Depression Screening for Depression

No longer recruiting at 2 trial locations

Overseen By Sidney Hankerson, MD, MBA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Columbia University

Disqualifiers: Active suicidality, Homicidal ideation, Psychotic symptoms, Formal mental health treatment

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of Community Health Workers in screening for depression in Black churches. It compares two approaches: one group receives a detailed screening, a short counseling session, and a referral to specialized care if needed (SBIRT, which stands for Screening, Brief Intervention, and Referral to Treatment), while the other group receives educational materials and contact information for local treatment providers (Referral as Usual). Researchers aim to determine which method better engages people in treatment and improves their mental health quality of life. Fluent English-speaking adults who often feel depressed or anxious but are not currently receiving formal mental health care might be a good fit. As an unphased trial, this study offers a unique opportunity to contribute to understanding effective depression screening methods in community settings.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that these methods are safe for depression screening?

Research has shown that SBIRT (Screening, Brief Intervention, and Referral to Treatment) is a well-researched method. It effectively identifies and assists individuals with substance use and mental health issues. Studies have demonstrated that SBIRT can improve outcomes for those who use substances, and it is a proven method in many healthcare settings.

Although specific safety data for using SBIRT in depression screening might not be available, its widespread use in healthcare suggests it is generally well-tolerated. SBIRT includes a screening tool, a short counseling session, and a referral to treatment if needed. These steps are non-invasive and usually carry minimal risk. Overall, SBIRT is a trusted and safe method for various health conditions. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it compares two different approaches to depression screening and referral. The SBIRT method is unique because it integrates screening with the Patient Health Questionnaire-9 (PHQ-9), offers a brief intervention using Motivational Interviewing (MI), and provides referrals to specialized treatment if depressive symptoms persist. Unlike standard care, which often involves only distributing educational materials and contact information, SBIRT actively engages individuals in the screening process and may offer more personalized support. This approach could potentially lead to better identification and treatment of depression, making it a promising avenue for improving mental health care.

What evidence suggests that this trial's treatments could be effective for depression?

Research has shown that SBIRT (Screening, Brief Intervention, and Referral to Treatment), one of the treatment options in this trial, can help with depression. In past studies, teenagers who underwent SBIRT reduced substance use and depression more effectively and visited the emergency room less often over three years. SBIRT also increased the number of individuals who abstained from alcohol and illegal drugs. Additionally, SBIRT effectively identifies and addresses mental health issues, including depression. These findings suggest that SBIRT could be a promising way to improve mental health for people with depression. Participants in this trial may receive SBIRT or the alternative treatment option, Referral as Usual, which involves distributing depression educational materials and contact information for treatment providers. ^{1 6 7 8 9}

Who Is on the Research Team?

Olajide Williams, MD, MS

Principal Investigator

Columbia University

Are You a Good Fit for This Trial?

This trial is for English-speaking adults over 18 in Black church communities who may be experiencing depression, as indicated by specific questionnaire scores. It's not open to those already in formal mental health treatment or individuals with active suicidal thoughts, homicidal ideation, or psychotic symptoms.

Inclusion Criteria

Fluent in English

You have a score of 10 or higher on the Patient Health Questionnaire-9.

You have a high score (10 or more) on two questionnaires that measure symptoms of depression and anxiety.

Exclusion Criteria

I am currently in treatment for a mental health condition.

I have not had thoughts of harming myself or others, nor experienced severe mental health symptoms.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Intervention

Participants receive either SBIRT or Referral As Usual intervention

3-6 months

Multiple visits (in-person and virtual)

Follow-up

Participants are monitored for changes in mental health-related quality of life and depressive symptoms

6 months

2 visits (in-person or virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Referral as Usual
• SBIRT

Trial Overview

The study compares two approaches: usual referral methods versus a more involved process called SBIRT (Screening, Brief Intervention, and Referral to Treatment) conducted by Community Health Workers. The effectiveness on engaging patients with depression treatments will be measured.

How Is the Trial Designed?

Group I: SBIRT Experimental Treatment 1 Intervention

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.

Group II: Referral As Usual Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials

1,529

Recruited

2,832,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Published Research Related to This Trial

A quality improvement project at a multicultural health center successfully increased depression screening and follow-up rates from 9.1% to 71.4% through the implementation of structured interventions over 90 days.

