A Collaborative Care Program to Improve Depression Treatment in Cardiac Patients

Depression Clinical Trial

Official title:

A Collaborative Care Program to Improve Depression Treatment in Cardiac Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00847132
• Other study ID #: 2007P-001152
• Status: Completed
• Phase: N/A
• First received: February 17, 2009
• Last updated: November 29, 2010
• Start date: July 2007
• Est. completion date: June 2010

Study information

• Verified date: November 2010
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 175
• Est. completion date: June 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Arrhythmia
• Congestive Heart Failure
• Coronary Artery Disease
• Coronary Disease
• Depression
• Depressive Disorder
• Heart Failure
• Myocardial Ischemia

Intervention

Behavioral:
• Collaborative care vs. usual care
depression education, treatment recommendations, coordination of care

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rates of adequate depression treatment at discharge		hospital discharge	No
Secondary	Depressive symptoms		6 months	No