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Depression Screening in Black Churches

Primary Purpose

Depression

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SBIRT
Referral as Usual
Sponsored by
Columbia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Depression

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Columbia University Irving Medical Center CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

SBIRT

Referral As Usual

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

Change in Depressive Severity
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 Depressive Symptoms
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 Life
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 Anxiety Severity
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).

Full Information

First Posted
August 18, 2020
Last Updated
June 9, 2023
Sponsor
Columbia University
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT04524767
Brief Title
Depression Screening in Black Churches
Official Title
Community Partnered Participatory Approach to Implement Depression Screening in Black Churches
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2021 (Actual)
Primary Completion Date
May 31, 2025 (Anticipated)
Study Completion Date
May 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Columbia University
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SBIRT
Arm Type
Experimental
Arm Description
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.
Arm Title
Referral As Usual
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
SBIRT
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Referral as Usual
Intervention Description
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
Primary Outcome Measure Information:
Title
Treatment Engagement
Description
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
Time Frame
Measured at 3-months post-screening
Title
Treatment Engagement
Description
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
Time Frame
Measured at 6-months post-screening
Secondary Outcome Measure Information:
Title
Change in Depressive Severity
Description
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).
Time Frame
Measured at 3- and 6-months post-screening
Title
Change in Depressive Symptoms
Description
NIH PROMIS-Depression Scale. This 8-item assessment is a composite of depressive symptoms from the Patient-Reported Outcomes Measurement Information System.
Time Frame
Measured at 3- and 6-months post-screening
Title
Change in Mental Health-Related Quality of Life
Description
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.
Time Frame
Measured at 3- and 6-months post-screening
Title
Change in Anxiety Severity
Description
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).
Time Frame
Measured at 3- and 6-months post-screening

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sidney Hankerson, MD, MBA
Phone
212-659-5607
Email
Sidney.Hankerson@mountsinai.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sidney Hankerson, MD, MBA
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Olajide Williams, MD, MS
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia University Irving Medical Center Center
City
New York
State/Province
New York
ZIP/Postal Code
10027
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sidney Hankerson, MD, MBA
Email
Sidney.Hankerson@mountsinai.org
First Name & Middle Initial & Last Name & Degree
Olajide Williams, MD, MS
Email
ow11@cumc.columbia.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified data will be shared through submission of study findings to peer-reviewed journals. De-identified data will also be shared at community forums and academic conferences.
IPD Sharing Time Frame
Data will be available six months after publication in a peer-reviewed journal article.
IPD Sharing 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.
Citations:
PubMed Identifier
26232907
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.
Results Reference
background
PubMed Identifier
28074566
Citation
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.
Results Reference
background
PubMed Identifier
26843796
Citation
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.
Results Reference
background
PubMed Identifier
8628042
Citation
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.
Results Reference
background
PubMed Identifier
12946886
Citation
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. Erratum In: Biol Psychiatry. 2003 Sep 1;54(5):585.
Results Reference
background
PubMed Identifier
23649787
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. Erratum In: J Gen Intern Med. 2013 Nov;28(11):1534.
Results Reference
background
PubMed Identifier
35101100
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.
Results Reference
derived

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Depression Screening in Black Churches

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