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临床试验/NCT00149760
NCT00149760已完成2 期

Cognitive Affective Behavior Therapy for Somatization

Rutgers, The State University of New Jersey1 个研究点 分布在 1 个国家目标入组 88 人开始时间: 2003年8月1日最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
已完成
入组人数
88
试验地点
1
主要终点
Clinical Global Impression Scale for Somatization Disorder

研究概览

简要总结

This study will examine the long-term effect of cognitive-affective behavior therapy on the physical symptoms, functioning, and health care utilization of people with somatization disorder.

详细描述

Somatization disorder is a syndrome characterized by the presence of multiple medically unexplained physical symptoms. It often results in substantial functional impairment and the need for extensive medical treatment. Neither pharmacological nor psychosocial treatments for the disease have demonstrated clinical success. People with somatization disorder may benefit from a treatment that integrates emotion-centered strategies into cognitive behavioral therapy. The long-term effectiveness of this treatment has not been established, however. This study will examine the long-term effect of cognitive-affective behavior therapy 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 cognitive-affective behavior therapy (CABT) or standard medical care that is augmented by a psychiatric consultation. Treatment will last 4 months. Assessments of somatic symptomatology, functional impairment, and health care costs will occur at screening, baseline (1 to 2 weeks after screening), and 4, 10, and 16 months after baseline. The visits at 10 and 16 months post-baseline 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
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Meets DSM-IV criteria for somatization disorder
  • •Available for follow-up over the ensuing 18 months
  • •English-speaking

排除标准

  • •Meets DSM-IV criteria for a psychotic disorder, organic brain syndrome, or psychoactive substance dependence (Other psychiatric comorbidity is not exclusionary)
  • •Active suicidal ideation
  • •Unstable major medical condition
  • •Plans to engage in additional psychotherapy during the first 6 months after enrollment
  • •Current use of any medication that has not been stabilized for the previous 2 months

研究组 & 干预措施

Augmented Standard Medical Care

Active Comparator

Participants will receive standard medical care augmented by a psychiatric consultation letter sent to the participants' primary care physician.

干预措施: Augmented Standard Medical Care (Behavioral)

Cognitive-Affective Behavior Therapy

Experimental

Participants will receive individually administered cognitive-affective behavior therapy as well as augmented standard medical care.

干预措施: Cognitive-Affective Behavior Therapy (Behavioral)

结局指标

主要结局

Clinical Global Impression Scale for Somatization Disorder

时间窗: Measured at baseline and Months 4, 10, and 16

次要结局

  • Physical functioning(Measured at baseline and Months 4, 10, and 16)
  • Health care utilization(Measured between Months 4 and 16)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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