Clinical trial NCT04524767: Depression Screening in Black Churches
Official title: Community Partnered Participatory Approach to Implement Depression Screening in Black Churches
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Depression
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2020-08-24
Enrollment: 504
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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).

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

Primary outcomes:
measure: Treatment Engagement
timeFrame: Measured at 3-months post-screening
measure: Treatment Engagement
timeFrame: Measured at 6-months post-screening
Secondary outcomes:
measure: Change in Depressive Severity
timeFrame: Measured at 3- and 6-months post-screening
measure: Change in Depressive Symptoms
timeFrame: Measured at 3- and 6-months post-screening
measure: Change in Mental Health-Related Quality of Life
timeFrame: Measured at 3- and 6-months post-screening
measure: Change in Anxiety Severity
timeFrame: Measured at 3- and 6-months post-screening
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Irving Medical Center Center
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Columbia University
name: Olajide Williams, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hankerson SH, Lee YA, Brawley DK, Braswell K, Wickramaratne PJ, Weissman MM. Screening for Depression in African-American Churches. Am J Prev Med. 2015 Oct;49(4):526-33. doi: 10.1016/j.amepre.2015.03.039. Epub 2015 Jul 29.
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citation: Wells KB, Jones L, Chung B, Dixon EL, Tang L, Gilmore J, Sherbourne C, Ngo VK, Ong MK, Stockdale S, Ramos E, Belin TR, Miranda J. Community-partnered cluster-randomized comparative effectiveness trial of community engagement and planning or resources for services to address depression disparities. J Gen Intern Med. 2013 Oct;28(10):1268-78. doi: 10.1007/s11606-013-2484-3. Epub 2013 May 7.
citation: Hankerson SH, Shelton R, Weissman M, Wells KB, Teresi J, Mallaiah J, Joshua A, Williams O. Study protocol for comparing Screening, Brief Intervention, and Referral to Treatment (SBIRT) to referral as usual for depression in African American churches. Trials. 2022 Jan 31;23(1):93. doi: 10.1186/s13063-021-05767-8.