NCT07390331 A Patient Activation Approach to Implementing Depression Treatment in Cardiac Patients
| NCT ID | NCT07390331 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Columbia University |
| Condition | Depression and CVD |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2026-03-03 |
| Primary Completion | 2028-05-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 200 participants in total. It began in 2026-03-03 with a primary completion date of 2028-05-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study, which is being conducted as part of a Quality Improvement (QI) Initiative at Columbia University Irving Medical Center, will test whether delivering the iHeart DepCare tool increases real world reach and adoption of depression treatment among CHD patients. As part of the QI Initiative, Clinic Navigators will administer and record (in EPIC) depression screening in advance of primary care and cardiology appointments. Eligible patients with elevated depressive symptoms will be randomized to receive usual care vs. the iHeart DepCare tool in conjunction with brief motivational, technical and navigation support per patient preference. Aim 1: To test the effect of iHeart DepCare on depression treatment optimization (primary outcome) among coronary heart disease patients with elevated depressive symptoms. Aim 2: To explore the effect of iHeart DepCare on implementation outcomes, including provider referrals, among coronary heart disease patients with elevated depressive symptoms.
Eligibility Criteria
Inclusion Criteria: * Over 18 years of age * PHQ9 or PHQ8 score \>=8 * History of coronary heart disease per EHR search for ICD-9 codes of 410-414 and ICD-10 codes: I20, I21, I22, I23, I24, I25. * Appointment with a primary care provider (PCP) or cardiologist in an integrated care setting in NYP/Columbia (e.g., does not include procedure or lab-only visits) * Has a PCP at NYP/Columbia active on the NYP/Columbia EHR Exclusion Criteria: * Not English or Spanish speaking * History of severe mental illness (bipolar disorder, schizophrenia, chronic/recurrent depression, history of suicide attempt or self-inflicted injuries) * Dementia * Had an integrated mental health visit in the last 3 months as indicated in the EHR * Enrollment in the post-implementation period of IRB# AAAR9175
Contact & Investigator
Nathalie Moise, MD, MS, FAHA
PRINCIPAL INVESTIGATOR
Columbia University
Frequently Asked Questions
Who can join the NCT07390331 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Depression and CVD. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07390331 currently recruiting?
Yes, NCT07390331 is actively recruiting participants. Contact the research team at nm2562@cumc.columbia.edu for enrollment information.
Where is the NCT07390331 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT07390331 clinical trial?
NCT07390331 is sponsored by Columbia University. The principal investigator is Nathalie Moise, MD, MS, FAHA at Columbia University. The trial plans to enroll 200 participants.
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