Effects of Treatment of Chronic Stress in Patients With Lupus
| Tracking Information | |||||
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| First Received Date ICMJE | June 6, 2007 | ||||
| Last Updated Date | June 6, 2007 | ||||
| Start Date ICMJE | December 2003 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE |
Activity of the disease, quality of life [ Time Frame: Initial, 3rd. month, 9th month, 15 th month ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
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 ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Effects of Treatment of Chronic Stress in Patients With Lupus | ||||
| Official Title ICMJE | Not Provided | ||||
| Brief Summary |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care |
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| Condition ICMJE | Systemic Lupus Erythematosus | ||||
| Intervention ICMJE | Behavioral: Cognitive-behavioral therapy of Meichenbaum | ||||
| Study Arm (s) | Not Provided | ||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 45 | ||||
| Completion Date | July 2005 | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Spain | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00483613 | ||||
| Other Study ID Numbers ICMJE | 1-Alonso | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Not Provided | ||||
| Study Sponsor ICMJE | University Hospital Virgen de las Nieves | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | University Hospital Virgen de las Nieves | ||||
| Verification Date | June 2007 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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