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临床试验/NCT00050583
NCT00050583已完成3 期

Treatment of Somatization in Primary Care

University of Medicine and Dentistry of New Jersey2 个研究点 分布在 1 个国家目标入组 172 人开始时间: 2001年2月最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
入组人数
172
试验地点
2
主要终点
CGI Improvement

研究概览

简要总结

The purpose of this study is to compare cognitive behavior therapy (CBT) to medical care-as-usual for the treatment of patients with high levels of medically unexplained physical symptoms (Somatization Disorder). A second goal is to examine the effectiveness of CBT in Latinos, since Latinos suffer a relatively high prevalence of Somatization Disorder.

详细描述

Patients with Somatization Disorder suffer from medically unexplained physical ailments and experience significant distress and disability. This disorder is an important problem for the primary health care system because patients with Somatization Disorder use health care resources extensively but receive little benefit. To date, no medical or psychiatric intervention has been demonstrated in controlled trials to produce clinically significant and lasting symptom relief or improved functional status in Somatization Disorder patients.

Patients in primary care settings with multiple unexplained symptoms are treated with 10 weekly sessions of CBT or "treatment as usual." Physical symptoms, comorbid psychiatric symptoms, disability, and health care utilization are measured and assessed through a combination of structured interviews and self-reports. Assessments are performed at study start, mid-treatment, end of treatment, and at a 6-month follow-up.

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
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Somatization disorder

排除标准

  • Bipolar disorder
  • Schizophrenia or other psychosis
  • Major Depression

结局指标

主要结局

CGI Improvement

时间窗: Post Treatment

次要结局

  • Hamilton Depression(Post Treatment)

研究者

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

Javier I Escobar MD

Associate Dean for Global Health

Rutgers, The State University of New Jersey

研究点 (2)

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