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临床试验/NCT00663663
NCT00663663已完成不适用

Efficacy of Telephone-Delivered Cognitive Behavioral Therapy for Chronic Pain

University of Washington2 个研究点 分布在 1 个国家目标入组 207 人开始时间: 2009年9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
207
试验地点
2
主要终点
Average pain intensity

研究概览

简要总结

Treatments teaching people how to manage pain have been used to treat chronic pain in the general population. The purpose of this study is to see if these treatments delivered over the telephone can benefit persons with multiple sclerosis, spinal cord injury or an acquired amputation. Specifically, we want to determine if these treatments can help reduce the negative consequences that pain often causes in terms of a person's mood, daily activities, and enjoyment of life. We are also interested in finding out if these treatments decrease a person's pain.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Definitive diagnosis of acquired amputation (AMP), multiple sclerosis (MS), or spinal cord injury (SCI) confirmed by participants' primary care physicians
  • Average pain intensity in the past month of greater than 3 on 0-10 numeric rating scale;
  • Pain is either worse or started since the onset of the disability;
  • Pain of at least six months duration, with pain reportedly present greater than or equal to half of the days in the past six months;
  • Read, write and understand English;
  • Must be able to communicate over the phone (i.e., must be verbal);
  • Age 18 years or older.

排除标准

  • Cognitive impairment defined as one or more errors on the Six-Item screener (Callahan et al., 2002).
  • Current or previous participation in a psychological treatment for pain (obtained via self-report).
  • Current participation in a psychological treatment for any reason on a regular basis(obtained via self-report).

结局指标

主要结局

Average pain intensity

时间窗: Four times in a 7-day period Pre-Treatment, Mid-Treatment, Post-Treatment, and Follow-up (6 and 12 months post-randomization).

次要结局

  • Physical Functioning-Brief Pain Inventory (Cleeland & Ryan, 1994)(pre-treatment, mid-treatment, post-treatment, and follow-up (6 and 12 months post-randomization).)
  • Patient Health Questionnaire-8 (PHQ-8) (Kroenke & Spitzer, 2002)(pre-treatment, mid-treatment, post-treatment, and follow-up (6 and 12 months post-randomization).)
  • Pain Catastrophizing Scale (Sullivan et al., 1995)(pre-treatment, mid-treatment, post-treatment, and followup (6 and 12 months post-randomization))

研究者

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

Dawn Ehde

Principal Investigator

University of Washington

研究点 (2)

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