Recruiting

iHeart DepCare

Sponsor:

Columbia University

Code:

NCT07390331

Conditions

Depression and CVD

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

iHeart Depcare tool

Study Details

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.

Conditions

Depression and CVD

Study ID

NCT07390331

Start date

Mar 3, 2026

Status verified date

Mar, 2026

Completion date

Jan 31, 2029

Anticipated

Primary completion date

May 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

no intervention: Screening alone

As part of a Quality Improvement Initiative, navigators and clinical staff call patients to screen patients for depression using the Patient Health Questionnaire (PHQ)-2 followed by the PHQ-9 in advance of scheduled office visits with cardiologists or primary care clinicians and enter results into Epic for providers to view during their visits and refer and manage depression at their discretion. Patients will receive the clinic's mental health informational resource.

active comparator: Screening plus iHeart DepCare tool and Motivational Interviewing

As part of a Quality Improvement Initiative, navigators and clinical staff call patients to screen patients for depression using the Patient Health Questionnaire (PHQ)-2 followed by the PHQ-9 in advance of scheduled office visits with cardiologists or primary care clinicians and enter results into Epic for providers to view during their visits and refer and manage depression at their discretion.

Eligible patients who screen positive for depression (PHQ-9 ≥8) are administered the Heart DepCare tool along with motivational, technical and navigational support per patient preference. Clinical and mental health providers are sent the patient's treatment preferences via EPIC.

Interventions

iHeart Depcare tool

The iHeart DepCare tool is an electronic patient activation and psychoeducation tool (available in English and Spanish) designed to bridge depression screening with treatment. The tool includes: 1) a description of depressive symptoms; 2) a checklist of behavioral risk factors; 3) an animation of a CVD patient going through the process of symptom recognition, help seeking, and treatment completion following a CVD event; 4) psychoeducation videos; 5) depression treatment selection support (adapted to include behavioral risk factor preferences); and 6) additional cardiac resources the patient can reference. Patients may receive brief motivational interviewing as well as technical/navigational support per patient preference to reinforce learning. Patient treatment preferences are sent via EPIC to the mental health and treating providers.

Primary outcome measure

  • Percentage of eligible patients who initiate or intensify depression treatment [ Time Frame: Up to 6 months ]

Central Contacts and Locations

Central contacts

Nathalie Moise, MD, MS, FAHA

212-342-2889nm2562@cumc.columbia.edu

Locations

Columbia University Irving Medical Center

Recruiting

New York, New York, United States, 10032

Contacts

Nathalie Moise, MD, MS, FAHA

212-342-2889

Principal Investigator:

Nathalie Moise, MD, MS, FAHA

More Information

Sponsor

Columbia University

Last update posted

Mar 6, 2026

Last verified

Mar, 2026

Keywords

  • patient activation
  • depression treatment uptake
  • depression treatment optimization

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Columbia University on 2026-03-06.