The efficacy of cognitive- behavioral stress management group therapy on chronic stress, depression and quality of life of female patients with systemic lupus erythematosus
The purpose of this study was to determine the efficacy of cognitive- behavioral stress management group therapy on chronic stress, depression and quality of life of female patients with systemic lupus erythematosus. A total of 24 female patients with SLE who received this diagnosis, according the ACR criteria, were randomly selected and assigned into experimental or control group. The experimental group received 10 weekly sessions in the clinic of rheumatology in Alzahra Hospital. The Cohen Perceived Stress Scale, Quality of Life Questionnaire (WHOQOL-BREF) and Beck Depression Inventory (BDI) were used as the pretest, post-pest and follow-up. The follow-up measurements were conducted two months after the end of intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201010114909N1
Registration date:2011-01-01, 1389/10/11
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-01-01, 1389/10/11
Registrant information
Name
Fateme Neissiani Habib Abadi
Name of organization / entity
Isfahan University
Country
Iran (Islamic Republic of)
Phone
+98 31 1433 3761
Email address
f.neissiani@edu.ui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University
Expected recruitment start date
2009-10-23, 1388/08/01
Expected recruitment end date
2010-03-19, 1388/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The efficacy of cognitive- behavioral stress management group therapy on chronic stress, depression and quality of life of female patients with systemic lupus erythematosus
Public title
Effectiveness of cognitive- behavioral therapy on SLE
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: being female, age 18-55 years, having at least diploma degree
Exclusion criteria: treatment for a psychiatric pathology
Age
From 18 years old to 55 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
24
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahan University
Street address
Hezar garib st, Azadi sq, Isfahan
City
Isfahan
Postal code
8174673441
Approval date
2010-03-15, 1388/12/24
Ethics committee reference number
89/6427
Health conditions studied
1
Description of health condition studied
Systemic lupus erythematesus
ICD-10 code
M32
ICD-10 code description
Primary outcomes
1
Description
chronic stress
Timepoint
before intervention- 2 months after intervention- 4 months after intervention
Method of measurement
The Cohen Perceived Stress Scale
Secondary outcomes
1
Description
depression
Timepoint
before intervention- 2 months after intervention- 4 months after intervention
Method of measurement
Beck Depression Inventory (BDI)
2
Description
quality of life
Timepoint
before intervention- 2 months after intervention- 4 months after intervention
Method of measurement
Quality of Life Questionnaire (WHOQOL-BREF)
Intervention groups
1
Description
Control group: No intervention.
Category
N/A
2
Description
Intervention group: cognitive- behavioral stress management group therapy. The therapy consisted of ten consecutive weekly sessions and each sessions lasted 90 minutes.