Using standardized Patient Health Questionnaire (PHQ) tools in multiple languages significantly improved screening rates to 85.2%, leading to a positive incidence of depression in 45.5% of clients, highlighting the importance of culturally sensitive approaches in healthcare.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Not Missing the Opportunity: Improving Depression Screening and Follow-Up in a Multicultural Community. Schaeffer, AM., Jolles, D.[2020]

A survey of 890 middle and high school students showed that 74% found the SBIRT program useful in addressing substance use, indicating its potential effectiveness in school settings.

Students who reported substance use were less supportive of screening for substance use in schools, suggesting a need for tailored approaches to engage these students in SBIRT programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Student Experience of School Screening, Brief Intervention, and Referral to Treatment. Chadi, N., Levy, S., Wisk, LE., et al.[2021]

The Massachusetts consultation call line for pediatric primary care successfully facilitated 407 encounters with 108 unique families in one year, providing support for managing adolescent substance use disorders (SUD).

Most consultations (68%) led to recommendations for managing SUD in primary care, and medications for treatment were suggested in over half (54%) of the cases, indicating the program's effectiveness in integrating substance use management into pediatric care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Phone Consultation Call Line to Support SBIRT in Pediatric Primary Care. Levy, S., Fuller, A., Kelly, S., et al.[2022]

The implementation of a quality improvement process over 10 weeks led to a 23.82% reduction in referral barriers reported by nurses and a 21.12% increase in the perceived helpfulness of the SBIRT process.

The study demonstrated that systematic changes in workflow and communication significantly improved the integration of SBIRT in a Federally Qualified Health Center, resulting in more patients receiving this important mental health and substance abuse screening.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Workflow Improvement and the Use of PDSA Cycles: An Exploration Using Screening, Brief Intervention, and Referral to Treatment (SBIRT) Integration. Moser, T., Edwards, J., Pryor, F., et al.[2021]

Depression is a widespread issue in Australia, leading to significant disability, but current screening tools are nonspecific and cannot replace thorough clinical interviews for accurate diagnosis.

Screening tools alone have not been shown to improve outcomes for individuals with depression, and their arbitrary cut-off points may inflate prevalence rates without necessarily indicating a need for clinical intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The depression puzzle. Do the pieces fit? Holmwood, C., Jones, DS., Jackson-Bowers, E.[2006]

The study identified seven distinct SBIRT processes for substance use and five for tobacco use across 14 acute care facilities, highlighting variability in implementation despite a consistent overall function.

To effectively disseminate SBIRT in acute care settings, it is crucial to understand and tailor the implementation strategies to the specific local contexts and clinician involvement at each facility.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Variation in SBIRT delivery among acute care facilities. Keen, A., Thoele, K., Newhouse, R.[2020]

This study will test a nurse-led toolkit designed to enhance the implementation of Screening, Brief Intervention, and Referral to Treatment (SBIRT) in 14 acute care hospitals, aiming to improve the recognition and treatment of risky substance use among patients.

The effectiveness of the SBIRT toolkit will be evaluated by analyzing documentation of its delivery in electronic medical records over 12 months, with the goal of improving clinician engagement in addressing substance use issues and ultimately reducing substance use disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Study protocol testing toolkit versus usual care for implementation of screening, brief intervention, referral to treatment in hospitals: a phased cluster randomized approach. Newhouse, R., Janney, M., Gilbert, A., et al.[2020]

The SBIRT program was implemented in three Primary Care Medical Homes in North Texas to provide early intervention for individuals with Alcohol Use Disorder and Substance Use Disorders, aiming to support their stabilization and reintegration into the community.

Preliminary results indicate that the program successfully provided SBIRT services, with goals to reduce substance use and improve health outcomes measured at a 6-month follow-up, potentially decreasing emergency department visits and associated costs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Screening, brief intervention, and referral to treatment (SBIRT) implementation in urban underserved family medicine. Bednar, H., Bergs, K., Serdarevic, M.[2023]

A study involving 361 undergraduate student nurses showed that SBIRT training significantly increased their knowledge, confidence, and perceived competence in addressing substance use disorders, with 89% reporting improved skills.

The majority of students (93%) expressed intent to apply their SBIRT skills in future practice, highlighting the importance of integrating this training into nursing education to enhance substance use screening in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Student Nurse Screening, Brief Intervention and Referral to Treatment Training Program: Analysis 2016-2019. Zucker, DM., Rataj, S., Linowski, S., et al.[2023]

In a study of 306 adults in Ethiopia, the PHQ-9, SRQ-20, K6, and K10 screening questionnaires were found to be valid for detecting Major Depressive Disorder (MDD), with good performance indicated by area under the curve values between 0.83 and 0.85.

