Engagement Navigator Service for Depression

Overseen By Melanie Bennett

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Maryland, Baltimore

Disqualifiers: Not in age range, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new service called the Engagement Navigator Service (ENS) to help people maintain their mental health care connections. It supports those at risk of losing contact with their Coordinated Specialty Care (CSC) programs, which assist with early episode psychosis. The trial will determine if this service facilitates patient and family involvement in treatment. Suitable participants include those currently receiving CSC program services for early episode psychosis. As an unphased trial, this study provides a unique opportunity to contribute to innovative mental health care solutions.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Engagement Navigator Service is safe for participants and families?

Research has shown that the Engagement Navigator Service (ENS) leads to positive results in mental health care. Studies have found that programs like ENS improve the use of mental health services and increase the likelihood of continued treatment. Participants often report feeling less depressed and anxious, along with an improved quality of life.

Importantly, these services are generally easy to manage. Similar programs have reported no major negative effects, suggesting that ENS is a safe choice for those considering joining the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Engagement Navigator Service (ENS) for depression because it offers a unique approach to patient support and engagement, unlike traditional medication or therapy options. ENS is a centralized service with professionals who specialize in engagement science, providing personalized support to patients struggling with depression, especially when their relationships with treatment programs are poor. This service is designed to re-engage patients with care or connect them with preferred services and maintain contact even with those who initially refuse treatment, offering a continuous support system that current options may lack.

What evidence suggests that the Engagement Navigator Service is effective for improving disengagement outcomes in depression?

Research has shown that services like the Engagement Navigator Service (ENS), available to participants in this trial, can increase patient satisfaction and involvement in their care. Studies have found that these services help individuals adhere to their treatment plans more effectively, leading to improved mental health. Specifically, care navigation has been linked to positive mental health outcomes, particularly in severe cases. This suggests that the ENS might help reduce depression by maintaining patient connection to their care. Overall, evidence supports that these services can effectively enhance engagement and mental health outcomes. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for individuals aged 13-35 who are currently receiving treatment at early episode psychosis programs and are at high risk of disengaging from their care. It aims to help participants and families stay connected with treatment services.

Inclusion Criteria

I am currently getting help from an early psychosis treatment program.

I am between 13 and 35 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Development and Implementation

Development of the Engagement Navigator Service (ENS) using participatory research methods and implementation in three CSC programs

6 months

Feasibility and Acceptability Testing

Conduct mixed methods feasibility and acceptability testing of ENS in three CSC programs

6 months

Evaluation

Conduct a mixed methods evaluation of ENS offered hub wide using a hybrid type I, stepped wedge cluster randomized controlled trial

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Engagement Navigator Service

Trial Overview The trial is testing a new service called the Engagement Navigator Service (ENS), designed to prevent patients in mental health care from dropping out. The effectiveness, feasibility, and acceptability of ENS will be evaluated across several care programs using research methods that involve staff, patients, and families.

How Is the Trial Designed?

Group I: Engagement Navigator Service (ENS) Experimental Treatment 1 Intervention

ENS will be a centralized service, staffed by dedicated professional to (1) receive and organize referrals, (2) complete ongoing specialized training in engagement science and evidence-based strategies, (3) provide unbiased support when participants' and/or families' relationships with a CSC program are poor, (4) re-engage participants in CSC or actively connect them with other services if preferred, and (5) continue contact with those who refuse treatment in case they reconsider.

Group II: No ENS Active Control 1 Intervention

Those who do not participate in ENS will comprise the no intervention arm.

Who Is Running the Clinical Trial?

University of Maryland, Baltimore

Lead Sponsor

Trials

729

Recruited

540,000+

Published Research Related to This Trial

The TeleCoach intervention significantly improved adherence to the web-based moodManager program, leading to more frequent logins and greater engagement with the content compared to self-directed use.

While TeleCoach+moodManager showed lower depressive symptoms compared to a waitlist control at week 6, there were no significant differences in symptom reduction when compared to self-directed moodManager, highlighting ongoing challenges with adherence in web-based depression treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled trial evaluating a manualized TeleCoaching protocol for improving adherence to a web-based intervention for the treatment of depression. Mohr, DC., Duffecy, J., Ho, J., et al.[2022]

This study aims to assess the relative and absolute risks of adverse events associated with different classes of antidepressants in adults under 65 diagnosed with depression, using a large primary care database (QResearch) and following patients from 2000 to 2012.

