跳至主要内容
临床试验/NCT00268606
NCT00268606已完成不适用

Tailored Cognitive-Behavioral Therapy for Fibromyalgia Patients at Risk: A Randomized, Controlled Trial

ZonMw: The Netherlands Organisation for Health Research and Development5 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2003年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
400
试验地点
5
主要终点
pain

研究概览

简要总结

The present study is a new approach of examining tailored cognitive-behavioral interventions for fibromyalgia patients at risk. For this purpose, fibromyalgia patients are screened with respect to cognitive-behavioral risk factors and these patients are offered tailored cognitive-behavioral treatment options. It is expected that this approach will result in increased magnitude and maintenance of effects.

详细描述

The fibromyalgia syndrome is a chronic condition with widespread pain that poses a great challenge for patients, rheumatologists and society because of the lack of optimal treatment options. There is extensive evidence that, in comparison with patients with rheumatoid arthritis, fibromyalgia patients report higher levels of functional disability, pain, fatigue, and lower levels of quality of life. Although effectiveness of pharmacological agents and other interventions is generally limited, most promising effects have been found for non-pharmacological treatments, particularly those with a primary focus on cognitive-behavioral treatment components. However, also these treatment outcomes are characterized by large individual variation. Particularly patients with less impairments in daily life seem to benefit less from these treatments. In line with the international literature, previous findings of the research group suggest that effectiveness might be increased when tailored cognitive-behavioural treatments are solely offered to patients at risk.

In the present project the effects of tailored interventions based on cognitive-behavioral factors for patients at risk are studied. In a randomized, controlled trial, fibromyalgia patients are screened for risk profiles. Patients at risk will be assigned to tailored cognitive or behavioral treatment conditions, depending on their risk profile with respect to cognitive-behavioral factors. Half of the patients are subsequently randomly assigned to a waiting list control condition. It is expected that this tailored treatment approach will increase magnitude and maintenance of treatment effects for pain, disability, fatigue and increased quality of life, which means an important step forward for patients, involved professionals and society.

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
否

入选标准

  • •fibromyalgia according to the criteria of the American College of Rheumatology (ACR)

排除标准

  • •physical or psychological comorbidity that interferes with cognitive-behavioral treatment
  • •participation in other clinical trials
  • •other psychological treatments
  • •pregnancy
  • •illiteracy
  • •difficulties with understanding Dutch language

结局指标

主要结局

pain

disability

fatigue

psychological distress at post treatment and 6 month follow-up

次要结局

  • passive coping
  • illness cognitions
  • social support at post treatment and 6 month follow-up

研究者

发起方
ZonMw: The Netherlands Organisation for Health Research and Development
申办方类型
Other

研究点 (5)

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