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临床试验/NCT01284751
NCT01284751已完成不适用

The Use of Major Depression Inventory (MDI) in Measuring Preoperative Depressive Symptoms in Breast Cancer Patients

Herlev Hospital1 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2011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
21
试验地点
1
主要终点
Depressive symptoms

研究概览

简要总结

The purpose of this study is to measure depressive symptoms in breast cancer patients before surgery with Major Depression Inventory (MDI). The investigators hypothesize that this patient group will not produce scores correlating to having a mild, moderate or severe depression even though they have just recently experienced a major life crisis by receiving a malignant diagnosis.

详细描述

The Major Depression Inventory is a self-rating depression scale with 12 questions. The questionnaire has previously been investigated in a Danish population. The scale contains the 10 ICD-10 (International Classification of Diseases)symptoms of depression and these symptoms are identical with the DSM-IV major depression symptoms with the exception of one symptom, low self-esteem, which in DSM-IV (Diagnostic and Statistical Manual of Mental Disorders) is incorporated in the symptom of guilt. On a six-point Likert scale, the individual items measure how much of the time the symptoms have been present during the last 14 days. The MDI is then scored according to specific guidelines and can be used as both a rating scale and a diagnostic instrument.

Patients will approximately one week after the diagnosis of breast cancer has been made, corresponding to approximately one week before surgery, be asked to complete the MDI. Patients therefore only complete the MDI once in the whole study. At the same time a Mini Mental State Examination (MMSE) and questions regarding previous illnesses and medication will be asked. Patients will not be followed up in any way.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
30 Years 至 70 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Women aged 30-70 years old, who are undergoing a lumpectomy or mastectomy
  • ASA I-III

排除标准

  • Planned or ongoing preoperative chemotherapy
  • Known and treated sleep apnea syndrome
  • Insulin treated diabetes mellitus
  • Known or previous treated depressive illness or bipolar disorder
  • Known autoimmune disease
  • Incompensated cirrhosis
  • Other previous or ongoing cancer
  • Known medically treated sleep disorder (insomnia, restless legs etc)
  • Shift-work or night-work
  • Daily alcohol intake of more than 5 units
  • Preoperative treatment with psychopharmacological drugs, opioids or anxiolytics
  • Predicted bad compliance
  • Pregnant or breast feeding
  • Preoperative MMSE score less than 24

结局指标

主要结局

Depressive symptoms

时间窗: Approximately one week before surgery

Total score on the Major Depression Inventory. When used as a diagnostic instruemtn patients witll according to the ICD-10 algorhythym be classified as mild, moderate or severe depression or no depression.

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (1)

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