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Contemplation-Based Intervention and Health Outcomes RCT in Lupus Patients

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ClinicalTrials.gov Identifier: NCT04032496
Recruitment Status : Not yet recruiting
First Posted : July 25, 2019
Last Update Posted : August 6, 2019
Sponsor:
Collaborators:
University Health Network, Toronto
University of Virginia
Information provided by (Responsible Party):
William Cunningham, University of Toronto

Brief Summary:
The objective of this study is to test the efficacy of an innovative contemplative-based and caregiver-inclusive intervention can modify pathogenic processes in systemic lupus erythematosus (SLE) compared to a psychoeducation-based intervention. 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. 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 mindfulness-based 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. Although we expect our mindfulness-based intervention to outperform our psychoeducation intervention, we note that the psychoeducation intervention is much closer to treatment as usual (especially insofar as many lupus patients are provided no psychosocial intervention whatever), and to that degree can reasonably be considered our best initial point of comparison. In practice, most patients would be provided medication and some basic information about living with the disease, as well as, perhaps, some additional guidance about coping with chronic stress and pain. We believe that our comparison condition goes beyond this to provide a bona fide intervention in itself.

Condition or disease Intervention/treatment Phase
Lupus Erythematosus, Systemic Behavioral: Contemplative-Based Intervention for People Living with SLE Behavioral: Health Enhancement Program (HEP) Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: A Randomized Controlled Trial to Investigate a Contemplation-Based Intervention and Health Outcomes in Systemic Lupus Erythematosus Patients
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus

Arm Intervention/treatment
Experimental: Mindfulness Intervention
Participants in this arm will participate in the Contemplative-Based Intervention for People Living with SLE intervention in addition to one baseline fMRI and blood analysis and one post-treatment fMRI and blood analysis.
Behavioral: Contemplative-Based Intervention for People Living with SLE
Intervention sessions will follow a 6-week format consisting of weekly in-person sessions as well as guided homework to encourage practice at home. Some mindfulness practices that will be included are meditation, group exercise (yoga), group discussions, and deep breathing. Both participants diagnosed with SLE as well as caregivers will participate in the intervention sessions. 5 sessions will be approximately 2 hours long, while the final session will be approximately 4 hours long. Each intervention group will include approximately 4 participants with SLE and 4 caregivers.

Active Comparator: HEP Intervention
Participants in this arm will participate in the Health Enhancement Program (HEP) intervention in addition to one baseline fMRI and blood analysis and one post-treatment fMRI and blood analysis.
Behavioral: Health Enhancement Program (HEP)
The HEP was designed to create an active control for mindfulness-based stress reduction (MBSR) interventions. The structure of this intervention will mirror that of the other arm of this study, but will lack the mindfulness component. The HEP includes topics such as physical activity, functional movement, music therapy, and nutrition education.




Primary Outcome Measures :
  1. Change from baseline in systemic lupus erythematosus (SLE) disease activity [ Time Frame: Baseline Assessment within 2 weeks prior to intervention, within 2 weeks after intervention ]
    Change from baseline SLE Disease Activity Index 2000 (SLEDAI-2K) total score (range from 0 to 105 with higher values representing worse outcomes). Total score represents the sum of the central nervous system, vasculitis, musculoskeletal, renal, skin, serosal, immunologic, fever, and hematologic subscales.


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 ]
    Change in brain activity during functional MRI handholding task

  2. Change from baseline in organ-specific SLE disease activity (central nervous system subscale) [ Time Frame: Baseline Assessment within 2 weeks prior to intervention, within 2 weeks after intervention ]
    Change from baseline in SLEDAI-2K central nervous system score (range 0-56 with higher values representing worse outcomes).

  3. Change from baseline in organ-specific SLE disease activity (vasculitis subscale) [ Time Frame: Baseline Assessment within 2 weeks prior to intervention, within 2 weeks after intervention ]
    Change from baseline in SLEDAI-2K vasculitis score (range 0-8 with higher values representing worse outcomes).

