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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
  Purpose
  • 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 Intervention
Systemic Lupus Erythematosus
 Behavioral: Cognitive-behavioral therapy of Meichenbaum

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital Virgen de las Nieves:

Primary Outcome Measures:
  • Activity of the disease, quality of life [ Time Frame: Initial, 3rd. month, 9th month, 15 th month ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 45
Study Start Date: December 2003
Study Completion Date: July 2005
Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00483613

Locations
Spain
University Hospital Virgen de las Nieves
Granada, Spain/Granada, Spain, 18012
Sponsors and Collaborators
University Hospital Virgen de las Nieves
Investigators
Principal Investigator: Jiménez Juan, PhD, MD
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00483613     History of Changes
Other Study ID Numbers: 1-Alonso
Study First Received: June 6, 2007
Last Updated: June 6, 2007
Health Authority: Spain: National System of Health

Keywords provided by University Hospital Virgen de las Nieves:
Daily stress
Cognitive-behavioral therapy
Quality of life
SLEDAI

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on June 17, 2013