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Clinical Trials/NCT04524767
NCT04524767
Completed
Not Applicable

Community Partnered Participatory Approach to Implement Depression Screening in Black Churches

Columbia University2 sites in 1 country505 target enrollmentAugust 1, 2021
ConditionsDepression

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Depression
Sponsor
Columbia University
Enrollment
505
Locations
2
Primary Endpoint
Treatment Engagement
Status
Completed
Last Updated
4 months ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
August 1, 2021
End Date
July 18, 2025
Last Updated
4 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Olajide Williams

Vice Chair of the Department of Neurology

Columbia University

Eligibility Criteria

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

Outcomes

Primary Outcomes

Treatment Engagement

Time Frame: Measured at 6-months post-screening

Attendance at a depression-related clinical visit for which the subject reported receiving information, referral, counseling, or medication for depression as assessed by the Community Partners in Care Health Services Use Scale

Secondary Outcomes

  • Change in Depressive Symptoms(Measured at 3- and 6-months post-screening)
  • Change in Mental Health-Related Quality of Life(Measured at 3- and 6-months post-screening)
  • Change in Depressive Severity(Measured at 3- and 6-months post-screening)
  • Change in Anxiety Severity(Measured at 3- and 6-months post-screening)

Study Sites (2)

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