Systemic Lupus ErythematosusNCT00483613
Effects of Treatment of Chronic Stress in Patients With Lupus
A study testing Cognitive-behavioral therapy of Meichenbaum in people with Systemic Lupus Erythematosus, run by University Hospital Virgen de las Nieves at 1 site in Spain.
Trial summary
Daily stress can worsens the clinical course of lupus. Objective: to determine the efficacy of the stress management therapy in a group of patients with lupus. 45 patients with lupus and high daily stress participated in this clinical trial. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systemic Lupus Erythematosus
- What is being tested?
- Cognitive-behavioral therapy of Meichenbaum
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 45 participants
- Where
- 1 siteSpain
- Study dates
- Dec 2003to Jul 2005
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- SLE with at least 4 ACR criteria or patients with a diagnosis of CCL made with a biopsy
- over 18 years of age
- high levels of daily stress (defined in our population as equal to or greater than 24 points for men and 27 for women on the Cohen Perceived Stress Scale)
Who cannot join
- less than a year of diagnosis of the disease
- illiteracy
- not being available to attend the intervention sessions or to perform the established analytic determinations
- treatment for an acute psychiatric pathology
Trial locations and contacts
1 site in 1 country.
Spain1 site
University Hospital Virgen de las Nieves
Granada, Spain/Granada, 18012
About this study
- Daily stress can worsens the clinical course of lupus.
- Objective: to determine the efficacy of the stress management therapy in a group of patients with lupus.
- 45 patients with lupus and high daily stress participated in this clinical trial.
- Two groups resulted: a control group (CG) that received the usual care and a therapy group (TG) that received a cognitive behavioral therapy.
- The therapy consisted of ten consecutive weekly sessions.
- The measured variables were psychological, clinical, immunological and quality of life. At the basal moment and after 3, 9 and 15 months.
- Statistical analysis showed a significant reduction in the levels of depression, anxiety and daily stress in the therapy group, compared to the usual care group, a significant improvement in quality of life, improvements in the reported symptoms (cardiovascular, respiratory, cutaneous and musculoskeletal.
Read the detailed description
Stress, especially daily stress, worsens the lupus symptoms perceived by the patients. Our objective was to determine the efficacy of the Meichenbaum stress management therapy for dealing with high daily stress in a group of patients with lupus.
We designed a randomized clinical trial in which 45 patients with lupus and daily stress participated. The patients were randomly assigned to one of the following groups: a) a control group (CG) that received the usual care and b) a therapy group (TG) that received a cognitive behavioral type therapy, performed by a group of 3 psychologists. Both groups were similar with regard to their sociodemographic, clinical, immunological, psychological aspects at the basal moment. The therapy consisted of ten consecutive weekly sessions. Psychological and emotional, clinical, immunological variables and quality of life were evaluated at the basal moment and after 3, 9 and 15 months.
The between-groups analysis showed a significant reduction in the levels of depression, anxiety and daily stress in the TG, compared to the CG, throughout the entire follow-up period, as well as a significant improvement in quality of life. The results also showed improvements in the reported symptoms (cardiovascular, respiratory, cutaneous and musculoskeletal) in the patients from the TG, who showed significant differences with regard to their basal level and in comparison with CG patients. This study shows the efficacy of the Meichenbaum stress management therapy in patients with lupus and high daily stress, as it significantly reduces the incidence of psychological disorders related to suffering from lupus, and it significantly improves and maintains their quality of life, in spite of the absence of a significant reduction in the illness activity index.
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- Cognitive-behavioral therapy of Meichenbaum
- Keywords
- Daily stress, Cognitive-behavioral therapy, Quality of life, SLEDAI
- 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.
Cognitive-behavioral therapy of MeichenbaumBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Activity of the disease, quality of life
Measured: Initial, 3rd. month, 9th month, 15 th month
Secondary outcomes (1)
Vulnerability to stress, amount of stress, depression, anxiety, SLEDAI index activity of lupus, somatic symptoms, number of clinical flares, antiADNn antibodies and levels of seric complement C3 and C4
Measured: Initial, 3rd month, 9th month, 15th month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2007 (estimated)
- Study startDec 2003
- Study completionJul 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Virgen de las Nieves
- Sponsor type
- University, hospital or other
- Investigators
- Jiménez Juan, PhD, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00483613
- Sponsor's protocol ID
- 1-Alonso
- Status last verified
- Jun 2007
- First submitted
- 6 Jun 2007
- Last updated
- 7 Jun 2007
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Peralta-Ramirez MI, Jimenez-Alonso J, Godoy-Garcia JF, Perez-Garcia M; Group Lupus Virgen de las Nieves. The effects of daily stress and stressful life events on the clinical symptomatology of patients with lupus erythematosus. Psychosom Med. 2004 Sep-Oct;66(5):788-94. doi: 10.1097/01.psy.0000133327.41044.94.
PubMed 15385708Peralta-Ramirez MI, Coin-Mejias MA, Jimenez-Alonso J, Ortego-Centeno N, Callejas-Rubio JL, Caracuel-Romero A, Perez-Garcia M. Stress as a predictor of cognitive functioning in lupus. Lupus. 2006;15(12):858-64. doi: 10.1177/0961203306071404.
