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Pilot Study to Investigate Contemplative Intervention in Lupus Patients (LUPP)

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ClinicalTrials.gov Identifier: NCT03103243
Recruitment Status : Recruiting
First Posted : April 6, 2017
Last Update Posted : September 1, 2017
Sponsor:
Collaborator:
Lupus Research Alliance
Information provided by (Responsible Party):
James A. Coan, Ph.D., University of Virginia

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.

Condition or disease Intervention/treatment Phase
Lupus Erythematosus, Systemic Behavioral: Mindfulness Based Group Sessions Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study to Investigate a Contemplation-Based Intervention and Health Outcomes in Systemic Lupus Erythematosus Patients
Actual Study Start Date : April 27, 2017
Estimated Primary Completion Date : October 2017
Estimated Study Completion Date : February 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus

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




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. Change from baseline in brain activity during functional MRI [ Time Frame: Baseline Assessment, within 2 weeks prior to intervention, within 2 weeks after intervention ]
    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)

  2. 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 ]
    Patient-reported change in health and symptoms

  3. Change from baseline in SLE disease activity [ Time Frame: Baseline Assessment, within 2 weeks prior to intervention, within 2 weeks after intervention ]
    Systemic Lupus Activity Questionnaire (SLAQ)

  4. 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 ]
    Self reported psychosocial function

  5. Change from baseline in Heart Rate Variability [ Time Frame: Throughout the entire 6-week intervention ]
    Collected using emWave device



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03103243


Contacts
Contact: Tracie Kostelac 434-243-0563 tlk5d@virginia.edu
Contact: Andrea Coppola 434-243-2323 amc2dh@virginia.edu

Locations
United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22903
Contact: Tracie L Kostelac    434-243-0563    tlk5d@virginia.edu   
Contact: Andrea Coppola    434-243-2323    amc2dh@virginia.edu   
Principal Investigator: James A Coan, Ph.D.         
Sponsors and Collaborators
University of Virginia
Lupus Research Alliance
Investigators
Principal Investigator: James A Coan, Ph.D. University of Virginia

Responsible Party: James A. Coan, Ph.D., Associate Professor, Psychology, University of Virginia
ClinicalTrials.gov Identifier: NCT03103243     History of Changes
Other Study ID Numbers: 19671
First Posted: April 6, 2017    Key Record Dates
Last Update Posted: September 1, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by James A. Coan, Ph.D., University of Virginia:
Lupus
SLE
Erythematosus

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases