Pilot Study to Investigate Contemplative Intervention in Lupus Patients

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.

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.