This trial is active, not recruiting.

Condition systemic lupus erythematosus
Treatment psychotherapy
Sponsor Federal University of São Paulo
Start date August 2010
End date February 2014
Trial size 80 participants
Trial identifier NCT01840709, UNIFESP.PSYCHO


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose health services research
The experimental group will be treated with Psychoanalytic brief group psychotherapy once a week for 20 consecutive weeks.
Psychoanalytic brief group psychotherapy once a week for 20 consecutive weeks
(No Intervention)
the patients in this group will be just assessed with the same questionnaires at baseline and after 20 weeks, without psychotherapy.

Primary Outcomes

Quality of life
time frame: 20 weeks

Secondary Outcomes

time frame: 20 weeks

Eligibility Criteria

Female participants at least 18 years old.

Inclusion Criteria: - Female patients, - SLE (ACR criteria) - over 18 years old - followed up at the clinic for at least 6 months Exclusion Criteria: - illiterate patients, - patients with mental or physical comorbidities that compromise their participation

Additional Information

Official title Effectiveness Study of Brief Group Psychoanalytic Psychotherapy (BGPP) to Improve Quality of Life in Patients With Systemic Lupus Erythematosus.
Principal investigator Emilia I Sato, MD, PhD
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 Bombardier,1992); - Systemic Symptom Checklist (SSC)(Freire, 2008); - Systemic Lupus Erythematosus Quality of Life - SLEQOL (Freire, 2008); - Coping strategies inventory of Folkman and Lazarus (Savoia,1996). - 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 Student's t test, Mann-Whitney, Wilcoxon or ANOVA for quantitative variables. P values <0.05 will be considered as significant.
Trial information was received from ClinicalTrials.gov and was last updated in January 2014.
Information provided to ClinicalTrials.gov by Federal University of São Paulo.