DepressionNCT04524767
Depression Screening in Black Churches
A study testing SBIRT and Referral as Usual in people with Depression, run by Columbia University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depression
- What is being tested?
- SBIRT and Referral as Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 505 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Aug 2021to 18 Jul 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults 18 years and older
- Fluent in English
- Patient Health Questionnaire-9 score and/or Generalized Anxiety Disorder-7 ≥ 10
Who cannot join
- Reporting active suicidality, or verbally endorsing homicidal ideation or psychotic symptoms
- Currently receiving formal mental health treatment
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Columbia University Irving Medical Center Center
New York, New York, 10027
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
Official title: Community Partnered Participatory Approach to Implement Depression Screening in Black Churches
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.
Read the 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).
- Conditions
- Depression
- Being tested
- SBIRT, Referral as Usual
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SBIRTBehavioural
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.
Referral as UsualBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Behavioral: Referral as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Engagement at 3-month Follow-up
Attendance at a depression-related clinical visit for which the subject reported receiving information, referral, counseling, or medication for depression.
Measured: Measured at 3-months post-screening
Treatment Engagement at 6-month Follow-up
Attendance at a depression-related clinical visit for which the subject reported receiving information, referral, counseling, or medication for depression.
Measured: Measured at 6-months post-screening for the prior 3 months
Secondary outcomes (3)
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, where a higher score indicates more severe depression.
Measured: Baseline and 3- and 6-months post-screening
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. 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.
Measured: Baseline and 3- and 6-months post-screening
Change in Mental Health-Related Quality of Life
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.
Measured: Baseline and 3- and 6-months post-screening
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2020
- Study start1 Aug 2021
- Primary completion18 Jul 2025
- Study completion18 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 505 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Olajide Williams, Columbia University
- Investigators
- Olajide Williams, MD, MS, Study chair, Columbia UniversitySidney Hankerson, MD, MBA, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04524767
- Sponsor's protocol ID
- AAAT1474
- Other IDs
- 1R01MH121590-01A1
- Status last verified
- Jun 2026
- First submitted
- 18 Aug 2020
- Last updated
- 28 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 26232907Bray 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.
PubMed 28074566Boutin-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.
PubMed 26843796Ware 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.
PubMed 8628042Rush 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.
PubMed 12946886Wells 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.
PubMed 23649787Hankerson 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.
PubMed 35101100
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community Partnered Participatory Approach to Implement Depression Screening in Black Churches
- ClinicalTrials.gov ID
- NCT04524767
- Acronym / sponsor ID
- AAAT1474
- Conditions
- Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 505 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 18 Jul 2025 (actual)
- Study completion
- 18 Jul 2025 (actual)
- First posted
- 24 Aug 2020 (actual)
- Results
- Posted 28 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SBIRT | Experimental | Behavioral: SBIRTSBIRT 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 | Active comparator | Behavioral: Referral 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults 18 years and older
- Fluent in English
- Patient Health Questionnaire-9 score and/or Generalized Anxiety Disorder-7 ≥ 10
Key exclusion criteria (2 listed)
- Reporting active suicidality, or verbally endorsing homicidal ideation or psychotic symptoms
- Currently receiving formal mental health treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SBIRTScreening 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. | Behavioural | SBIRT |
| Referral as UsualWe 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 | Behavioural | Referral As Usual |
Primary outcome
Treatment Engagement at 3-month Follow-up
Time frame: 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
Time frame: 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.
3 secondary outcomes
Change in Depressive Severity
Time frame: Baseline and 3- and 6-months post-screening
Change in Depressive Symptoms
Time frame: Baseline and 3- and 6-months post-screening
Change in Mental Health-Related Quality of Life
Time frame: Baseline and 3- and 6-months post-screening
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 26232907Hankerson 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.
- Background: PubMed 28074566Bray 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.
- Background: PubMed 26843796Boutin-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.
- Background: PubMed 8628042Ware 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.
- Background: PubMed 12946886Rush 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.
- Background: PubMed 23649787Wells 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.
- Derived from this study: PubMed 35101100Hankerson 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olajide Williams, MD, MS study chair
Columbia University
Sidney Hankerson, MD, MBA principal investigator
Icahn School of Medicine at Mount Sinai
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SBIRT and Referral as Usual in people with Depression, run by Columbia University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment Engagement at 3-month Follow-up (time frame: Measured at 3-months post-screening). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04524767, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2026.