Pilot Study to Investigate Contemplative Intervention in Lupus Patients

NCT03103243 | Completed

• 1 other identifier: 19671
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Lupus Erythematosus, Systemic

Keywords

Lupus; SLE; Erythematosus

Outcome Measures

Primary Outcomes (1)

• Change from baseline in blood

  Number of participants with abnormal lab values (Complete Blood Count, Chemistry Panel, Autoantibodies, Complement C3 \& C4, Cytokines)

  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

  Baseline Assessment, within 2 weeks prior to intervention, within 2 weeks after intervention

• Change from baseline in Patient Reported Outcomes

  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

  Baseline Assessment, within 2 weeks prior to intervention, within 2 weeks after intervention

• Change from baseline in psychosocial function

  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

  Throughout the entire 6-week intervention

Study Arms (1)

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.

Behavioral: Mindfulness Based Group Sessions

Interventions

Mindfulness Based Group Sessions BEHAVIORAL

In-person group intervention sessions conducted with a combination of meditation, group exercise (yoga), group discussions, deep breathing and other mindfulness based practices.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females who have given written informed consent
• 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

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.

Sponsors & Collaborators

• University of Virginia: lead
• Lupus Research Alliance: collaborator

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22903, United States

Location

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• James A Coan, Ph.D.

  University of Virginia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2017
• First Posted: April 6, 2017
• Study Start: April 27, 2017
• Primary Completion: June 4, 2018
• Study Completion: June 4, 2018
• Last Updated: March 14, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)