Effectiveness Study of Psychotherapy in Systemic Lupus Erythematosus (PSYCHO)

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

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.

Study Overview

• Status: Unknown
• Conditions: Systemic Lupus Erythematosus
• Intervention / Treatment: Behavioral: Psychotherapy

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
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • São Paulo, Brazil, 04023900
    • Universidade Federal de Sao Paulo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life	Significant improvement of scores of SLEQOL questionnaire	20 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Coping	Coping were assessed by Coping strategies inventory of Folkman and Lazarus.	20 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
anxiety and depression	these variables will be assessed by Hospital Anxiety and Depression Scale	20 weeks

Collaborators and Investigators

• Sponsor: Federal University of São Paulo
• Investigators: Principal Investigator: Emilia I Sato, MD, PhD, Universidade Federal de Sao Paulo

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (Anticipated): February 1, 2014
• Study Completion (Anticipated): February 1, 2014

Study Registration Dates

• First Submitted: October 31, 2012
• First Submitted That Met QC Criteria: April 25, 2013
• First Posted (Estimate): April 26, 2013

Study Record Updates

• Last Update Posted (Estimate): January 9, 2014
• Last Update Submitted That Met QC Criteria: January 8, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Keywords: Systemic lupus erythematosus; Psychotherapy
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Connective Tissue Diseases; Lupus Erythematosus, Systemic
• Other Study ID Numbers: UNIFESP.PSYCHO