  4. Change from baseline in organ-specific SLE disease activity (musculoskeletal subscale) [ Time Frame: Baseline Assessment within 2 weeks prior to intervention, within 2 weeks after intervention ]
    Change from baseline in SLEDAI-2K musculoskeletal score (range 0-8 with higher values representing worse outcomes).

  5. Change from baseline in organ-specific SLE disease activity (renal subscale) [ Time Frame: Baseline Assessment within 2 weeks prior to intervention, within 2 weeks after intervention ]
    Change from baseline in SLEDAI-2K renal score (range 0-16 with higher values representing worse outcomes).

  6. Change from baseline in organ-specific SLE disease activity (skin subscale) [ Time Frame: Baseline Assessment within 2 weeks prior to intervention, within 2 weeks after intervention ]
    Change from baseline in SLEDAI-2K skin score (range 0-6 with higher values representing worse outcomes).

  7. Change from baseline in organ-specific SLE disease activity (serosal subscale) [ Time Frame: Baseline Assessment within 2 weeks prior to intervention, within 2 weeks after intervention ]
    Change from baseline in SLEDAI-2K serosal score (range 0-4 with higher values representing worse outcomes).

  8. Change from baseline in organ-specific SLE disease activity (immunologic subscale) [ Time Frame: Baseline Assessment within 2 weeks prior to intervention, within 2 weeks after intervention ]
    Change from baseline in SLEDAI-2K immunologic score (range 0-4 with higher values representing worse outcomes).

  9. Change from baseline in organ-specific SLE disease activity (fever subscale) [ Time Frame: Baseline Assessment within 2 weeks prior to intervention, within 2 weeks after intervention ]
    Change from baseline in SLEDAI-2K fever score (range 0-1 with higher values representing worse outcomes).

  10. Change from baseline in organ-specific SLE disease activity (hematologic subscale) [ Time Frame: Baseline Assessment within 2 weeks prior to intervention, within 2 weeks after intervention ]
    Change from baseline in SLEDAI-2K hematologic score (range 0-2 with higher values representing worse outcomes).

  11. Change from baseline in erythrocyte sedimentation rate (ESR) [ Time Frame: Baseline Assessment within 2 weeks prior to intervention, within 2 weeks after intervention ]
    Abnormal lab values for ESR (mm/hr)

  12. Change from baseline in antinuclear antibodies (ANA) [ Time Frame: Baseline Assessment within 2 weeks prior to intervention, within 2 weeks after intervention ]
    Abnormal lab values for ANA titer

  13. Change from baseline in white blood cell count (WBC), red blood cell count (RBC), platelet levels, and nucleated RBC count [ Time Frame: Baseline Assessment within 2 weeks prior to intervention, within 2 weeks after intervention ]
    Abnormal lab values for WBC, RBC, platelet levels and nucleated RBC count (amount per microliter)

  14. Change from baseline in hemoglobin levels and mean corpuscular hemoglobin concentration (MCHC) [ Time Frame: Baseline Assessment within 2 weeks prior to intervention, within 2 weeks after intervention ]
    Abnormal lab values for hemoglobin levels and mean corpuscular hemoglobin concentration (MCHC) (g/dL)

  15. Change from baseline in hematocrit levels, red cell distribution width (RDW), and nucleated red blood cell percentage [ Time Frame: Baseline Assessment within 2 weeks prior to intervention, within 2 weeks after intervention ]
    Abnormal lab values for hematocrit levels, RDW, and nucleated red blood cell percentage (%)

  16. Change from baseline in mean corpuscular volume (MCV) and mean platelet volume (MPV) [ Time Frame: Baseline Assessment within 2 weeks prior to intervention, within 2 weeks after intervention ]
    Abnormal lab values for MCV and MPV (fL)

  17. Change from baseline in mean corpuscular hemoglobin (MCH) [ Time Frame: Baseline Assessment within 2 weeks prior to intervention, within 2 weeks after intervention ]
    Abnormal lab values for MCH (pg)

