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临床试验/NCT04524767
NCT04524767已完成不适用

Community Partnered Participatory Approach to Implement Depression Screening in Black Churches

Columbia University3 个研究点 分布在 1 个国家目标入组 505 人开始时间: 2021年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
505
试验地点
3
主要终点
Treatment Engagement

研究概览

简要总结

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.

详细描述

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).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Screening
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

研究组 & 干预措施

SBIRT

Experimental

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.

干预措施: SBIRT (Behavioral)

Referral As Usual

Active Comparator

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

干预措施: Referral as Usual (Behavioral)

结局指标

主要结局

Treatment Engagement

时间窗: 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

Treatment Engagement at 3-month Follow-up

时间窗: Measured at 3-months post-screening

Attendance 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-up

时间窗: Measured at 6-months post-screening for the prior 3 months

Attendance at a depression-related clinical visit for which the subject reported receiving information, referral, counseling, or medication for depression.

次要结局

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

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Olajide Williams

Vice Chair of the Department of Neurology

Columbia University

研究点 (3)

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