Effects of Treatment of Chronic Stress in Patients With Lupus

This study has been completed.
Sponsor:
Information provided by:
University Hospital Virgen de las Nieves
ClinicalTrials.gov Identifier:
NCT00483613
First received: June 6, 2007
Last updated: NA
Last verified: June 2007
History: No changes posted

June 6, 2007
June 6, 2007
December 2003
Not Provided
Activity of the disease, quality of life [ Time Frame: Initial, 3rd. month, 9th month, 15 th month ]
Same as current
No Changes Posted
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 [ Time Frame: Initial, 3rd month, 9th month, 15th month ]
Same as current
Not Provided
Not Provided
 
Effects of Treatment of Chronic Stress in Patients With Lupus
Not Provided
  • 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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Systemic Lupus Erythematosus
Behavioral: Cognitive-behavioral therapy of Meichenbaum
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
45
July 2005
Not Provided

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT00483613
1-Alonso
Yes
Not Provided
University Hospital Virgen de las Nieves
Not Provided
Principal Investigator: Jiménez Juan, PhD, MD
University Hospital Virgen de las Nieves
June 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP