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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.
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:
Exclusion criteria :
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Psychotherapy treatment | Experimental | The experimental group will be treated with Psychoanalytic brief group psychotherapy once a week for 20 consecutive weeks. |
|
| control group | No Intervention | the patients in this group will be just assessed with the same questionnaires at baseline and after 20 weeks, without psychotherapy. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Psychotherapy | Behavioral | Psychoanalytic brief group psychotherapy once a week for 20 consecutive weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life | Significant improvement of scores of SLEQOL questionnaire | 20 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Coping | Coping were assessed by Coping strategies inventory of Folkman and Lazarus. | 20 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| anxiety and depression | these variables will be assessed by Hospital Anxiety and Depression Scale | 20 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Emilia I Sato, MD, PhD | Universidade Federal de São Paulo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidade Federal de São Paulo | São Paulo | São Paulo | 04023900 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30670099 | Derived | Conceicao CTM, Meinao IM, Bombana JA, Sato EI. Psychoanalytic psychotherapy improves quality of life, depression, anxiety and coping in patients with systemic lupus erythematosus: a controlled randomized clinical trial. Adv Rheumatol. 2019 Jan 22;59(1):4. doi: 10.1186/s42358-019-0047-y. |
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| ID | Term |
|---|---|
| D008180 | Lupus Erythematosus, Systemic |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D011613 | Psychotherapy |
| ID | Term |
|---|---|
| D004191 | Behavioral Disciplines and Activities |
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