Pilot Study to Investigate Contemplative Intervention in Lupus Patients

Completed · Not applicable

Conditions studied: Lupus Erythematosus, Systemic

In brief

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.

Key facts

Study ID

NCT03103243

Run by

University of Virginia

People needed

30

Starts

2017-04-27

Expected to finish

2018-06-04

Last updated by the study team

2019-03-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Virginia — Charlottesville, Virginia, United States

Full record on ClinicalTrials.gov

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