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Behavioral Intervention

eSDM Tool for Depression in Heart Disease

N/A

Recruiting

Led By Nathalie Moise, MD, MS

Research Sponsored by Columbia University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

History of coronary heart disease

Be older than 18 years old

Must not have

Dementia or severe cognitive impairment

Non-English or Spanish speaking

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, follow-up visit (approximately 6 months)

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a digital tool that helps heart disease patients with depression work with their doctors to choose the best treatment. The tool also encourages patients to engage in activities that can improve their mood. The goal is to see if this approach reduces depressive symptoms and helps more patients start treatment.

Who is the study for?

This trial is for heart disease patients who also have significant depression symptoms (PHQ9 score ≥10) and speak English or Spanish. It's not for those with psychosis, schizophrenia, bipolar disorder, recent suicide attempts, severe cognitive issues, non-elevated depression symptoms, current pregnancy, or substance abuse problems.

What is being tested?

The study is testing an electronic shared decision making tool (eSDM) designed to help coronary heart disease patients manage elevated depressive symptoms more effectively through technology-assisted care.

What are the potential side effects?

Since this intervention involves a decision-making support tool rather than medication or invasive therapy, traditional physical side effects are not expected. However, emotional distress due to discussing sensitive health information may occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have a history of heart disease.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have dementia or severe problems with my memory and thinking.

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I do not speak English or Spanish.

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I have been diagnosed with or have a history of psychosis or schizophrenia.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, follow-up visit (approximately 6 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, follow-up visit (approximately 6 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, follow-up visit (approximately 6 months) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Beck Depression Index (BDI-II)

Secondary study objectives

Mean Decisional Conflict Scale

Mean Patient Activation

Mean change in quality of life (QoL)

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Electronic shared decision making (eSDM) ToolExperimental Treatment1 Intervention

In the pre-intervention period, patients in clinic clusters will receive usual care. When a clinic cluster's randomly allotted intervention period arrives, coronary heart disease patients in that given clinic cluster will complete a web application, which delivers screening, behavioral activation and shared decision making (eSDM), and providers will receive education and a patient preference report generated from the application. During both the pre and post intervention periods, patients will be assessed at baseline and 6 month follow up.

0 / 4Eligibility criteria met