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Collaborative Care for Heart Conditions with Depression or Anxiety

N/A

Recruiting

Led By Jeff C Huffman, MD

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Admission for acute coronary syndrome (myocardial infarction or unstable angina) or acute heart failure.

Admission for acute coronary syndrome (myocardial infarction or unstable angina) or acute heart failure

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 26 weeks, 52 weeks

Awards & highlights

Study Summary

This trial will compare the effect of a 26-week blended collaborative care intervention to enhanced usual care in patients admitted for acute coronary syndrome or heart failure. The primary outcome is physical function at 26 weeks, as measured by the Duke Activity Status Index.

Who is the study for?

This trial is for adults with depression, generalized anxiety disorder, or panic disorder who are admitted to Massachusetts General Hospital or Brigham and Women's Hospital for acute coronary syndrome or heart failure. They must be fluent in English without cognitive deficits, have no complex psychiatric conditions like bipolar disorder or psychosis, and not be at immediate risk of death.Check my eligibility

What is being tested?

The study compares a 26-week collaborative care approach focusing on mental health, cardiac behaviors, and illness management against enhanced usual care in cardiac patients with certain mental health disorders. The main goal is to see if this care improves physical function and other patient-centered outcomes.See study design

What are the potential side effects?

Since the intervention involves non-pharmaceutical care coordination and behavioral support rather than medication, typical drug side effects are not expected. However, participants may experience varying levels of stress or emotional discomfort during psychological treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I was admitted for a heart attack or severe chest pain.

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I was admitted for a heart attack or severe chest pain.

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I have been diagnosed with depression, GAD, or PD based on specific questionnaires.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 26 weeks, 52 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 26 weeks, 52 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 26 weeks, 52 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in physical function

Secondary outcome measures

Change in cardiac medication adherence

Change in dietary adherence (saturated fat)

Change in dietary adherence (sodium intake)

+11 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Collaborative CareExperimental Treatment1 Intervention

Participants randomized to collaborative care (CC) will receive a 26-week, telephone based CC intervention. Care managers will monitor participants' psychiatric symptoms, review current treatments for their psychiatric and cardiac illnesses, deliver psychotherapeutic interventions, provide education about self-monitoring for cardiac symptoms, perform motivational interviewing to encourage health behavior adherence, and coordinate care between psychiatric/cardiac specialists and participants' primary care physicians. CC will utilize a treat-to-target approach, with a goal of remission of psychiatric and cardiac symptoms.

Group II: Enhanced Usual CareActive Control1 Intervention

Participants in the enhanced usual care (eUC) arm will not receive any specific intervention, though they will be free to receive any treatment for psychiatric or cardiac illness. Participants' outpatient providers will be informed of their psychiatric diagnosis, which may lead to higher-than-usual treatment for psychiatric illness.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Collaborative Care

2016

N/A

~1830

0 / 3Eligibility criteria met