By analyzing various adverse outcomes such as mortality, suicide, and cardiovascular events, the study will provide important insights into the long-term safety of antidepressants, helping to inform prescribing practices in primary care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of antidepressants in adults aged under 65: protocol for a cohort study using a large primary care database. Coupland, C., Morriss, R., Arthur, A., et al.[2021]

Enhanced evidence-based care (EEC) models, including Collaborative Care and Algorithm-guided Treatment, significantly improve treatment outcomes for depression compared to usual care, with a response rate increase of 30% and remission rate increase of 35% based on a meta-analysis of 29 studies involving 15,255 participants.

Despite the improved effectiveness of EEC, the rate of discontinuation from treatment was similar to that of usual care, indicating that EEC is a safe option for managing depression without increasing dropout rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of enhanced evidence-based care for depressive disorders: a meta-analysis of randomized controlled trials. Xiao, L., Qi, H., Zheng, W., et al.[2021]

A patient navigation system was successfully implemented in a Head Start preschool setting, with 47 low-income mothers participating and no refusals, indicating high acceptability of the program.

The navigators maintained excellent fidelity to the model, and importantly, there were no adverse events reported, suggesting the intervention is safe for participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Harnessing the Capacity of Head Start to Engage Mothers with Depression in Treatment. Silverstein, M., Diaz-Linhart, Y., Grote, N., et al.[2022]

Postmarketing safety evaluations of antidepressant drugs can benefit from data collected through systems like the FDA Adverse Event Reporting System and electronic medical records, which provide more extensive information than premarketing trials.

The study assesses the strengths and limitations of these data sources for pharmacovigilance, highlighting the need for consistent results and integration of evidence to improve drug safety monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

On the evidence consistency of pharmacovigilance outcomes between Food and Drug Administration Adverse Event Reporting System and electronic medical record data for acute mania patients. Duan, R., Zhang, X., Du, J., et al.[2021]

A review of 10 clinical trials on esketamine for resistant depression found that 90% of the trials had low-quality reporting of adverse events (AEs), indicating significant gaps in safety data.

The study revealed that 41.5% of serious AEs and 39% of non-serious AEs were not reported in published articles, particularly psychiatric and cardiovascular events, suggesting that the assessment of esketamine's risk-benefit balance may be inaccurate due to incomplete harm reporting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reporting of harms in clinical trials of esketamine in depression: a systematic review. Taillefer de Laportalière, T., Jullien, A., Yrondi, A., et al.[2023]

Citations

1. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK599335/

Is a Patient Navigation Program More Helpful than a Referral ... Studies demonstrate that patient navigation can result in improved patient satisfaction, engagement, and outcomes. ... The PHQ-9 is a screen for major depressive ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8479400/

Engagement with mobile health interventions for depression The aim of this systematic review is to examine assessment and reporting of engagement in clinical trials of mHealth interventions for depression.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0165032725002575

Evaluating clinical outcomes for anxiety and depression We aim to evaluate the effectiveness of a blended hybrid care model, the Digital Clinic, in reducing anxiety and depression, compared to a large primary care ...

4. jmir.org jmir.org/2025/1/e67597

Understanding Engagement With Digital Mental Health ... While MBC has demonstrated positive outcomes in mental health treatment, its effectiveness is constrained by the extent to which both ...

5. journals.plos.org journals.plos.org/plosone/article/file?type=printable&id=10.1371/journal.pone.0331454

A remote care navigation solution associated with improved ... Care navigation has shown promising results in several mental health contexts. In severe cases of mental illness, peer and community-based care ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12445557/

A nationwide cohort study in the USA - PMC Participants using care navigation had improved mental healthcare utilization, retention, and reduced depression and anxiety, which was ...

7. nature.com nature.com/articles/s41746-025-01511-7

Randomized controlled study of a digital data driven ... Specifically, we observed significant reductions in both depression and anxiety symptoms, accompanied by an improvement in quality of life.

8. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2819255

Digital Engagement Strategy and Health Care Worker ... Secondary outcomes include 9-month change in PHQ-9 and GAD-7 and 6- and 9-month changes in well-being (WBI and WHO-5), and productivity (LEAPS) ...

9. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/imhj.22075

Patient navigation models for mental health of parents ... Patient navigation (PN) aims to improve timely access to healthcare by helping patients to “navigate” complex service provision landscapes.