Clinical trial NCT03103243: Pilot Study to Investigate Contemplative Intervention in Lupus Patients
Official title: A Pilot Study to Investigate a Contemplation-Based Intervention and Health Outcomes in Systemic Lupus Erythematosus Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lupus Erythematosus, Systemic
Keywords: Lupus
SLE
Erythematosus
Lead sponsor: University of Virginia
Sponsor class: OTHER
Collaborators: name: Lupus Research Alliance
First posted: 2017-04-06
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change from baseline in blood
timeFrame: Baseline Assessment, within 2 weeks prior to intervention, within 2 weeks after intervention
Secondary outcomes:
measure: Change from baseline in brain activity during functional MRI
timeFrame: Baseline Assessment, within 2 weeks prior to intervention, within 2 weeks after intervention
measure: Change from baseline in Patient Reported Outcomes
timeFrame: Baseline Assessment, within 2 weeks prior to intervention, throughout the 6-week intervention, within 2 weeks after intervention
measure: Change from baseline in SLE disease activity
timeFrame: Baseline Assessment, within 2 weeks prior to intervention, within 2 weeks after intervention
measure: Change from baseline in psychosocial function
timeFrame: Baseline Assessment, within 2 weeks prior to intervention, throughout the 6-week intervention, within 2 weeks after intervention
measure: Change from baseline in Heart Rate Variability
timeFrame: Throughout the entire 6-week intervention
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
affiliation: University of Virginia
name: James A Coan, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: