Effectiveness Study of Psychotherapy in Systemic Lupus Erythematosus (PSYCHO)
Primary Purpose
Systemic Lupus Erythematosus
Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Psychotherapy
Sponsored by
About this trial
This is an interventional health services research trial for Systemic Lupus Erythematosus focused on measuring Systemic lupus erythematosus, Psychotherapy
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
Sites / Locations
- Universidade Federal de São Paulo
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Psychotherapy treatment
control group
Arm Description
The experimental group will be treated with Psychoanalytic brief group psychotherapy once a week for 20 consecutive weeks.
the patients in this group will be just assessed with the same questionnaires at baseline and after 20 weeks, without psychotherapy.
Outcomes
Primary Outcome Measures
Quality of life
Significant improvement of scores of SLEQOL questionnaire
Secondary Outcome Measures
Coping
Coping were assessed by Coping strategies inventory of Folkman and Lazarus.
Full Information
NCT ID
NCT01840709
First Posted
October 31, 2012
Last Updated
January 8, 2014
Sponsor
Federal University of São Paulo
1. Study Identification
Unique Protocol Identification Number
NCT01840709
Brief Title
Effectiveness Study of Psychotherapy in Systemic Lupus Erythematosus
Acronym
PSYCHO
Official Title
Effectiveness Study of Brief Group Psychoanalytic Psychotherapy (BGPP) to Improve Quality of Life in Patients With Systemic Lupus Erythematosus.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Unknown status
Study Start Date
August 2010 (undefined)
Primary Completion Date
February 2014 (Anticipated)
Study Completion Date
February 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of São Paulo
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Lupus Erythematosus
Keywords
Systemic lupus erythematosus, Psychotherapy
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Psychotherapy treatment
Arm Type
Experimental
Arm Description
The experimental group will be treated with Psychoanalytic brief group psychotherapy once a week for 20 consecutive weeks.
Arm Title
control group
Arm Type
No Intervention
Arm Description
the patients in this group will be just assessed with the same questionnaires at baseline and after 20 weeks, without psychotherapy.
Intervention Type
Behavioral
Intervention Name(s)
Psychotherapy
Intervention Description
Psychoanalytic brief group psychotherapy once a week for 20 consecutive weeks
Primary Outcome Measure Information:
Title
Quality of life
Description
Significant improvement of scores of SLEQOL questionnaire
Time Frame
20 weeks
Secondary Outcome Measure Information:
Title
Coping
Description
Coping were assessed by Coping strategies inventory of Folkman and Lazarus.
Time Frame
20 weeks
Other Pre-specified Outcome Measures:
Title
anxiety and depression
Description
these variables will be assessed by Hospital Anxiety and Depression Scale
Time Frame
20 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emilia I Sato, MD, PhD
Organizational Affiliation
Universidade Federal de São Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidade Federal de São Paulo
City
São Paulo
ZIP/Postal Code
04023900
Country
Brazil
12. IPD Sharing Statement
Citations:
PubMed Identifier
30670099
Citation
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.
Results Reference
derived
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Effectiveness Study of Psychotherapy in Systemic Lupus Erythematosus
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