NCT01840709

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2010

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

October 31, 2012

Completed
6 months until next milestone

First Posted

Study publicly available on registry

April 26, 2013

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

January 9, 2014

Status Verified

January 1, 2014

Enrollment Period

3.5 years

First QC Date

October 31, 2012

Last Update Submit

January 8, 2014

Conditions

Systemic Lupus Erythematosus

Keywords

Systemic lupus erythematosusPsychotherapy

Outcome Measures

Primary Outcomes (1)

  • Quality of life

    Significant improvement of scores of SLEQOL questionnaire

    20 weeks

Secondary Outcomes (1)

  • Coping

    20 weeks

Other Outcomes (1)

  • anxiety and depression

    20 weeks

Study Arms (2)

Psychotherapy treatment

EXPERIMENTAL

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

Behavioral: Psychotherapy

control group

NO INTERVENTION

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

Interventions

PsychotherapyBEHAVIORAL

Psychoanalytic brief group psychotherapy once a week for 20 consecutive weeks

Psychotherapy treatment

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female patients,
  • SLE (ACR criteria)
  • over 18 years old
  • followed up at the clinic for at least 6 months

You may not qualify if:

  • illiterate patients,
  • patients with mental or physical comorbidities that compromise their participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidade Federal de São Paulo

São Paulo, São Paulo, 04023900, Brazil

Location

Related Publications (1)

  • 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.

    PMID: 30670099DERIVED

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Interventions

Psychotherapy

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Behavioral Disciplines and Activities

Study Officials

  • Emilia I Sato, MD, PhD

    Universidade Federal de São Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD - Professor

Study Record Dates

First Submitted

October 31, 2012

First Posted

April 26, 2013

Study Start

August 1, 2010

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

January 9, 2014

Record last verified: 2014-01

Locations

BR(1)