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临床试验/NCT00276887
NCT00276887已完成2 期

Cognitive Behavior Therapy for Somatization Disorder

University of Medicine and Dentistry of New Jersey2 个研究点 分布在 1 个国家目标入组 84 人开始时间: 1999年9月最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
84
试验地点
2
主要终点
Symptoms of somatization disorder

研究概览

简要总结

This study will examine the long-term effects of cognitive behavioral therapy on the physical symptoms, functioning, and health care utilization of people with multiple medically unexplained physical symptoms.

详细描述

Somatization disorder is a chronic psychological condition that causes numerous physical complaints for which no underlying physical problem can be identified. The disorder often lasts for several years and results in substantial functional impairment. The physical complaints most frequently involve chronic pain and problems with the digestive, nervous, and reproductive systems. Neither pharmacological nor psychosocial treatments for this disorder have been successful in suppressing symptoms. Cognitive behavioral therapy (CBT) is a treatment that focuses on maladaptive patterns of thinking and the beliefs that underlie such thinking. This study will examine the long-term effects of CBT on the physical symptoms, functioning, and health care utilization of people with somatization disorder.

Participants in this open label study will be randomly assigned to receive either CBT supplemented with augmented standard medical care (ASMC) as indicated by a psychiatric consultation letter or ASMC alone. Participants assigned to CBT plus ASMC will receive CBT for 10 weeks. Somatic symptomatology, functional impairment, and health care costs will be assessed at study visits at baseline and Months 3, 9, and 15. The visits at Months 9 and 15 will assess specifically the long-term efficacy of the treatment.

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
None

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

  • Meets DSM-IV criteria for somatization disorder
  • Available for follow-up over the ensuing 15 months
  • English-speaking

排除标准

  • Meets DSM-IV criteria for a psychotic disorder, organic brain syndrome, or psychoactive substance dependence
  • Active suicidal ideation
  • Unstable major medical condition
  • Plans to engage in additional psychotherapy during the first 3 months after study entry
  • Current use of any medication that has not been stabilized for the 2 months prior to study entry

结局指标

主要结局

Symptoms of somatization disorder

Functioning (measured with the Clinical Global Impression Scale for Somatization Disorder at Months 9 and 15)

次要结局

  • Health care utilization (measured the year before baseline and during the year after the 3-month assessment)
  • Health status (measured by the Medical Outcomes Study, SF-36, at Months 9 and 15)

研究者

研究点 (2)

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