Depression Screening in Black Churches

NCT04524767 | Completed

• 2 other identifiers: AAAT14741R01MH121590-01A1
• Study Type: interventional
• Target: 505
• Locations: 1 country
• Sites: 2

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.

Conditions

Depression

Outcome Measures

Primary Outcomes (2)

• Treatment Engagement

  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

  Measured at 3-months post-screening

• Treatment Engagement

  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

  Measured at 6-months post-screening

Secondary Outcomes (4)

• Change in Depressive Severity

  Measured at 3- and 6-months post-screening

• 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 Anxiety Severity

  Measured at 3- and 6-months post-screening

Study Arms (2)

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.

Behavioral: SBIRT

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

Behavioral: Referral as Usual

Interventions

SBIRT BEHAVIORAL

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.

SBIRT

Referral as Usual BEHAVIORAL

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

Referral As Usual

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Columbia University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (2)

Columbia University Irving Medical Center Center

New York, New York, 10027, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Related Publications (7)

• 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.

  PMID: 26232907 BACKGROUND

• Bray JW, Del Boca FK, McRee BG, Hayashi SW, Babor TF. Screening, Brief Intervention and Referral to Treatment (SBIRT): rationale, program overview and cross-site evaluation. Addiction. 2017 Feb;112 Suppl 2:3-11. doi: 10.1111/add.13676.

  PMID: 28074566 BACKGROUND

• Boutin-Foster C, Offidani E, Kanna B, Ogedegbe G, Ravenell J, Scott E, Rodriguez A, Ramos R, Michelen W, Gerber LM, Charlson M. Results from the Trial Using Motivational Interviewing, Positive Affect, and Self-Affirmation in African Americans with Hypertension (TRIUMPH). Ethn Dis. 2016 Jan 21;26(1):51-60. doi: 10.18865/ed.26.1.51.

  PMID: 26843796 BACKGROUND

• Ware J Jr, Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996 Mar;34(3):220-33. doi: 10.1097/00005650-199603000-00003.

  PMID: 8628042 BACKGROUND

• Rush AJ, Trivedi MH, Ibrahim HM, Carmody TJ, Arnow B, Klein DN, Markowitz JC, Ninan PT, Kornstein S, Manber R, Thase ME, Kocsis JH, Keller MB. The 16-Item Quick Inventory of Depressive Symptomatology (QIDS), clinician rating (QIDS-C), and self-report (QIDS-SR): a psychometric evaluation in patients with chronic major depression. Biol Psychiatry. 2003 Sep 1;54(5):573-83. doi: 10.1016/s0006-3223(02)01866-8.

  PMID: 12946886 BACKGROUND

• 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.

  PMID: 23649787 BACKGROUND

• 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.

  PMID: 35101100 DERIVED

MeSH Terms

Conditions

Depression

Interventions

Referral and Consultation

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Professional Practice; Organization and Administration; Health Services Administration

Study Officials

• Olajide Williams, MD, MS

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Chair of the Department of Neurology

Study Record Dates

• First Submitted: August 18, 2020
• First Posted: August 24, 2020
• Study Start: August 1, 2021
• Primary Completion: April 12, 2025
• Study Completion: July 18, 2025
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available six months after publication in a peer-reviewed journal article.
• Access Criteria: The study Co-Primary Investigators, Drs. Sidney Hankerson and Olajide Williams, will create criteria and review requests for data sharing access. Data will be available to analyze waht types of clinical and demographic factors impact study outcomes.

Locations

US (2)