Depression Outpatient Cardiology Screening Study

Not Applicable

Completed

• Conditions: Depression; Coronary Heart Disease
• Interventions: Behavioral: Collaborative Care

• Registration Number: NCT01552889
• Lead Sponsor: Washington University School of Medicine

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-03-09
• Study First Submitted QC: 2012-03-09
• Study First Posted: 2012-03-13
• Primary Completion: 2016-07
• Study Completion: 2016-07
• Results First Submitted: 2017-01-25
• Status Verified: 2017-03
• Results First Submitted QC: 2017-03-16
• Last Update Submitted: 2017-03-16
• Results First Posted: 2017-04-27
• Last Update Posted: 2017-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 201

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Collaborative Care (CC)	Collaborative Care	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.

Primary Outcome Measures

Name	Time	Method
Beck Depression Inventory 2	12 months	Self report depression symptom inventory. Scale ranges from 0-63. The higher the score the more depression symptoms. A score of 12 or greater is considered to indicate a clinically significant depression.

Secondary Outcome Measures

Name	Time	Method
Treatment Satisfaction Scale.	12 months	This one item scale asks patients to rate their satisfaction with their depression treatment on a one (very dissatisfied) to 5 (very satisfied) scale.
PROMIS Physical Functioning Scale 10a Short Form	12 months	This is a 10 item questionnaire that assesses the respondent's ability to perform common physical activities as rated on a 1-5 scale. The total score is converted to a T score which expresses where the individual ranks relative to the reference group.

Trial Locations

Locations (1)

Behavioral Medicine Center at Washington University; 🇺🇸 St. Louis, Missouri, United States