Lupus Erythematosus, SystemicLUPPNCT03103243
Pilot Study to Investigate Contemplative Intervention in Lupus Patients
A study testing Mindfulness Based Group Sessions in people with Lupus Erythematosus, Systemic, run by University of Virginia at 1 site in United States.
Trial summary
The study tests whether contemplative-based intervention can modify pathogenic processes in participants with Lupus. Techniques such as meditation, mindfulness and yoga may have an impact on the disease and may decrease psychological distress, increase self-regulation capabilities, and reduce pain. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lupus Erythematosus, Systemic
- What is being tested?
- Mindfulness Based Group Sessions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Apr 2017to 4 Jun 2018
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males and females who have given written informed consent
- 18 and older
- Literate in English: able to read, understand, follow instructions, and complete the rating scales and questionnaires accurately
- Have a clinical diagnosis of systemic lupus erythematosus
- Must pass the initial MRI screening administered over the phone
- Inclusion criteria for support person: must be able to attend sessions with SLE patient.
Who cannot join
- Significant previous mindfulness training and experience (e.g. MBSR course, daily meditation practice)
- Any current Axis I DSM-IV-TR psychiatric disorder that, in the clinician's opinion, warrants treatment or would preclude safe participation in the protocol, including, but not limited to: psychosis, schizophrenia, dementia, schizotypal personality disorder, borderline personality disorder, bipolar disorder, primary diagnosis of eating disorder, or chronic suicidality or homicidality.
- Have clinical evidence of significant unstable or uncontrolled acute or chronic diseases not related to SLE (i.e., diabetes, cardiovascular, pulmonary, hematologic, gastrointestinal, neurological, or infectious) which, in the opinion of the treating physician, could confound the results of the study or put the patients at undue risk
- Chronic use of prescribed or recreational psychoactive drugs (self-reported)
- Have current drug or alcohol abuse or dependence, or a history of drug or alcohol abuse or dependence within 364 days prior to Baseline (self-reported)
- Diagnosis of lupus for over 20 years
- Too sick to meaningfully participate (e.g. hospitalized, flaring at the time of screening)
- In order to participate in the MRI portion of the study, participants must pass the in-person MRI screening administered by the MRI technician before each MRI. If participants fail the in-person MRI screening, they will be excluded from the MRI portion of the study, but can still participate in the intervention and blood draw portions of the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia
Charlottesville, Virginia, 22903
About this study
Official title: A Pilot Study to Investigate a Contemplation-Based Intervention and Health Outcomes in Systemic Lupus Erythematosus Patients
The study tests whether contemplative-based intervention can modify pathogenic processes in participants with Lupus. Techniques such as meditation, mindfulness and yoga may have an impact on the disease and may decrease psychological distress, increase self-regulation capabilities, and reduce pain. Additionally, incorporating patients' caregivers may strengthen their relationships and, thereby, improve their health and well-being.
Read the detailed description
The objective of this pilot study is to test the feasibility of an innovative contemplative-based and caregiver-inclusive intervention can modify pathogenic processes in systemic lupus erythematosus (SLE). Contemplative techniques such as meditation, mindfulness and yoga may have an impact on the disease burden and may decrease psychological distress, increase self-regulation capabilities, and reduce pain. Research also suggests that contemplative practices, such as an intensive mindfulness intervention, may have a direct effect on the underlying disease process itself by altering epigenetic control of gene expression, decreasing proinflammatory cytokine production and reestablishing immunologic homeostasis. It is also well documented that social relationships moderate physical health. Incorporating patients' caregivers may strengthen their relationships and thereby improve their health and well-being. It is anticipated that the successful outcome of the intervention described in this proposal will provide the basis for a new and effective contemplative-based and caregiver-inclusive therapy for SLE and other rheumatic diseases.
- Conditions
- Lupus Erythematosus, Systemic
- Being tested
- Mindfulness Based Group Sessions
- Keywords
- Lupus, SLE, Erythematosus
- 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.
Mindfulness Based Group SessionsBehavioural
In-person group intervention sessions conducted with a combination of meditation, group exercise (yoga), group discussions, deep breathing and other mindfulness based practices.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Other | This is a single arm trial. All participants will be administered two baseline fMRIs and blood analysis prior to participation in a mindfulness group and individual mindfulness intervention sessions. A post intervention fMRI and blood analysis will complete the trial participation. Receives: Behavioral: Mindfulness Based Group Sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in blood
Number of participants with abnormal lab values (Complete Blood Count, Chemistry Panel, Autoantibodies, Complement C3 \& C4, Cytokines)
Measured: Baseline Assessment, within 2 weeks prior to intervention, within 2 weeks after intervention
Secondary outcomes (5)
Change from baseline in brain activity during functional MRI
Number of participants with change in brain activity during functional MRI tasks (Handholding, Balloon Analog Risk Task, Penn Emotion Recognition Task, Operation Span Task, Resting State Task)
Measured: Baseline Assessment, within 2 weeks prior to intervention, within 2 weeks after intervention
Change from baseline in Patient Reported Outcomes
Patient-reported change in health and symptoms
Measured: Baseline Assessment, within 2 weeks prior to intervention, throughout the 6-week intervention, within 2 weeks after intervention
Change from baseline in SLE disease activity
Systemic Lupus Activity Questionnaire (SLAQ)
Measured: Baseline Assessment, within 2 weeks prior to intervention, within 2 weeks after intervention
Change from baseline in psychosocial function
Self reported psychosocial function
Measured: Baseline Assessment, within 2 weeks prior to intervention, throughout the 6-week intervention, within 2 weeks after intervention
Change from baseline in Heart Rate Variability
Collected using emWave device
Measured: Throughout the entire 6-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2017
- Study start27 Apr 2017
- Primary completion4 Jun 2018
- Study completion4 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lupus Erythematosus, SystemicStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Collaborators
- Lupus Research Alliance
- Responsible party
- Sponsor
- Investigators
- James A Coan, Ph.D., Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03103243
- Sponsor's protocol ID
- 19671
- Acronym
- LUPP
- Status last verified
- Mar 2019
- First submitted
- 22 Mar 2017
- Last updated
- 14 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Investigate a Contemplation-Based Intervention and Health Outcomes in Systemic Lupus Erythematosus Patients
- ClinicalTrials.gov ID
- NCT03103243
- Acronym / sponsor ID
- LUPP / 19671
- Conditions
- Lupus Erythematosus, Systemic
- Keywords
- Lupus, SLE, Erythematosus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- Lupus Research Alliance
- Study start
- 27 Apr 2017 (actual)
- Primary completion
- 4 Jun 2018 (actual)
- Study completion
- 4 Jun 2018 (actual)
- First posted
- 6 Apr 2017 (actual)
- 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.
