Depression Outpatient Cardiology Screening Study

Depression Clinical Trial

— DOCS  

Official title:

Randomized Controlled Trial of Screening for Depression in Cardiac Outpatients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01552889
• Other study ID #: 201105510
• Status: Completed
• Phase: N/A
• First received: March 9, 2012
• Last updated: September 1, 2016
• Start date: January 2012
• Est. completion date: July 2016

Study information

• Verified date: September 2016
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 201
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Depression
• Depressive Disorder
• Heart Diseases
• Myocardial Ischemia

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Behavioral Medicine Center at Washington University	St. Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	Agency for Healthcare Research and Quality (AHRQ)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Beck Depression Inventory score		12 months	No
Secondary	Treatment Satisfaction Scale		12 months	No
Secondary	PROMIS physical functioning		12 months	No