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Depression Outpatient Cardiology Screening Study (DOCS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Washington University School of Medicine
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Robert Carney, Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01552889
First received: March 9, 2012
Last updated: May 27, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Depression
Coronary Heart Disease
Behavioral: Collaborative Care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of Screening for Depression in Cardiac Outpatients

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • Beck Depression Inventory score [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Treatment Satisfaction Scale [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • PROMIS physical functioning [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: January 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01552889

Contacts
Contact: Diane Salamon, RN 314-286-1327 salamond@bmc.wustl.edu

Locations
United States, Missouri
Behavioral Medicine Center at Washington University Recruiting
St. Louis, Missouri, United States, 63108
Principal Investigator: Robert M. Carney, PhD         
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Robert M. Carney, PhD Washington University School of Medicine
  More Information

No publications provided

Responsible Party: Robert Carney, Professor of Psychiatry, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01552889     History of Changes
Other Study ID Numbers: 201105510
Study First Received: March 9, 2012
Last Updated: May 27, 2014
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Depression
Depressive Disorder
Heart Diseases
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Behavioral Symptoms
Cardiovascular Diseases
Mental Disorders
Mood Disorders
Vascular Diseases

ClinicalTrials.gov processed this record on November 27, 2014