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

555 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This project will develop a hub-based engagement navigator service for participants and families at high risk for disengagement. The investigators will use robust Participatory Research methods to ensure integration of Coordinated Specialty Care (CSC) program staff, participants, and family members in developing all aspects of and materials for the service, conduct feasibility/acceptability testing in three CSC programs, and use this information to guide refinements. This will be followed by a mixed methods hub wide evaluation using a hybrid type I open cohort stepped wedge design to examine feasibility, acceptability, and effectiveness to improve disengagement outcomes and address target mechanisms.

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.

Is the Engagement Navigator Service safe for humans?

In a study involving 47 mothers with depression using the Engagement Navigator Service, there were no adverse events reported, suggesting it is generally safe for humans. ^{1 2 3 4 5}

How is the Engagement Navigator Service treatment for depression different from other treatments?

The Engagement Navigator Service for depression is unique because it focuses on enhancing patient engagement with treatment, which is often a challenge in depression care. It likely incorporates elements such as facilitator contact, discussion boards, and virtual badges to improve adherence, similar to other interventions that have shown success in increasing engagement and improving outcomes. ^{6 7 8 9 10}

What data supports the effectiveness of the Engagement Navigator Service treatment for depression?

Research shows that enhanced patient-provider engagement and evidence-based care models, like those used in the Engagement Navigator Service, can improve outcomes for depression. These approaches, which include measurement-based care and case management, have been shown to be more effective than usual care in reducing symptoms and increasing remission rates. ^{11 12 13 14 15}

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

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]

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]

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]

Citations

1. Canada pubmed.ncbi.nlm.nih.gov

Mobile App to Enhance Patient Activation and Patient-Provider Communication in Major Depressive Disorder Management: Collaborative, Randomized Controlled Pilot Study. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

The effectiveness of enhanced evidence-based care for depressive disorders: a meta-analysis of randomized controlled trials. [2021]

3. England pubmed.ncbi.nlm.nih.gov

How Effective Is Algorithm-Guided Treatment for Depressed Inpatients? Results from the Randomized Controlled Multicenter German Algorithm Project 3 Trial. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Improving depression care: barriers, solutions, and research needs. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Effectiveness of case management-based aftercare coordination by phone for patients with depressive and anxiety disorders: study protocol for a randomized controlled trial. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Harnessing the Capacity of Head Start to Engage Mothers with Depression in Treatment. [2022]

7. England 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. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Adverse event methods were heterogeneous and insufficiently reported in randomized trials on persistent depressive disorder. [2018]

9. England pubmed.ncbi.nlm.nih.gov

Reporting of harms in clinical trials of esketamine in depression: a systematic review. [2023]

10. England pubmed.ncbi.nlm.nih.gov

Safety of antidepressants in adults aged under 65: protocol for a cohort study using a large primary care database. [2021]

11. Canada pubmed.ncbi.nlm.nih.gov

Facilitator Contact, Discussion Boards, and Virtual Badges as Adherence Enhancements to a Web-Based, Self-guided, Positive Psychological Intervention for Depression: Randomized Controlled Trial. [2022]

12. United States 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. [2022]

13. United States pubmed.ncbi.nlm.nih.gov

Using moderator-based algorithms and electronic medical records to achieve optimal outcomes in depression. [2011]

14. United States pubmed.ncbi.nlm.nih.gov

Tech Connect: An Intervention to Promote Treatment Engagement for Adolescents with Depression. [2021]

15. Netherlands pubmed.ncbi.nlm.nih.gov

Targeting subjective engagement in experimental therapeutics for digital mental health interventions. [2023]