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

Primary Purpose

Lupus Erythematosus, Systemic

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Mindfulness Based Group Sessions

About this trial

This is an interventional treatment trial for Lupus Erythematosus, Systemic focused on measuring Lupus, SLE, Erythematosus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

University of Virginia

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Intervention

Arm Description

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.

Outcomes

Primary Outcome Measures

Change from baseline in blood

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

Secondary Outcome Measures

Change from baseline in brain activity during functional MRI

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)

Change from baseline in Patient Reported Outcomes

Patient-reported change in health and symptoms

Change from baseline in SLE disease activity

Systemic Lupus Activity Questionnaire (SLAQ)

Change from baseline in psychosocial function

Self reported psychosocial function

Change from baseline in Heart Rate Variability

Collected using emWave device

Full Information

NCT ID

NCT03103243

First Posted

March 22, 2017

Last Updated

March 12, 2019

Sponsor

University of Virginia

Collaborators

Lupus Research Alliance

1. Study Identification

Unique Protocol Identification Number

NCT03103243

Brief Title

Pilot Study to Investigate Contemplative Intervention in Lupus Patients

Acronym

LUPP

Official Title

A Pilot Study to Investigate a Contemplation-Based Intervention and Health Outcomes in Systemic Lupus Erythematosus Patients

Study Type

Interventional

2. Study Status

Record Verification Date

March 2019

Overall Recruitment Status

Completed

Study Start Date

April 27, 2017 (Actual)

Primary Completion Date

June 4, 2018 (Actual)

Study Completion Date

June 4, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Virginia

Collaborators

Lupus Research Alliance

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lupus Erythematosus, Systemic

Keywords

Lupus, SLE, Erythematosus

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intervention

Arm Type

Other

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Mindfulness Based Group Sessions

Intervention Description

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 Measure Information:

Title

Change from baseline in blood

Description

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

Time Frame

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

Secondary Outcome Measure Information:

Title

Change from baseline in brain activity during functional MRI

Description

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)

Time Frame

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

Title

Change from baseline in Patient Reported Outcomes

Description

Patient-reported change in health and symptoms

Time Frame

Baseline Assessment, within 2 weeks prior to intervention, throughout the 6-week intervention, within 2 weeks after intervention

Title

Change from baseline in SLE disease activity

Description

Systemic Lupus Activity Questionnaire (SLAQ)

Time Frame

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

Title

Change from baseline in psychosocial function

Description

Self reported psychosocial function

Time Frame

Baseline Assessment, within 2 weeks prior to intervention, throughout the 6-week intervention, within 2 weeks after intervention

Title

Change from baseline in Heart Rate Variability

Description

Collected using emWave device

Time Frame

Throughout the entire 6-week intervention

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

James A Coan, Ph.D.

Organizational Affiliation

University of Virginia

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Virginia

City

Charlottesville

State/Province

Virginia

ZIP/Postal Code

22903

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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Pilot Study to Investigate Contemplative Intervention in Lupus Patients

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