Ignite Creation Date:
2024-05-05 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00483613
Status:
COMPLETED
Last Update Posted:
2007-06-07
First Post:
2007-06-06
Brief Title:
Effects of Treatment of Chronic Stress in Patients With Lupus
Sponsor:
University Hospital Virgen de las Nieves
Organization:
University Hospital Virgen de las Nieves
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2007-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None