Effects of Treatment of Chronic Stress in Patients With Lupus

Systemic Lupus Erythematosus Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00483613
• Other study ID #: 1-Alonso
• Status: Completed
• Phase: N/A
• First received: June 6, 2007
• Last updated: June 6, 2007
• Start date: December 2003
• Est. completion date: July 2005

Study information

• Verified date: June 2007
• Source: University Hospital Virgen de las Nieves
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: National System of Health
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: July 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Intervention

Behavioral:
• Cognitive-behavioral therapy of Meichenbaum

Locations

Country	Name	City	State
Spain	University Hospital Virgen de las Nieves	Granada	Spain/Granada

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Virgen de las Nieves

Country where clinical trial is conducted

Spain, 

References & Publications (2)

Peralta-Ramírez MI, Coín-Mejías MA, Jiménez-Alonso J, Ortego-Centeno N, Callejas-Rubio JL, Caracuel-Romero A, Pérez-García M. Stress as a predictor of cognitive functioning in lupus. Lupus. 2006;15(12):858-64. — View Citation

Peralta-Ramírez MI, Jiménez-Alonso J, Godoy-García JF, Pérez-García M; Group Lupus Virgen de las Nieves. The effects of daily stress and stressful life events on the clinical symptomatology of patients with lupus erythematosus. Psychosom Med. 2004 Sep-Oct;66(5):788-94. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Activity of the disease, quality of life		Initial, 3rd. month, 9th month, 15 th month
Secondary	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