Depression Outpatient Cardiology Screening Study

NCT ID: NCT01552889

Last Updated: 2017-04-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 201 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2016-07-31

Brief Summary

This study compares the effects of depression screening and case management to usual care in cardiology outpatients with documented evidence of coronary heart disease. Despite strong evidence that depression is a risk factor for cardiac events, there is insufficient evidence to support the use of depression screening in cardiac patients.

Detailed Description

Depression and cardiovascular disease are highly comorbid, and depression is a risk factor for psychosocial morbidity, poor adherence to medical treatment regimens, physical inactivity, poor physical functioning, and medical morbidity and mortality in cardiac patients, especially following an acute coronary syndrome (ACS). The American Heart Association recently recommended that all cardiac patients be screened for depression in order to improve identification and treatment of this risk factor.

Patients are screened for depression during an outpatient cardiology visit and those that screen positive will be contacted for enrollment into this study. Patients are then randomized to receive collaborative care involving the patient, the patient's primary care physician (PCP), the cardiologist and the nurse case manager, or usual care (the patient is informed he/she screened positive for depression and is advised to contact their PCP and/or cardiologist). The PCP and/or cardiologist are free to evaluate, treat and refer that patient to mental health services as they deem necessary.

Patients in both groups will be monitored for depression severity and duration at 3, 6 and 12 months after enrollment. The course of their depression since enrollment or last follow-up includes remissions, new onsets, relapses, recurrences, and treatment will be determined.

Conditions

Depression; Coronary Heart Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Usual Care (UC)

Patients will receive only the care provided by their primary care physicians or other medical professionals outside of the study.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Collaborative Care (CC)

Patients randomized to the Collaborate Care (CC) arm of this study will receive brief screening, consultative, and referral services. This collaborative approach includes the patient, the patient's PCP, the cardiologist, and the nurse case manager (NCM), using evidence based recommendations for depression treatment and follow-up care.

Group Type: EXPERIMENTAL

Collaborative Care

Intervention Type: BEHAVIORAL

No direct treatment will be offered. We will make treatment recommendations to the patient, PCP and cardiologist. Referral to mental health specialist is also possible, depending on need. The nurse case manager will monitor treatment progress and patient status for duration of the intervention period.

Interventions

Collaborative Care

No direct treatment will be offered. We will make treatment recommendations to the patient, PCP and cardiologist. Referral to mental health specialist is also possible, depending on need. The nurse case manager will monitor treatment progress and patient status for duration of the intervention period.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• recent history of Acute Coronary Syndrome or other cardiac event or documented heart disease
• score of 10 or higher on the Patient Health Questionnaire

Exclusion Criteria

• suicidal ideation or behavior
• cognitive impairment or inability to read or speak English
• schizophrenia, bipolar disorder
• active substance abuse or alcoholism
• severe valvular disease, severe congestive heart failure, malignancy
• physical limitations that would interfere with participation in the study
• medical contraindications to the use of available antidepressants
• participation in a competing research protocol
• physician or patient refusal

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Agency for Healthcare Research and Quality (AHRQ)

FED

Sponsor Role: collaborator

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Robert Carney

Professor of Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Robert M. Carney, PhD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

Behavioral Medicine Center at Washington University

St Louis, Missouri, United States

Countries

United States

Other Identifiers

201105510

Identifier Type: -

Identifier Source: org_study_id