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临床试验/NCT01552889
NCT01552889已完成不适用

Randomized Controlled Trial of Screening for Depression in Cardiac Outpatients

Washington University School of Medicine2 个研究点 分布在 1 个国家目标入组 201 人开始时间: 2012年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
201
试验地点
2
主要终点
Beck Depression Inventory 2

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
21 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • recent history of Acute Coronary Syndrome or other cardiac event or documented heart disease
  • score of 10 or higher on the Patient Health Questionnaire

排除标准

  • 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

结局指标

主要结局

Beck Depression Inventory 2

时间窗: 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.

次要结局

  • Treatment Satisfaction Scale.(12 months)
  • PROMIS Physical Functioning Scale 10a Short Form(12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Robert Carney

Professor of Psychiatry

Washington University School of Medicine

研究点 (2)

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