Patient activation to improve depression care for people with coronary heart disease
Official title: A Theory-Informed, Brief Patient Activation and Motivational Interviewing Approach to Implementing Depression Treatment in Cardiac Patients: A Quality Improvement Initiative
Run by Columbia University · NCT07390331 · Data updated 2026-11-12
This project will test if the iHeart DepCare tool helps people with coronary heart disease and elevated depressive symptoms start and optimize depression treatment.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | Columbia University Academic / other |
| Locations | 1 site (New York, New York) |
| Status | Recruiting |
| Started | March 3, 2026 |
| Main results expected | May 30, 2028 |
| Study ends | January 31, 2029 |
| Registry record updated | March 6, 2026 |
| Trial ID | NCT07390331 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (18+) with a history of coronary heart disease, a PHQ-8/9 score ≥8, and a scheduled primary care or cardiology appointment within the NYP/Columbia integrated system who speak English or Spanish and have an active NYP/Columbia PCP are ideal candidates.
✕Probably not a fit
Patients with severe mental illness (e.g., bipolar disorder, schizophrenia, chronic/recurrent depression, history of suicide attempt), dementia, non-English/Spanish speakers, those who recently had an integrated mental health visit, or those not receiving care at NYP/Columbia are unlikely to benefit from this intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
As part of a quality-improvement initiative at Columbia, clinic navigators will screen patients for depression in the electronic health record before primary care or cardiology visits. Eligible adults with CHD and a PHQ-8/9 score of 8 or higher will be randomized to usual care or to receive the iHeart DepCare patient-activation tool plus brief motivational, technical, and navigation support as desired. The primary outcome is depression treatment optimization, and secondary analyses will examine implementation outcomes such as provider referrals and treatment uptake. The trial tests real-world effectiveness of a previously piloted patient-activation and psychoeducation approach in integrated care settings.
Why it matters
Potential benefit: If successful, more heart disease patients with depression could start and stay in evidence-based depression treatment, improving symptoms and quality of life.
How similar studies have gone: Prior efficacy work by the investigators using the iHeart DepCare activation and psychoeducation approach showed promising improvements in treatment uptake and depressive symptoms, but real-world effectiveness in routine care is still being tested.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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Columbia University Irving Medical Center
New York, New York, United States Recruiting
Study contacts
- Principal investigator: Nathalie Moise, MD, MS, FAHA — Columbia University
- Study coordinator: Nathalie Moise, MD, MS, FAHA
- Email: nm2562@cumc.columbia.edu
- Phone: 212-342-2889
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.