Effects of Treatment of Chronic Stress in Patients With L... | NCT00483613

Studies
Effects of Treatment of Chronic Stress in Patients With Lupus

NCT00483613

Sponsor

University Hospital Virgen de las Nieves

Status

Completed

Last Update Posted

Jun 7, 2007Estimated

Enrollment

45Actual

Phase

Not Applicable

Conditions

Systemic Lupus Erythematosus

Interventions

Cognitive-behavioral therapy of Meichenbaum

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2003

Primary Completion Date

Not provided

Completion Date

Jul 2005Actual

First Submitted Date

Jun 6, 2007

First Submission Date that Met QC Criteria

Jun 6, 2007

First Posted Date

Jun 7, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 6, 2007

Last Update Posted Date

Jun 7, 2007Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

University Hospital Virgen de las NievesOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

45Actual

Name	Type	Description	Arm Group Labels	Other Names
Cognitive-behavioral therapy of Meichenbaum	Behavioral

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Activity of the disease, quality of life		Initial, 3rd. month, 9th month, 15 th month

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jiménez Juan, PhD, MD		Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Virgen de las Nieves		Granada	Spain/Granada	18012	Spain

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
15385708	Background	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.
17211991	Result

ID	Term
D003240	Connective Tissue Diseases
D017437	Skin and Connective Tissue Diseases
D001327	Autoimmune Diseases
D007154	Immune System Diseases