Effects of Treatment of Chronic Stress in Patients With Lupus
|ClinicalTrials.gov Identifier: NCT00483613|
Recruitment Status : Completed
First Posted : June 7, 2007
Last Update Posted : June 7, 2007
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Systemic Lupus Erythematosus||Behavioral: Cognitive-behavioral therapy of Meichenbaum||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||45 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Study Start Date :||December 2003|
|Actual Study Completion Date :||July 2005|
- Activity of the disease, quality of life [ Time Frame: Initial, 3rd. month, 9th month, 15 th month ]
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00483613
|University Hospital Virgen de las Nieves|
|Granada, Spain/Granada, Spain, 18012|
|Principal Investigator:||Jiménez Juan, PhD, MD|