Skip to main content
OpenTrials
Completed

NCT Number: NCT00847132

A Collaborative Care Program to Improve Depression Treatment in Cardiac Patients

Depression in cardiac patients is common, persistent, and deadly. However, the vast majority of cardiac patients with depression go unrecognized and untreated, despite the existence of treatments that clearly improve depressive symptoms and may favorably impact survival. Our research group and others have found that depression recognition and treatment appears particularly limited among patients with acute cardiac illness, though this population may be the most vulnerable to the deleterious effects of depression. We propose a project, building on successful collaborative care depression management programs in outpatient settings, to address this important issue.

The specific hypotheses behind the proposed research are that a collaborative care depression management program can be successfully adapted to inpatient cardiac units, and that such a program will lead to greater rates of adequate depression treatment and improvements in secondary outcomes.

The following specific aims capture the stepwise goals of this program:

1. To determine whether a collaborative care depression management program ('Enhanced Care') leads to significantly increased rates of adequate depression treatment compared to usual care (screening and feedback) (Primary Aim). 2. To assess whether this Enhanced Care program has a lasting impact on adequate depression treatment, depressive symptoms, health-related quality of life, and adherence to medical recommendations at 6 weeks, 12 weeks, and 6 months, compared to usual care.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Coronary Artery Disease Arrhythmia Arrhythmias, Cardiac Arterial Occlusive Diseases Arteriosclerosis Behavior Behavioral Symptoms Cardiovascular Diseases Congestive Heart Failure Coronary Disease Depression Heart Diseases Heart Failure Myocardial Ischemia Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Inpatient admission for cardiac diagnosis
  • Positive depression evaluation (PHQ-2>2, PHQ-9>9)
  • Ability to provide informed consent

Exclusion criteria

  • Active suicidal ideation
  • Bipolar disorder, psychotic disorder, active substance use disorder

Treatment and study plan

Collaborative care treatment

Behavioral

Depression education, treatment recommendations, coordination of care

usual care treatment

Behavioral

Treatment as usual, providers are notified of diagnoses

Primary outcomes

  1. Rates of Adequate Depression Treatment at Discharge

    Time frame: 5 days after enrollment

    Adequate treatment was defined a priori as either: (1) discharge prescription of an antidepressant at a clinically effective dose based on manufacturers' package labeling and treatment guidelines for the treatment of depression or (2) referral to a mental health treatment provider for psychotherapy (unless pre-planned as less than six sessions).

    Timeframe of "5 days after enrollment" was determined by calculating the median length of hospitalization for all subjects.

Secondary outcomes

  1. Change in Depression Symptoms From Baseline to 6 Months

    Time frame: Baseline, 6 weeks, 12 weeks, 6 months

    Depression symptoms measured by the Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 is a 9-item scale that measures depression severity. Each question asks how often the subject experiences symptoms of depression and offers four answers: 0 = Not at all, 1 = Several days, 2 = More than half the days, 3 = Nearly every day. Scores are totaled and range from 0-27. To be considered depressed, subjects had to (a) have a total score of 10 or more, (b) answer five questions with a score of 2 or 3, and (c) one of the five questions had to be question 1 or question 2 (or both). Anyone who did not meet these criteria were not considered depressed.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Feb 19, 2009
Registry last updated
Mar 31, 2017

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.