PubMed 17211991
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Treatment of Chronic Stress in Patients With Lupus
- ClinicalTrials.gov ID
- NCT00483613
- Acronym / sponsor ID
- 1-Alonso
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- Daily stress, Cognitive-behavioral therapy, Quality of life, SLEDAI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University Hospital Virgen de las NievesUniversity, hospital or other
- Study start
- Dec 2003
- Study completion
- Jul 2005 (actual)
- First posted
- 7 Jun 2007 (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.
- Daily stress can worsens the clinical course of lupus.
- Objective: to determine the efficacy of the stress management therapy in a group of patients with lupus.
- 45 patients with lupus and high daily stress participated in this clinical trial.
- Two groups resulted: a control group (CG) that received the usual care and a therapy group (TG) that received a cognitive behavioral therapy.
- The therapy consisted of ten consecutive weekly sessions.
- The measured variables were psychological, clinical, immunological and quality of life. At the basal moment and after 3, 9 and 15 months.
- Statistical analysis showed a significant reduction in the levels of depression, anxiety and daily stress in the therapy group, compared to the usual care group, a significant improvement in quality of life, improvements in the reported symptoms (cardiovascular, respiratory, cutaneous and musculoskeletal.
Detailed description
Stress, especially daily stress, worsens the lupus symptoms perceived by the patients. Our objective was to determine the efficacy of the Meichenbaum stress management therapy for dealing with high daily stress in a group of patients with lupus.
We designed a randomized clinical trial in which 45 patients with lupus and daily stress participated. The patients were randomly assigned to one of the following groups: a) a control group (CG) that received the usual care and b) a therapy group (TG) that received a cognitive behavioral type therapy, performed by a group of 3 psychologists. Both groups were similar with regard to their sociodemographic, clinical, immunological, psychological aspects at the basal moment. The therapy consisted of ten consecutive weekly sessions. Psychological and emotional, clinical, immunological variables and quality of life were evaluated at the basal moment and after 3, 9 and 15 months.
The between-groups analysis showed a significant reduction in the levels of depression, anxiety and daily stress in the TG, compared to the CG, throughout the entire follow-up period, as well as a significant improvement in quality of life. The results also showed improvements in the reported symptoms (cardiovascular, respiratory, cutaneous and musculoskeletal) in the patients from the TG, who showed significant differences with regard to their basal level and in comparison with CG patients. This study shows the efficacy of the Meichenbaum stress management therapy in patients with lupus and high daily stress, as it significantly reduces the incidence of psychological disorders related to suffering from lupus, and it significantly improves and maintains their quality of life, in spite of the absence of a significant reduction in the illness activity index.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- SLE with at least 4 ACR criteria or patients with a diagnosis of CCL made with a biopsy
- over 18 years of age
- high levels of daily stress (defined in our population as equal to or greater than 24 points for men and 27 for women on the Cohen Perceived Stress Scale)
Key exclusion criteria (4 listed)
- less than a year of diagnosis of the disease
- illiteracy
- not being available to attend the intervention sessions or to perform the established analytic determinations
- treatment for an acute psychiatric pathology
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 |
|---|---|---|
| Cognitive-behavioral therapy of Meichenbaum | Behavioural | – |
Primary outcome
Activity of the disease, quality of life
Time frame: Initial, 3rd. month, 9th month, 15 th month
1 secondary outcome
Vulnerability to stress, amount of stress, depression, anxiety, SLEDAI index activity of lupus, somatic symptoms, number of clinical flares, antiADNn antibodies and levels of seric complement C3 and C4
Time frame: Initial, 3rd month, 9th month, 15th month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2007.
- Background: PubMed 15385708Peralta-Ramirez MI, Jimenez-Alonso J, Godoy-Garcia JF, Perez-Garcia M; Group Lupus Virgen de las Nieves. The effects of daily stress and stressful life events on the clinical symptomatology of patients with lupus erythematosus. Psychosom Med. 2004 Sep-Oct;66(5):788-94. doi: 10.1097/01.psy.0000133327.41044.94.
- Results publication: PubMed 17211991Peralta-Ramirez MI, Coin-Mejias MA, Jimenez-Alonso J, Ortego-Centeno N, Callejas-Rubio JL, Caracuel-Romero A, Perez-Garcia M. Stress as a predictor of cognitive functioning in lupus. Lupus. 2006;15(12):858-64. doi: 10.1177/0961203306071404.
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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.
Jiménez Juan, PhD, MD principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive-behavioral therapy of Meichenbaum in people with Systemic Lupus Erythematosus, run by University Hospital Virgen de las Nieves at 1 site in Spain.
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 3 inclusion and 4 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: finished, as of the sponsor's last update on 7 Jun 2007. 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 Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Activity of the disease, quality of life (time frame: Initial, 3rd. month, 9th month, 15 th month). 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 NCT00483613, which also lists 2 linked publications.
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 7 Jun 2007.