Effectiveness Study of Psychotherapy in Systemic Lupus Erythematosus

Systemic Lupus Erythematosus Clinical Trial

— PSYCHO  

Official title:

Effectiveness Study of Brief Group Psychoanalytic Psychotherapy (BGPP) to Improve Quality of Life in Patients With Systemic Lupus Erythematosus.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01840709
• Other study ID #: UNIFESP.PSYCHO
• Status: Active, not recruiting
• Phase: N/A
• First received: October 31, 2012
• Last updated: January 8, 2014
• Start date: August 2010
• Est. completion date: February 2014

Study information

• Verified date: January 2014
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Intervention

Behavioral:
• Psychotherapy
Psychoanalytic brief group psychotherapy once a week for 20 consecutive weeks

Locations

Country	Name	City	State
Brazil	Universidade Federal de São Paulo	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	anxiety and depression	these variables will be assessed by Hospital Anxiety and Depression Scale	20 weeks	No
Primary	Quality of life	Significant improvement of scores of SLEQOL questionnaire	20 weeks	No
Secondary	Coping	Coping were assessed by Coping strategies inventory of Folkman and Lazarus.	20 weeks	No