Depression Outpatient Cardiology Screening Study (DOCS)

Randomized Controlled Trial of Screening for Depression in Cardiac Outpatients

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.

Study Overview

• Status: Completed
• Conditions: Depression; Coronary Heart Disease
• Intervention / Treatment: Behavioral: Collaborative Care

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.

• Study Type: Interventional
• Enrollment (Actual): 201
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • St. Louis, Missouri, United States, 63108
      • Behavioral Medicine Center at Washington University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual Care (UC); Patients will receive only the care provided by their primary care physicians or other medical professionals outside of the study.
Experimental: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Beck Depression Inventory 2	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.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment Satisfaction Scale.	This one item scale asks patients to rate their satisfaction with their depression treatment on a one (very dissatisfied) to 5 (very satisfied) scale.	12 months
PROMIS Physical Functioning Scale 10a Short Form	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.	12 months

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Collaborators: Agency for Healthcare Research and Quality (AHRQ)
• Investigators: Principal Investigator: Robert M. Carney, PhD, Washington University School of Medicine

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): July 1, 2016
• Study Completion (Actual): July 1, 2016

Study Registration Dates

• First Submitted: March 9, 2012
• First Submitted That Met QC Criteria: March 9, 2012
• First Posted (Estimate): March 13, 2012

Study Record Updates

• Last Update Posted (Actual): April 27, 2017
• Last Update Submitted That Met QC Criteria: March 16, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Cardiovascular Diseases; Vascular Diseases; Mood Disorders; Arteriosclerosis; Arterial Occlusive Diseases; Heart Diseases; Depression; Depressive Disorder; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: 201105510

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO