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Trial record 59 of 703 for:    lupus AND Lupus Erythematosus, Systemic

Effectiveness Study of Psychotherapy in Systemic Lupus Erythematosus (PSYCHO)

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ClinicalTrials.gov Identifier: NCT01840709
Recruitment Status : Unknown
Verified January 2014 by Emilia Inoue Sato, Federal University of São Paulo.
Recruitment status was:  Active, not recruiting
First Posted : April 26, 2013
Last Update Posted : January 9, 2014
Sponsor:
Information provided by (Responsible Party):
Emilia Inoue Sato, Federal University of São Paulo

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.


Condition or disease Intervention/treatment Phase
Systemic Lupus Erythematosus Behavioral: Psychotherapy Not Applicable

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 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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Effectiveness Study of Brief Group Psychoanalytic Psychotherapy (BGPP) to Improve Quality of Life in Patients With Systemic Lupus Erythematosus.
Study Start Date : August 2010
Estimated Primary Completion Date : February 2014
Estimated Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus

Arm Intervention/treatment
Experimental: Psychotherapy treatment
The experimental group will be treated with Psychoanalytic brief group psychotherapy once a week for 20 consecutive weeks.
Behavioral: Psychotherapy
Psychoanalytic brief group psychotherapy once a week for 20 consecutive weeks

No Intervention: control group
the patients in this group will be just assessed with the same questionnaires at baseline and after 20 weeks, without psychotherapy.



Primary Outcome Measures :
  1. Quality of life [ Time Frame: 20 weeks ]
    Significant improvement of scores of SLEQOL questionnaire


Secondary Outcome Measures :
  1. Coping [ Time Frame: 20 weeks ]
    Coping were assessed by Coping strategies inventory of Folkman and Lazarus.


Other Outcome Measures:
  1. anxiety and depression [ Time Frame: 20 weeks ]
    these variables will be assessed by Hospital Anxiety and Depression Scale



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01840709


Locations
Brazil
Universidade Federal de São Paulo
São Paulo, Brazil, 04023900
Sponsors and Collaborators
Federal University of São Paulo
Investigators
Principal Investigator: Emilia I Sato, MD, PhD Universidade Federal de São Paulo

Responsible Party: Emilia Inoue Sato, MD, PhD - Professor, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT01840709     History of Changes
Other Study ID Numbers: UNIFESP.PSYCHO
First Posted: April 26, 2013    Key Record Dates
Last Update Posted: January 9, 2014
Last Verified: January 2014

Keywords provided by Emilia Inoue Sato, Federal University of São Paulo:
Systemic lupus erythematosus
Psychotherapy

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases