Ignite Creation Date:
2024-05-06 @ 1:35 AM
Last Modification Date:
2024-10-26 @ 11:06 AM
Study NCT ID:
NCT01840709
Status:
UNKNOWN
Last Update Posted:
2014-01-09
First Post:
2012-10-31
Brief Title:
Effectiveness Study of Psychotherapy in Systemic Lupus Erythematosus
Sponsor:
Federal University of São Paulo
Organization:
Federal University of São Paulo
Study Overview
Official Title:
Effectiveness Study of Brief Group Psychoanalytic Psychotherapy BGPP to Improve Quality of Life in Patients With Systemic Lupus Erythematosus
Status:
UNKNOWN
Status Verified Date:
2014-01
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
PSYCHO
Brief Summary:
Psychosomatic is a new approach to understanding the phenomena of somatization using the knowledge of medicine and psychology to treat human being A Brief Group Psychanalytic Psychotherapy BGPP for psychosomatic patients has been used to supplement the treatment of some diseases including Systemic Lupus Erythematosus SLE The hypothesis of the study is that BGPP beside clinical treatment can improve the quality of life and coping in SLE patients The aim of the study is to evaluate the effectiveness of BGPP in Brazilian SLE patients
Primary objective To evaluate the effectiveness of BGPP to improve quality of life Secondary objectives To evaluate the effectiveness of BGPP to improve coping anxiety and depression symptoms SLE patients will be randomized to receive Psychotherapy or only clinical treatment The effectiveness will be assessed through specific questionnaires
Primary objective To evaluate the effectiveness of BGPP to improve quality of life Secondary objectives To evaluate the effectiveness of BGPP to improve coping anxiety and depression symptoms SLE patients will be randomized to receive Psychotherapy or only clinical treatment The effectiveness will be assessed through specific questionnaires
Detailed Description:
This is a prospective randomized clinical trial Patients with SLE ACR criteria 1997 treated at Rheumatology Division out-patient clinic of a university hospital were enrolled A sample of 80 patients was assessed at the beginning of the study baseline and will be re-evaluated after 20 weeks final by clinical and psychological scales Patients were randomized by computer program and divided into experimental group EG and control group CG Patients of both groups continued their medical treatment at the clinic EG will be treated with BGPP for 20 sessions once a week for 20 consecutive weeks in small groups The control group will be on a waiting list until the end of the study and will be treated subsequently
Inclusion criteria
Female gender
Four or more ACR criteria for classification of SLE
Age above 18 years
Follow-up at the clinic for at least 6 months
Exclusion criteria
Illiterate patients
Mental or physical comorbidities that compromise their participation
Evaluation
The following scales adapted and validated for Portuguese Language were being applied for a blinded evaluator to assess patients at baseline and after 20 weeks
Systemic Lupus International Disease Activity - SLEDAI Bombardier1992
Systemic Symptom Checklist SSCFreire 2008
Systemic Lupus Erythematosus Quality of Life - SLEQOL Freire 2008
Coping strategies inventory of Folkman and Lazarus Savoia1996
Hospital Anxiety and Depression Botega 1995
Vital events scale of Holmes and Rahe 1967 Savoia 1995 and
Comparisons inter and intra groups were being analyzed using the Q square test for categorical variables and Students t test Mann-Whitney Wilcoxon or ANOVA for quantitative variables P values 005 will be considered as significant
Inclusion criteria
Female gender
Four or more ACR criteria for classification of SLE
Age above 18 years
Follow-up at the clinic for at least 6 months
Exclusion criteria
Illiterate patients
Mental or physical comorbidities that compromise their participation
Evaluation
The following scales adapted and validated for Portuguese Language were being applied for a blinded evaluator to assess patients at baseline and after 20 weeks
Systemic Lupus International Disease Activity - SLEDAI Bombardier1992
Systemic Symptom Checklist SSCFreire 2008
Systemic Lupus Erythematosus Quality of Life - SLEQOL Freire 2008
Coping strategies inventory of Folkman and Lazarus Savoia1996
Hospital Anxiety and Depression Botega 1995
Vital events scale of Holmes and Rahe 1967 Savoia 1995 and
Comparisons inter and intra groups were being analyzed using the Q square test for categorical variables and Students t test Mann-Whitney Wilcoxon or ANOVA for quantitative variables P values 005 will be considered as significant
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