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NCT Number: NCT07390331

A Patient Activation Approach to Implementing Depression Treatment in Cardiac Patients

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.

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Key information

Conditions

Depression and CVD Behavior Behavioral Symptoms Cardiovascular Diseases Depression Health Behavior Patient Acceptance of Health Care Patient Participation Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Columbia University Irving Medical Center

New York, 10032, United States

Location status: Recruiting

Location contact

Nathalie Moise, MD, MS, FAHA

CONTACT

212-342-2889

Nathalie Moise, MD, MS, FAHA

PRINCIPAL_INVESTIGATOR

About this study

Depression is common in patients with coronary heart disease (CHD) and associated with increased cardiac morbidity and mortality. Evidence-based mental health treatment improves depressive symptoms and quality of life, yet few CHD patients engage in treatment. The investigator previously tested the efficacy of an implementation strategy centered around a patient activation and psychoeducation tool (iHeart DepCare) for improving depressive symptoms and uptake of depression treatment in CHD patients. The research now expands to test the real-world effectiveness of the iHeart DepCare tool in cardiology and primary care settings.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

iHeart Depcare tool

Behavioral

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 outcomes

  1. Percentage of eligible patients who initiate or intensify depression treatment

    Time frame: Up to 6 months

    This is designed to measure depression treatment reach, which is defined as the percentage of eligible patients who initiate or intensify depression treatment within 6 months of the index visit, as indicated by ≥1 pharmacy fill data of a new or changed antidepressant and/or a new visit with a mental health provider (e.g., psychologist, psychiatrist, behavioral health provider like social workers) and/or primary care provider with a visit diagnosis of depression and/or an exercise program (e.g., cardiac rehabilitation), which will be assessed through chart extraction and tallied.

Secondary outcomes

  1. Percentage of patients in whom their clinician referred to mental health treatment

    Time frame: Baseline

    This is designed to measure treatment adoption, which is defined as the percentage of patients in whom their clinician referred to mental health treatment (e.g., collaborative care, psychotherapy, psychiatry, cardiac rehab) and/or prescribed/changed antidepressants and/or psychological/supportive counseling at the index visit, which will be assessed through chart extraction and tallied.

  2. Mean adherence to cardiac medications

    Time frame: Approximately between 3 to 9 months from baseline

    Mean adherence will be assessed as the mean proportion of days covered (PDC) for key cardiovascular disease medications (i.e., statin, antihypertensives) based on fill dates in the 3-9 months after the index visit.

Study contacts

Contact information is provided by the study sponsor or research team.

Nathalie Moise, MD, MS, FAHA

CONTACT

[email protected]

212-342-2889

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

A Theory-Informed, Brief Patient Activation and Motivational Interviewing Approach to Implementing Depression Treatment in Cardiac Patients: A Quality Improvement Initiative

Acronym: iHeart_2

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Feb 5, 2026
Registry last updated
Mar 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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