Effects of Treatment of Chronic Stress in Patients With Lupus

Systemic Lupus Erythematosus Clinical Trial

Status Completed

Clinical Trial Summary

• 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.

Clinical Trial Description

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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

• NCT number: NCT00483613
• Study type: Interventional
• Source: University Hospital Virgen de las Nieves
• Status: Completed
• Phase: N/A
• Start date: December 2003
• Completion date: July 2005