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临床试验/NCT00618475
NCT00618475已完成不适用

Cognitive Behavioral Treatment of Depression in ESRD Patients on Dialysis

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)2 个研究点 分布在 1 个国家目标入组 65 人开始时间: 2008年8月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
65
试验地点
2
主要终点
Beck Depression Inventory

研究概览

简要总结

Depression is second in frequency only to hypertension as a comorbid condition for End Stage Renal Disease (ESRD) patients. The presence of depression has been linked to lower quality of life, more medical comorbidities and shorter lifespan. This project represents the first known attempt at a standardized intervention for depression in ethnically diverse ESRD patients. The study will be conducted at the Parkside Center for Dialysis. Patients will be randomly selected for screening until 80 subjects meet entry criteria and agree to be randomized. Once subjects are screened and enrolled in the study they are randomly assigned to either a treatment or wait-list control condition. After 3 months, the intervention will be completed and both groups will be reassessed. After an additional 3 months, both groups will have received the intervention and pre and post measures for both groups will be available as well as 3 month follow-up for the 1st intervention group.

The following measures will be collected: to obtain a full DSM-IV diagnosis the SCID I and SCID II will be utilized. The BDI will provide a self-report measure of depression. The Hospital Anxiety and Depression Scale (HADS), a measure designed specifically for medically ill patients, will also be administered. Additionally, the Young Schema Questionnaire, a measure which seeks to identify maladaptive (both depressive and anxious) cognitive styles, will be administered. A quality of life measure designed specifically for dialysis patients (KDQOL-SF) will also be given as a means of measuring patient's overall coping and functioning. To better understand the patient's perceptions of their health and illness the Illness Effects Questionnaire will be administered. A demographic information sheet will be completed by the subject in which personal, ethnic, and illness information is collected. Detailed information about the subject's mental health history and treatment as well as current medications will be gathered. Data from routine dialysis laboratories (hemoglobin, creatinine, albumin, Kt/V) will be extracted from the chart.

The intervention will take place in individual format while the subjects are being dialyzed. The intervention will be 10 sixty minute -long weekly sessions spread over not more than 3 months. It will include both cognitive and behavioral skills focused on alleviating depressive affect and identifying maladaptive patterns of thought and behavior. This study would lay the groundwork for future clinical research by helping to develop a culturally competent clinical intervention and demonstrate the feasibility and effectiveness of adapting psychosocial intervention for a medically complex culturally diverse population.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • hemodialysis patient Depression diagnosis

排除标准

  • (1) presence of current organic mental disorder (2) schizophrenia (3) bipolar disorder (4) depression with psychotic features (5) current substance abuse or dependence (6) active suicidal intent or plan (7) active homicidal ideation, intent, or plan -

研究组 & 干预措施

Treatment

Experimental

Individual cognitive behavioral therapy (CBT)

干预措施: Cognitive behavioral therapy (Behavioral)

Wait-list control

Other

Individual cognitive behavioral therapy (CBT) after 3 month wait-list period

干预措施: Cognitive behavioral therapy (Behavioral)

结局指标

主要结局

Beck Depression Inventory

时间窗: baseline, completion, 3 month follow-up

次要结局

  • Quality of Life(baseline, completion, 3 month follow-up)
  • Clinical biomarkers(baseline, completion, 3 month follow-up)

研究者

研究点 (2)

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