Systemic Lupus ErythematosusPSYCHONCT01840709
Effectiveness Study of Psychotherapy in Systemic Lupus Erythematosus
A study testing Psychotherapy in people with Systemic Lupus Erythematosus, run by Federal University of São Paulo at 1 site in Brazil.
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Systemic Lupus Erythematosus
- What is being tested?
- Psychotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2010to Feb 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients,
- SLE (ACR criteria)
- over 18 years old
- followed up at the clinic for at least 6 months
Who cannot join
- illiterate patients,
- patients with mental or physical comorbidities that compromise their participation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- Psychotherapy
- Keywords
- Systemic lupus erythematosus, Psychotherapy
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsychotherapyBehavioural
Psychoanalytic brief group psychotherapy once a week for 20 consecutive weeks
| Study group | Role | What they receive |
|---|---|---|
| Psychotherapy treatment | Experimental | The experimental group will be treated with Psychoanalytic brief group psychotherapy once a week for 20 consecutive weeks. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life
Significant improvement of scores of SLEQOL questionnaire
Measured: 20 weeks
Secondary outcomes (1)
Coping
Coping were assessed by Coping strategies inventory of Folkman and Lazarus.
Measured: 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2013 (estimated)
- Study startAug 2010
- Primary completionFeb 2014 (estimated)
- Study completionFeb 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emilia Inoue Sato, Federal University of São Paulo
- Investigators
- Emilia I Sato, MD, PhD, Principal investigator, Universidade Federal de São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01840709
- Sponsor's protocol ID
- UNIFESP.PSYCHO
- Acronym
- PSYCHO
- Status last verified
- Jan 2014
- First submitted
- 31 Oct 2012
- Last updated
- 9 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 30670099
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness Study of Brief Group Psychoanalytic Psychotherapy (BGPP) to Improve Quality of Life in Patients With Systemic Lupus Erythematosus.
- ClinicalTrials.gov ID
- NCT01840709
- Acronym / sponsor ID
- PSYCHO / UNIFESP.PSYCHO
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- Systemic lupus erythematosus, Psychotherapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Feb 2014 (estimated)
- Study completion
- Feb 2014 (estimated)
- First posted
- 26 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Psychotherapy treatment | Experimental | Behavioral: PsychotherapyThe experimental group will be treated with Psychoanalytic brief group psychotherapy once a week for 20 consecutive weeks. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Female patients,
- SLE (ACR criteria)
- over 18 years old
- followed up at the clinic for at least 6 months
Key exclusion criteria (2 listed)
- illiterate patients,
- patients with mental or physical comorbidities that compromise their participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PsychotherapyPsychoanalytic brief group psychotherapy once a week for 20 consecutive weeks | Behavioural | Psychotherapy treatment |
Primary outcome
Quality of life
Time frame: 20 weeks
Significant improvement of scores of SLEQOL questionnaire
1 secondary outcome
Coping
Time frame: 20 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2014.
- Derived from this study: PubMed 30670099Conceicao 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emilia I Sato, MD, PhD principal investigator
Universidade Federal de São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychotherapy in people with Systemic Lupus Erythematosus, run by Federal University of São Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life (time frame: 20 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01840709, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2014.