The study tests whether contemplative-based intervention can modify pathogenic processes in participants with Lupus. Techniques such as meditation, mindfulness and yoga may have an impact on the disease and may decrease psychological distress, increase self-regulation capabilities, and reduce pain. Additionally, incorporating patients' caregivers may strengthen their relationships and, thereby, improve their health and well-being.
Detailed description
The objective of this pilot study is to test the feasibility of an innovative contemplative-based and caregiver-inclusive intervention can modify pathogenic processes in systemic lupus erythematosus (SLE). Contemplative techniques such as meditation, mindfulness and yoga may have an impact on the disease burden and may decrease psychological distress, increase self-regulation capabilities, and reduce pain. Research also suggests that contemplative practices, such as an intensive mindfulness intervention, may have a direct effect on the underlying disease process itself by altering epigenetic control of gene expression, decreasing proinflammatory cytokine production and reestablishing immunologic homeostasis. It is also well documented that social relationships moderate physical health. Incorporating patients' caregivers may strengthen their relationships and thereby improve their health and well-being. It is anticipated that the successful outcome of the intervention described in this proposal will provide the basis for a new and effective contemplative-based and caregiver-inclusive therapy for SLE and other rheumatic diseases.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Other | Behavioral: Mindfulness Based Group SessionsThis is a single arm trial. All participants will be administered two baseline fMRIs and blood analysis prior to participation in a mindfulness group and individual mindfulness intervention sessions. A post intervention fMRI and blood analysis will complete the trial participation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Males and females who have given written informed consent
- 18 and older
- Literate in English: able to read, understand, follow instructions, and complete the rating scales and questionnaires accurately
- Have a clinical diagnosis of systemic lupus erythematosus
- Must pass the initial MRI screening administered over the phone
Key exclusion criteria (8 listed)
- Significant previous mindfulness training and experience (e.g. MBSR course, daily meditation practice)
- Any current Axis I DSM-IV-TR psychiatric disorder that, in the clinician's opinion, warrants treatment or would preclude safe participation in the protocol, including, but not limited to: psychosis, schizophrenia, dementia, schizotypal personality disorder, borderline personality disorder, bipolar disorder, primary diagnosis of eating disorder, or chronic suicidality or homicidality.
- Have clinical evidence of significant unstable or uncontrolled acute or chronic diseases not related to SLE (i.e., diabetes, cardiovascular, pulmonary, hematologic, gastrointestinal, neurological, or infectious) which, in the opinion of the treating physician, could confound the results of the study or put the patients at undue risk
- Chronic use of prescribed or recreational psychoactive drugs (self-reported)
- Have current drug or alcohol abuse or dependence, or a history of drug or alcohol abuse or dependence within 364 days prior to Baseline (self-reported)
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 |
|---|---|---|
| Mindfulness Based Group SessionsIn-person group intervention sessions conducted with a combination of meditation, group exercise (yoga), group discussions, deep breathing and other mindfulness based practices. | Behavioural | Intervention |
Primary outcome
Change from baseline in blood
Time frame: Baseline Assessment, within 2 weeks prior to intervention, within 2 weeks after intervention
Number of participants with abnormal lab values (Complete Blood Count, Chemistry Panel, Autoantibodies, Complement C3 \& C4, Cytokines)
5 secondary outcomes
Change from baseline in brain activity during functional MRI
Time frame: Baseline Assessment, within 2 weeks prior to intervention, within 2 weeks after intervention
Change from baseline in Patient Reported Outcomes
Time frame: Baseline Assessment, within 2 weeks prior to intervention, throughout the 6-week intervention, within 2 weeks after intervention
Change from baseline in SLE disease activity
Time frame: Baseline Assessment, within 2 weeks prior to intervention, within 2 weeks after intervention
Change from baseline in psychosocial function
Time frame: Baseline Assessment, within 2 weeks prior to intervention, throughout the 6-week intervention, within 2 weeks after intervention
Change from baseline in Heart Rate Variability
Time frame: Throughout the entire 6-week intervention
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 14 Mar 2019.
- Individual participant dataSharing planned: No
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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.
James A Coan, Ph.D. principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness Based Group Sessions in people with Lupus Erythematosus, Systemic, run by University of Virginia at 1 site in United States.
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 6 inclusion and 8 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 14 Mar 2019. 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 United States. 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?
Change from baseline in blood (time frame: Baseline Assessment, within 2 weeks prior to intervention, within 2 weeks after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Mar 2019; AzTrials last refreshed its copy on 3 Nov 2026.