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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
English or Spanish Speaking
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, follow-up visit (approximately 6 months)
Awards & highlights
Study Summary
This trial will test whether a brief electronic intervention can help reduce depressive symptoms in coronary heart disease patients.
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.Check my eligibility
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.See study design
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 belowSelect...
I have a history of heart disease.
Select...
I speak English or Spanish.
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)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Beck Depression Index (BDI-II)
Secondary outcome measures
Mean Decisional Conflict Scale
Mean Patient Activation
Mean change in quality of life years (QALYs)
+1 moreTrial 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.
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Who is running the clinical trial?
Columbia UniversityLead Sponsor
1,426 Previous Clinical Trials
2,473,440 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,820 Previous Clinical Trials
47,299,069 Total Patients Enrolled
Nathalie Moise, MD, MSPrincipal Investigator - Columbia University
New York Presbyterian Hospital-Columbia Presbyterian Center, Trustees of Columbia University in the City of New York
1 Previous Clinical Trials
266 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have dementia or severe problems with my memory and thinking.I do not have severe depression.I do not speak English or Spanish.You have high levels of depressive symptoms, as indicated by a score of 10 or more on the PHQ9 questionnaire.I have a history of heart disease.You have a history of alcohol or drug abuse.I speak English or Spanish.I have been diagnosed with or have a history of psychosis or schizophrenia.You have been diagnosed with or have a history of bipolar disorder.You have tried to harm yourself on purpose.
Research Study Groups:
This trial has the following groups:- Group 1: Electronic shared decision making (eSDM) Tool
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are researchers currently accepting participants for this research project?
"As evidenced on clinicaltrials.gov, this medical research is presently recruiting participants. This trial was initially uploaded to the website back in April 2019 and underwent its last edit October 2022."
Answered by AI
How many research participants are engaged in this clinical trial?
"Indeed, clinicaltrials.gov indicates that this trial is actively enrolling participants. It was initiated on April 23rd 2019 and the latest updates were made on October 28th 2022. The study requires 368 patients from one single medical centre to participate in it."
Answered by AI
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