Ignite Creation Date:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2026-01-02 @ 1:49 AM
Study NCT ID:
NCT04524767
Status:
COMPLETED
Last Update Posted:
2025-12-18
First Post:
2020-08-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Depression Screening in Black Churches
Sponsor:
Columbia University
Organization:
Study Overview
Official Title:
Community Partnered Participatory Approach to Implement Depression Screening in Black Churches
Status:
COMPLETED
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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).
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).
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 1R01MH121590-01A1 | NIH | None | https://reporter.nih.gov/quic… | View |