Depression Outpatient Cardiology Screening Study (DOCS)

The Washington University

Status: Completed

Conditions: Coronary Heart Disease; Depression

Treatments: Behavioral: Collaborative Care

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT01552889

201105510

Details and patient eligibility

About

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.

Full 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.

Enrollment: 201 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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201 participants in 2 patient groups

Usual Care (UC)

No Intervention group

Description:

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

Collaborative Care (CC)

Experimental group

Description:

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.

Treatment:

Behavioral: Collaborative Care