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Depression Screening in Black Churches

Not Applicable
Recruiting
Conditions
Depression
Interventions
Behavioral: SBIRT
Behavioral: Referral as Usual
Registration Number
NCT04524767
Lead Sponsor
Columbia University
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).

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
600
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
SBIRTSBIRTSBIRT 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.
Referral As UsualReferral as UsualReferral 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
Primary Outcome Measures
NameTimeMethod
Treatment EngagementMeasured 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 Outcome Measures
NameTimeMethod
Change in Depressive SymptomsMeasured at 3- and 6-months post-screening

NIH PROMIS-Depression Scale. This 8-item assessment is a composite of depressive symptoms from the Patient-Reported Outcomes Measurement Information System.

Change in Mental Health-Related Quality of LifeMeasured at 3- and 6-months post-screening

The Mental Health Component Summary Score of the 12-Item Medical Outcomes Study Short-Form (SF-12). The SF-12 is a commonly used measure of functioning, with standardized mean score of 50 and standard deviation of 10.

Change in Depressive SeverityMeasured at 3- and 6-months post-screening

16-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 (worse outcome).

Change in Anxiety SeverityMeasured at 3- and 6-months post-screening

Generalized Anxiety Disorder-7 (GAD-7). The GAD-7 is a self-report measure that assesses anxiety symptoms. Scores range from 0 to 21 (worse outcome).

Trial Locations

Locations (1)

Columbia University Irving Medical Center Center

🇺🇸

New York, New York, United States

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