Clinical trial NCT01552889: Depression Outpatient Cardiology Screening Study
Official title: Randomized Controlled Trial of Screening for Depression in Cardiac Outpatients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Coronary Heart Disease
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2012-03-13
Enrollment: 201
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Beck Depression Inventory 2
timeFrame: 12 months
Secondary outcomes:
measure: Treatment Satisfaction Scale.
timeFrame: 12 months
measure: PROMIS Physical Functioning Scale 10a Short Form
timeFrame: 12 months
Other outcomes:
Locations:
city: St. Louis
country: United States
facility: Behavioral Medicine Center at Washington University
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Robert M. Carney, PhD
role: PRINCIPAL_INVESTIGATOR
References: