Depression
Conditions
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).
Interventions
Screening Brief Intervention and Referral to Treatment (SBIRT) is an evidence-based approach designed to provide screening, brief intervention, and referral to more intensive treatment for people at risk of developing mental disorders, including depression. SBIRT is composed of three core components: screening with a validated instrument, brief intervention, referral to treatment. Motivational Interviewing (MI) is the brief intervention most commonly used in SBIRT. MI is an empirically tested, person-centered, behavior change intervention designed to guide, elicit, and strengthen motivation for change. Subjects enrolled in the experimental SBIRT arm will receive up to a maximum of six sessions of MI.
We will utilize depression educational brochures describing the nine hallmark symptoms of depression symptoms and the importance of seeking treatment from pamphlets from the National Institute of Mental Health (NIMH). Subjects will also receive a list of referral sites in the study's catchment area of Upper Manhattan
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Engagement at 3-month Follow-up | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Depressive Severity | Baseline and 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, where a higher score indicates more severe depression. |
| Change in Depressive Symptoms | Baseline and 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. The NIH PROMIS-Depression Scale uses a T-score metric with a mean of 50 and a standard deviation of 10, based on the U.S. general population. Each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in raw score from 8 to 40 with higher scores indicating greater severity of depression. Raw scores are converted to T-scores, which allow comparison to the general population. A higher T-score indicates greater severity of depression. |
| Change in Mental Health-Related Quality of Life | Baseline and 3- and 6-months post-screening | This outcome is assessed by the Mental Health Component Summary Score of the 12-Item Medical Outcomes Study Short-Form (SF-12), where a higher score indicates fewer mental problems. The SF-12 is a commonly used measure of functioning, with a standardized mean score of 50 and standard deviation of 10. A norm-based score above 50 is better than average, while a score below 50 suggests lower than average mental health status. |
Countries
United States
Contacts
Columbia University
Icahn School of Medicine at Mount Sinai
Participant flow
Pre-assignment details
Community Health Workers were not considered Enrolled in this study.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Customized 18 - 64 years | 388 Participants |
| Age, Customized < 18 years | 0 Participants |
| Age, Customized > 64 years | 116 Participants |
| Education Completed Associate's degree | 48 Participants |
| Education Completed Bachelor's and Master's degree | 78 Participants |
| Education Completed Bachelor's degree | 45 Participants |
| Education Doctoral study | 8 Participants |
| Education Graduated high school (12 years) | 76 Participants |
| Education Less than 12 years | 23 Participants |
| Education Not specified | 19 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 9 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 265 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 20 Participants |
| Marital Status Married or living with someone as though married | 81 Participants |
| Marital Status Never married | 111 Participants |
| Marital Status Not specified | 11 Participants |
| Marital Status Separated or divorced | 66 Participants |
| Marital Status Widowed | 26 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 252 Participants |
| Race (NIH/OMB) More than one race | 26 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 10 Participants |
| Race (NIH/OMB) White | 2 Participants |
| Region of Enrollment United States | 210 participants |
| Sex: Female, Male Female | 247 Participants |
| Sex: Female, Male Male | 39 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 210 | 0 / 295 |
| other Total, other adverse events | 0 / 210 | 0 / 295 |
| serious Total, serious adverse events | 0 / 210 | 0 / 295 |