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Trial record 31 of 229 for:    "Depressive Disorder" [DISEASE] | ( Map: Missouri, United States )

Depression Outpatient Cardiology Screening Study (DOCS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01552889
Recruitment Status : Completed
First Posted : March 13, 2012
Results First Posted : April 27, 2017
Last Update Posted : April 27, 2017
Agency for Healthcare Research and Quality (AHRQ)
Information provided by (Responsible Party):
Robert Carney, 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.

Condition or disease Intervention/treatment Phase
Depression Coronary Heart Disease Behavioral: Collaborative Care Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 201 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of Screening for Depression in Cardiac Outpatients
Study Start Date : January 2012
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

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.

Primary Outcome Measures :
  1. Beck Depression Inventory 2 [ Time Frame: 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 :
  1. Treatment Satisfaction Scale. [ Time Frame: 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.

  2. PROMIS Physical Functioning Scale 10a Short Form [ Time Frame: 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01552889

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United States, Missouri
Behavioral Medicine Center at Washington University
St. Louis, Missouri, United States, 63108
Sponsors and Collaborators
Washington University School of Medicine
Agency for Healthcare Research and Quality (AHRQ)
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Principal Investigator: Robert M. Carney, PhD Washington University School of Medicine

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Responsible Party: Robert Carney, Professor of Psychiatry, Washington University School of Medicine Identifier: NCT01552889     History of Changes
Other Study ID Numbers: 201105510
First Posted: March 13, 2012    Key Record Dates
Results First Posted: April 27, 2017
Last Update Posted: April 27, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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