跳至主要内容
临床试验/NCT00483613
NCT00483613已完成不适用

Effects of Treatment of Chronic Stress in Patients With Lupus

University Hospital Virgen de las Nieves2 个研究点 分布在 1 个国家目标入组 45 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
45
试验地点
2
主要终点
Activity of the disease, quality of life

研究概览

简要总结

  • Daily stress can worsens the clinical course of lupus.
  • Objective: to determine the efficacy of the stress management therapy in a group of patients with lupus.
  • 45 patients with lupus and high daily stress participated in this clinical trial.
  • Two groups resulted: a control group (CG) that received the usual care and a therapy group (TG) that received a cognitive behavioral therapy.
  • The therapy consisted of ten consecutive weekly sessions.
  • The measured variables were psychological, clinical, immunological and quality of life. At the basal moment and after 3, 9 and 15 months.
  • Statistical analysis showed a significant reduction in the levels of depression, anxiety and daily stress in the therapy group, compared to the usual care group, a significant improvement in quality of life, improvements in the reported symptoms (cardiovascular, respiratory, cutaneous and musculoskeletal.

详细描述

Stress, especially daily stress, worsens the lupus symptoms perceived by the patients. Our objective was to determine the efficacy of the Meichenbaum stress management therapy for dealing with high daily stress in a group of patients with lupus.

We designed a randomized clinical trial in which 45 patients with lupus and daily stress participated. The patients were randomly assigned to one of the following groups: a) a control group (CG) that received the usual care and b) a therapy group (TG) that received a cognitive behavioral type therapy, performed by a group of 3 psychologists. Both groups were similar with regard to their sociodemographic, clinical, immunological, psychological aspects at the basal moment. The therapy consisted of ten consecutive weekly sessions. Psychological and emotional, clinical, immunological variables and quality of life were evaluated at the basal moment and after 3, 9 and 15 months.

The between-groups analysis showed a significant reduction in the levels of depression, anxiety and daily stress in the TG, compared to the CG, throughout the entire follow-up period, as well as a significant improvement in quality of life. The results also showed improvements in the reported symptoms (cardiovascular, respiratory, cutaneous and musculoskeletal) in the patients from the TG, who showed significant differences with regard to their basal level and in comparison with CG patients. This study shows the efficacy of the Meichenbaum stress management therapy in patients with lupus and high daily stress, as it significantly reduces the incidence of psychological disorders related to suffering from lupus, and it significantly improves and maintains their quality of life, in spite of the absence of a significant reduction in the illness activity index.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
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

  • SLE with at least 4 ACR criteria or patients with a diagnosis of CCL made with a biopsy
  • over 18 years of age
  • high levels of daily stress (defined in our population as equal to or greater than 24 points for men and 27 for women on the Cohen Perceived Stress Scale)

排除标准

  • less than a year of diagnosis of the disease
  • illiteracy
  • not being available to attend the intervention sessions or to perform the established analytic determinations
  • treatment for an acute psychiatric pathology

结局指标

主要结局

Activity of the disease, quality of life

时间窗: Initial, 3rd. month, 9th month, 15 th month

次要结局

  • Vulnerability to stress, amount of stress, depression, anxiety, SLEDAI index activity of lupus, somatic symptoms, number of clinical flares, antiADNn antibodies and levels of seric complement C3 and C4(Initial, 3rd month, 9th month, 15th month)

研究者

发起方
University Hospital Virgen de las Nieves
申办方类型
Other

研究点 (2)

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