Customized
> 64 years
116 Participants
Education
Completed Associate's degree
48 Participants
Education
Completed Bachelor's and Master's degree
78 Participants
Education
Completed Bachelor's degree
45 Participants
Education
Doctoral study
8 Participants
Education
Graduated high school (12 years)
76 Participants
Education
Less than 12 years
23 Participants
Education
Not specified
19 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
9 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
265 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
20 Participants
Marital Status
Married or living with someone as though married
81 Participants
Marital Status
Never married
111 Participants
Marital Status
Not specified
11 Participants
Marital Status
Separated or divorced
66 Participants
Marital Status
Widowed
26 Participants
Race (NIH/OMB)
American Indian or Alaska Native
2 Participants
Race (NIH/OMB)
Asian
1 Participants
Race (NIH/OMB)
Black or African American
252 Participants
Race (NIH/OMB)
More than one race
26 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
1 Participants
Race (NIH/OMB)
Unknown or Not Reported
10 Participants
Race (NIH/OMB)
White
2 Participants
Region of Enrollment
United States
210 participants
Sex: Female, Male
Female
247 Participants
Sex: Female, Male
Male
39 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 2100 / 295
other
Total, other adverse events
0 / 2100 / 295
serious
Total, serious adverse events
0 / 2100 / 295

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 29, 2026