Treatment of Somatization in Primary Care
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
- 否
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
Javier I Escobar MD
Associate Dean for Global Health
Rutgers, The State University of New Jersey
