Skip to main content
OpenTrials
Completed

NCT Number: NCT03882411

An IT Approach to Implementing Depression Treatment in Cardiac Patients (iHeart DepCare)

The purpose of this study is to examine the effect of a brief electronic shared decision making (eSDM) intervention on depressive symptoms in coronary heart disease patients with elevated depressive symptoms.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Depressive Symptoms Behavior Behavioral Symptoms Cardiovascular Diseases Coronary Disease Coronary Heart Disease Depression Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Columbia University Irving Medical Center/New York Presbyterian Hospital

New York, 10032, United States

About this study

Depression is common in patients with coronary heart disease and associated with increased cardiac morbidity and mortality. Treating depressive symptoms appears to improve depressive symptoms and quality of life. Despite expert recommendations to screen and treat depressive symptoms fewer coronary heart disease patients engage in depression treatment than the general population, perhaps due to 1) sub-optimal provider awareness and referral rates and 2) low self-efficacy, stigma and misattribution of depressive symptoms among coronary heart disease patients. In addition, few real world theory-informed implementation trials exist for improving screening and treatment in outpatient settings.

The specific aim is to determine whether an electronic shared decision making (eSDM) and behavioral activation tool improves depressive symptoms and treatment initiation in coronary heart disease patients with elevated depressive symptoms. To accomplish these aims, a hybrid effectiveness-implementation trial will be conducted using a pre-post design across socioeconomically diverse cardiology and primary care clinics.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • History of coronary heart disease
  • English or Spanish Speaking
  • Elevated Depressive symptoms (PHQ9 ≥10)
  • Appointment at participating cardiology or primary care clinics

Exclusion criteria

  • Under the care of a psychiatrist [**On 6/22/2022, this exclusion criteria was removed for those clusters of clinics not already in the post-implementation period**]
  • Diagnosis/history of psychosis or schizophrenia
  • Diagnosis/history of bipolar disorder
  • Attempted suicide
  • Non-English or Spanish speaking
  • Dementia or severe cognitive impairment
  • Non-elevated depressive symptoms
  • Alcohol or substance abuse
  • Pregnancy

Treatment and study plan

Electronic shared decision making (eSDM) tool

Behavioral

The web application includes depression screening, behavioral activation, and a patient preference driven treatment selection decision aid. Treatment options will include medications, cardiac rehab/exercise program, and therapy. In addition to education, providers will receive a patient preference report in real time with options for coordination of care

Other names: eSDM intervention

Primary outcomes

  1. Beck Depression Index (BDI-II)

    Time frame: Baseline, Follow-up visit (approximately 6 months)

    Change in total BDI (21-item measure of depressive symptoms [0-63]; higher score constitutes worse burden of symptoms) from baseline to follow visit during the pre-intervention period compared to post-intervention period

Secondary outcomes

  1. Proportion of patients who initiate treatment

    Time frame: Baseline, Follow-up visit (approximately 6 months)

    Proportion of enrolled patients who initiate any depression treatment (medications, cardiac rehab/exercise program, therapy) from baseline to follow up visit in the pre-intervention compared to post-intervention period

  2. Mean Patient Activation

    Time frame: Baseline

    Mean baseline patient activation measure [PAM] (13-items, range 0-100, higher score indicates greater activation] in the pre-intervention compared to post-intervention period

  3. Mean Decisional Conflict Scale

    Time frame: Baseline

    Mean decisional conflict (measures personal perceptions of uncertainty around choosing among treatment option, 10 items, range 0-100, higher score indicates greater conflict) of patients.

  4. Mean change in quality of life (QoL)

    Time frame: Baseline, Follow-up visit (approximately 6 months)

    Change in QoL from from baseline to follow up visit in the pre-intervention compared to post-intervention period

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

An Information tecHnology Approach to implEmenting Depression treAtment in caRdiac patienTs: [iHeartDepCare Trial]

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
Mar 20, 2019
Registry last updated
Jun 13, 2025

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.