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临床试验/NCT02683278
NCT02683278已完成不适用

Fibromyalgia: Interventions for Pain and Mood Regulation

Arizona State University0 个研究点目标入组 170 人开始时间: 2008年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
170
主要终点
Bodily Pain

研究概览

简要总结

This study compares the impact of cognitive-behavioral therapy for pain (CBT-P), mindful awareness and acceptance treatment (M), and arthritis education as an active control condition (E) on mental and physical health outcomes among adults with chronic pain due to fibromyalgia (FM).

详细描述

Both cognitive-behavioral and mindful-acceptance based treatments impact pain and disability in people with chronic pain conditions like fibromyalgia. However, these treatments target different mechanisms. The focus of CBT is on helping individuals manage their thoughts and behaviors related to pain. In contrast, the focus of M is on improving individuals' ability be aware of and accept their experiences, and to develop their positive emotional resources.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Pain in at least 11 of 18 tenderpoints
  • Able to participate in study assessments and group-based meetings
  • Willing to be randomized to treatment condition

排除标准

  • Unable to understand written and spoken English
  • Involved in pain-related litigation
  • Currently involved in psychological treatment for pain and/or mood symptoms

结局指标

主要结局

Bodily Pain

时间窗: Change from baseline, 6-mo followup, and 12-mo followup

Assessed via the SF-36 Bodily Pain subscale (Reference: Ware JE, Sherbourne CD. The MOS 36-Item Short-Form Health Survey (SF-36): I. conceptual framework and item selection. Med Care 1992; 30(6):473-83.

Depressive symptoms

时间窗: Change from baseline, 6-mo followup, 12-mo followup

Assessed via the Hamilton Depression Inventory (Reference: Reynolds WM, Kobak KA. Reliability and validity of the Hamilton Depression Inventory: A paper-and-pencil version of the Hamilton Depression Rating Scale Clinical Interview. Psychological Assessment 1995; 7(4): 472-83.

Physical Functioning

时间窗: Change from baseline, 6-mo followup, and 12-mo followup

Assessed via the SF-36 physical functioning subscale (Reference: Ware JE, Sherbourne CD. The MOS 36-Item Short-Form Health Survey (SF-36: I. conceptual framework and item selection. Med Care 1992; 30(6):473-83.

Vitality

时间窗: Change from baseline, 6-mo followup, and 12-mo followup

Assessed via the SF-36 Vitality subscale (Reference: Ware JE, Sherbourne CD. The MOS 36-Item Short-Form Health Survey (SF-36): I. conceptual framework and item selection. Med Care 1992; 30(6):473-83.

Social Functioning

时间窗: Change from baseline, 6-mo followup, and 12-mo followup

Assessed via the SF-36 Social Functioning subscale (Reference: Ware JE, Sherbourne CD. The MOS 36-Item Short-Form Health Survey (SF-36): I. conceptual framework and item selection. Med Care 1992; 30(6):473-83.

次要结局

未报告次要终点

研究者

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

Mary Davis

Professor

Arizona State University

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