200 Participants Needed

iHeart DepCare Tool for Depression

(iHeart_2 Trial)

NM
Overseen ByNathalie Moise, MD, MS, FAHA
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Columbia University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new tool called iHeart DepCare to help treat depression in people with coronary heart disease (CHD). The study aims to determine if this tool, combined with additional support, can improve depression care compared to the usual treatment approach. Participants will be randomly assigned to either receive only depression screening or use the iHeart DepCare tool with motivational support. Potential participants include CHD patients who have experienced depression symptoms and are seeing a primary care doctor or cardiologist at Columbia. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance depression care for CHD patients.

What prior data suggests that the iHeart DepCare tool is safe for use in depression treatment among CHD patients?

Research has shown that the iHeart DepCare tool has been used in various studies to help manage depression, particularly for heart disease patients. This tool includes a questionnaire and uses easy-to-understand visuals to facilitate decision-making between patients and doctors. In past studies, patients used it without encountering major safety issues.

The tool aims to improve treatment for people with depression and presents no known risks. In the studies conducted, both patients and healthcare providers found it helpful. There have been no significant reports of harmful effects from using the iHeart DepCare tool.

Overall, current research considers the tool safe. It focuses on enhancing patient involvement and treatment for depression, with no serious side effects reported in the studies reviewed so far.12345

Why are researchers excited about this trial?

Researchers are excited about the iHeart DepCare tool because it integrates motivational interviewing and personalized support into depression management for patients with heart conditions. Unlike traditional treatments that often involve medication or therapy alone, this tool provides a holistic approach by incorporating patient preferences and ongoing support from healthcare providers. This personalized method could lead to better engagement and outcomes for patients, making it a promising addition to depression care in a cardiology setting.

What evidence suggests that the iHeart DepCare tool is effective for depression in CHD patients?

Research has shown that the iHeart DepCare tool, available to participants in this trial, may help reduce depression symptoms in people with coronary heart disease (CHD). This tool includes a simple questionnaire to check for depression and a plan to manage it. Studies have found that using iHeart DepCare helps patients better understand and engage with their treatment options. Over time, patients who used the tool reported feeling less depressed. It also aids healthcare providers in referring patients for additional treatment when needed. Early results suggest that iHeart DepCare improves depression care for both patients and healthcare providers in everyday settings.12678

Who Is on the Research Team?

NM

Nathalie Moise, MD, MS, FAHA

Principal Investigator

Columbia University

Are You a Good Fit for This Trial?

This trial is for coronary heart disease patients at Columbia University Irving Medical Center who show signs of depression. They must be due for primary care or cardiology appointments and willing to use the iHeart DepCare tool if randomized to do so.

Inclusion Criteria

I am over 18 years old.
Has a PCP at NYP/Columbia active on the NYP/Columbia EHR
I have a history of heart disease.
See 2 more

Exclusion Criteria

History of severe mental illness (bipolar disorder, schizophrenia, chronic/recurrent depression, history of suicide attempt or self-inflicted injuries)
I do not speak English or Spanish.
Dementia
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks
1 visit (virtual)

Treatment

Participants receive the iHeart DepCare tool and motivational interviewing support

6 months
Ongoing support as needed

Follow-up

Participants are monitored for safety and effectiveness after treatment

3-9 months
Regular follow-up visits

What Are the Treatments Tested in This Trial?

Interventions

  • iHeart DepCare tool

Trial Overview

The study tests if the iHeart DepCare tool, along with support from Clinic Navigators, improves adoption of depression treatment in cardiac patients. It compares usual care against using this tool, focusing on how well it helps manage depression.

How Is the Trial Designed?

2

Treatment groups

Active Control

Group I: Screening aloneActive Control1 Intervention
Group II: Screening plus iHeart DepCare tool and Motivational InterviewingActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials
1,529
Recruited
2,832,000+

National Institute on Aging (NIA)

Collaborator

Trials
1,841
Recruited
28,150,000+

Citations

A Patient Activation Approach to Implementing Depression ...

The research now expands to test the real-world effectiveness of the iHeart DepCare tool in cardiology and primary care settings. Official ...

Implementing depression treatment for cardiac populations ...

The primary effectiveness outcome is change in depressive symptoms from baseline to follow-up during the post-implementation period compared to pre- ...

3.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39978664

Implementing depression treatment for cardiac populations in ...

The IHEART DEPCARE Trial is the first hybrid type II effectiveness-implementation trial to examine the effect of a brief, theory-informed eSDM and patient ...

Behavioral RCTs | Division of Cardiology

Here, we will refine and evaluate a multi-component iHeart DepCare intervention in real world settings by conducting a provider-level cluster randomized control ...

Increasing Uptake of Depression Screening and Treatment ...

The multilingual patient activation/persuasion eSDM tool (iHeart DepCare) includes a screening questionnaire and depression profile ...

Increasing Uptake of Depression Screening and Treatment ...

The final multicomponent strategy (iHeart DepCare) for promoting depression screening/treatment included problem-solving meetings with clinic staff (system); ...

Increasing uptake of depression screening and treatment ...

The multilingual patient activation/persuasion eSDM tool (iHeart DepCare) includes a screening questionnaire and depression profile, infographics and a script ...

An IT Approach to Implementing Depression Treatment in ...

The specific aim is to determine whether an electronic shared decision making (eSDM) and behavioral activation tool improves depressive symptoms and treatment ...