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Completed

NCT Number: NCT01552889

Depression Outpatient Cardiology Screening Study

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.

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Key information

Conditions

Depression Behavior Behavioral Symptoms Cardiovascular Diseases Coronary Disease Coronary Heart Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Behavioral Medicine Center at Washington University

St Louis, Missouri, 63108, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

collaborative care

Behavioral

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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • Agency for Healthcare Research and Quality (AHRQ)

Registry information

Official study title

Randomized Controlled Trial of Screening for Depression in Cardiac Outpatients

Acronym: DOCS

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Mar 13, 2012
Registry last updated
Apr 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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