Effects of Treatment of Chronic Stress in Patients With Lupus
Primary Purpose
Systemic Lupus Erythematosus
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Cognitive-behavioral therapy of Meichenbaum
Sponsored by
About this trial
This is an interventional supportive care trial for Systemic Lupus Erythematosus focused on measuring Daily stress, Cognitive-behavioral therapy, Quality of life, SLEDAI
Eligibility 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
Sites / Locations
- University Hospital Virgen de las Nieves
Outcomes
Primary Outcome Measures
Activity of the disease, quality of life
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
Full Information
NCT ID
NCT00483613
First Posted
June 6, 2007
Last Updated
June 6, 2007
Sponsor
University Hospital Virgen de las Nieves
1. Study Identification
Unique Protocol Identification Number
NCT00483613
Brief Title
Effects of Treatment of Chronic Stress in Patients With Lupus
Study Type
Interventional
2. Study Status
Record Verification Date
June 2007
Overall Recruitment Status
Completed
Study Start Date
December 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University Hospital Virgen de las Nieves
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Lupus Erythematosus
Keywords
Daily stress, Cognitive-behavioral therapy, Quality of life, SLEDAI
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Cognitive-behavioral therapy of Meichenbaum
Primary Outcome Measure Information:
Title
Activity of the disease, quality of life
Time Frame
Initial, 3rd. month, 9th month, 15 th month
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jiménez Juan, PhD, MD
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Virgen de las Nieves
City
Granada
State/Province
Spain/Granada
ZIP/Postal Code
18012
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
15385708
Citation
Peralta-Ramirez MI, Jimenez-Alonso J, Godoy-Garcia JF, Perez-Garcia 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. doi: 10.1097/01.psy.0000133327.41044.94.
Results Reference
background
PubMed Identifier
17211991
Citation
Peralta-Ramirez MI, Coin-Mejias MA, Jimenez-Alonso J, Ortego-Centeno N, Callejas-Rubio JL, Caracuel-Romero A, Perez-Garcia M. Stress as a predictor of cognitive functioning in lupus. Lupus. 2006;15(12):858-64. doi: 10.1177/0961203306071404.
Results Reference
result
Learn more about this trial
Effects of Treatment of Chronic Stress in Patients With Lupus
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