Effectiveness Study of Psychotherapy in Systemic Lupus Erythematosus

NCT ID: NCT01840709

Last Updated: 2014-01-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-08-31
• Study Completion Date: 2014-02-28

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.

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.

Conditions

Systemic Lupus Erythematosus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Psychotherapy treatment

The experimental group will be treated with Psychoanalytic brief group psychotherapy once a week for 20 consecutive weeks.

Group Type: EXPERIMENTAL

Psychotherapy

Intervention Type: BEHAVIORAL

Psychoanalytic brief group psychotherapy once a week for 20 consecutive weeks

control group

the patients in this group will be just assessed with the same questionnaires at baseline and after 20 weeks, without psychotherapy.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Psychotherapy

Psychoanalytic brief group psychotherapy once a week for 20 consecutive weeks

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Federal University of São Paulo

OTHER

Sponsor Role: lead

Responsible Party

Emilia Inoue Sato

MD, PhD - Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Emilia I Sato, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidade Federal de São Paulo

Locations

Universidade Federal de São Paulo

São Paulo, São Paulo, Brazil

Countries

Brazil

References

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.

Reference Type: DERIVED

PMID: 30670099 (View on PubMed)

Other Identifiers

UNIFESP.PSYCHO

Identifier Type: -

Identifier Source: org_study_id