Despite their validity, the screening questionnaires do not yet have immediate applicability in routine clinical settings, highlighting the need for further research to integrate these tools effectively into health systems for better MDD detection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validity of brief screening questionnaires to detect depression in primary care in Ethiopia. Hanlon, C., Medhin, G., Selamu, M., et al.[2022]

The study analyzed prescreening outcomes from 14,447 patient visits in both inpatient and outpatient settings, finding that both the medical setting and the method of prescreening (self-administered vs interview) significantly influenced the results.

Among patients who prescreened positive for alcohol, the setting also affected their mean screening scores, indicating that the effectiveness of SBIRT may vary based on the context and method of administration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Assessment of SBIRT Prescreening and Screening Outcomes by Medical Setting and Administration Methodology. Agley, J., Crabb, DW., Harris, LE., et al.[2020]

Depression screening is not currently supported as a quality indicator due to limitations in technology that prevent accurate tracking of who should be screened and the effectiveness of the screening process itself.

While screening may increase the diagnosis of depression, it does not necessarily lead to improved patient outcomes, and there are more effective interventions available that should be prioritized for quality improvement efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Depression screening as a quality indicator. Luchins, DJ.[2021]

Depression affects over 300 million people worldwide and is the leading cause of disability, highlighting the urgent need for improved recognition and treatment.

Using a measurement-based care approach with validated screening tools can significantly enhance the recognition and diagnosis of depression, and routine screening is recommended by the US Preventive Services Task Force for adults and adolescents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Major Depressive Disorder in Primary Care: Strategies for Identification. Trivedi, MH.[2020]

The SBIRT program was implemented in ten primary care practices, screening nearly 50,000 patients for conditions like substance abuse and mental health issues, demonstrating its potential to identify at-risk individuals early.

Eight best practices for successful SBIRT implementation were identified, including having a practice champion and integrating SBIRT into electronic health records, which can enhance the effectiveness of primary care providers in addressing these health concerns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementing SBIRT (Screening, Brief Intervention and Referral to Treatment) in primary care: lessons learned from a multi-practice evaluation portfolio. Hargraves, D., White, C., Frederick, R., et al.[2022]

Citations

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The percentage of clients who reported they had not used alcohol or illegal drugs within the past 30 days increased by 128.8% between initial ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7786828/

Three-Year Outcomes After Brief Treatment of Substance ...

Adolescents with access to SBIRT had improved substance use and depression outcomes and fewer emergency department visits at 3 years.

3.

pubmed.ncbi.nlm.nih.gov

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Study protocol for comparing Screening, Brief Intervention ...

Secondary outcomes will be changes in Mental Health-Related Quality of Life and depressive symptoms at 3 and 6 months post-screening. Lastly, we ...

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annfammed.org

annfammed.org/content/annalsfm/13/3/261.full.pdf

SBIRT as a Vital Sign for Behavioral Health Identification, ...

5 The purpose of this study is to examine the effectiveness of the. Screening, Brief Intervention, and Referral to Treatment (SBIRT) program in a federally ...

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samhsa.gov

samhsa.gov/sites/default/files/sbirtwhitepaper_0.pdf

Evidence Supporting the Effectiveness of an SBIRT

This report discusses the evidence supporting the effectiveness of screening, brief intervention, and referral to treatment (SBIRT) as a ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5809898/

Implementing SBIRT (Screening, Brief Intervention and ...

SBIRT is an effective tool that can empower primary care providers to identify and treat patients with substance use and mental health problems ...

7.

sciencedirect.com

sciencedirect.com/science/article/pii/S1555415525001473

Assessing College Students' Mental Health and Substance ...

SBIRT = Screening, Brief Intervention, and Referral to Treatment. Of 606 students screened, 38.1% (n = 231) screened negative with a score of 0, while 61.9% (n ...

8.

oasas.ny.gov

oasas.ny.gov/sbirt

SBIRT: Screening, Brief Intervention & Referral to Treatment

SBIRT has been shown to be valid and reliable in identifying and improving outcomes for people who use substances.

9.

cms.gov

cms.gov/outreach-and-education/medicare-learning-network-mln/mlnproducts/downloads/sbirt_factsheet_icn904084.pdf

Screening, Brief Intervention & Referral to Treatment ( ...

We cover reasonable and necessary SBIRT services you provide to evaluate or treat patients with signs or symptoms of illness or injury, according to section ...