Effects of Treatment of Chronic Stress in Patients With Lupus

NCT00483613 | Completed DMC

• 1 other identifier: 1-Alonso
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Systemic Lupus Erythematosus

Keywords

Daily stress; Cognitive-behavioral therapy; Quality of life; SLEDAI

Outcome Measures

Primary Outcomes (1)

• Activity of the disease, quality of life

  Initial, 3rd. month, 9th month, 15 th month

Secondary Outcomes (1)

• 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

Interventions

Cognitive-behavioral therapy of Meichenbaum BEHAVIORAL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Virgen de las Nieves: lead

Study Sites (1)

University Hospital Virgen de las Nieves

Granada, Spain/Granada, 18012, Spain

Location

Related Publications (2)

• 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.

  PMID: 15385708 BACKGROUND

• 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.

  PMID: 17211991 RESULT

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Jiménez Juan, PhD, MD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 6, 2007
• First Posted: June 7, 2007
• Study Start: December 1, 2003
• Study Completion: July 1, 2005
• Last Updated: June 7, 2007

Record last verified: 2007-06

Locations

ES (1)