  18. Change from baseline in blood sodium, potassium, chloride, carbon dioxide, and anion gap (mmol/L) [ Time Frame: Baseline Assessment within 2 weeks prior to intervention, within 2 weeks after intervention ]
    Abnormal lab values for baseline in blood sodium, potassium, chloride, carbon dioxide, and anion gap (mmol/L)

  19. Change from baseline in blood urea nitrogen, creatinine, glucose, and calcium levels [ Time Frame: Baseline Assessment within 2 weeks prior to intervention, within 2 weeks after intervention ]
    Abnormal lab values for blood urea nitrogen, creatinine, glucose, and calcium levels (mg/dL)

  20. Change from baseline in high sensitivity C-reactive protein (CRP) [ Time Frame: Baseline Assessment within 2 weeks prior to intervention, within 2 weeks after intervention ]
    Abnormal lab values for CRP (mg/L)

  21. Change from baseline in complement C3 and complement C4 [ Time Frame: Baseline Assessment within 2 weeks prior to intervention, within 2 weeks after intervention ]
    Abnormal lab values for complement C3 and complement C4 (mg/dL)

  22. Change from baseline in cytokine panel (tumor necrosis factor alpha; interleukin 2, 2 receptor (CD25) soluble, 12, gamma, 4, 5, 10, 13, 17, 1 beta, 6, 8) [ Time Frame: Baseline Assessment within 2 weeks prior to intervention, within 2 weeks after intervention ]
    Abnormal lab values for cytokine panel (pg/mL)

  23. Adult attachment style questionnaire - closeness subscale (AAS) [ Time Frame: Baseline Assessment within 2 weeks prior to intervention, within 2 weeks after intervention ]
    Change from baseline in AAS scores (range from 6-30 with higher scores indicating better outcomes)

  24. Adverse childhood experiences questionnaire (ACE) [ Time Frame: Baseline Assessment within 2 weeks prior to intervention, within 2 weeks after intervention ]
    Change from baseline in ACE scores (ranging from 0-10 with higher scores suggesting worse outcomes)

  25. Brief Health Mindset Scale (BHMS) [ Time Frame: Baseline Assessment within 2 weeks prior to intervention, within 2 weeks after intervention ]
    Change from baseline in BHMS scores (ranging from 6-36, with higher scores reflecting more adaptive mindsets about health)

  26. Center for Epidemiological Studies Depression Scale (CESD-R) [ Time Frame: Baseline Assessment within 2 weeks prior to intervention, within 2 weeks after intervention ]
    Change from baseline in CESD-R scores (ranging from 0-80 with higher scores representing worse outcomes. Sum of sadness/dysphoria, loss of interest/anhedonia, appetite, sleep, thinking/concentration, guilt/worthlessness, tired/fatigue, movement/agitation, suicidal ideation subscales).

  27. Inclusion of Other in Self Scale (IOS) [ Time Frame: Baseline Assessment within 2 weeks prior to intervention, within 2 weeks after intervention ]
    Change from baseline in IOS scores (ranging from 1-7 with higher scores representing more relationship closeness)

  28. Interpersonal Reactivity Index (IRI) [ Time Frame: Baseline Assessment within 2 weeks prior to intervention, within 2 weeks after intervention ]
    Change from baseline in IRI scores (ranging from 0-112 with higher scores indicating higher empathy. Sum of empathic concern, perspective-taking, fantasy, and personal distress subscales).

  29. Interpersonal Regulation Questionnaire (IRQ) [ Time Frame: Baseline Assessment within 2 weeks prior to intervention, within 2 weeks after intervention ]
    Change from baseline in IRQ scores (ranging from 16-112, with higher scores reflecting better outcomes. Total score is sum of negative-tendency, negative-efficacy, positive-tendency, and positive-efficacy subscales.)

  30. MacArthur Scales of Subjective Social Status (community ladder) [ Time Frame: Baseline Assessment within 2 weeks prior to intervention, within 2 weeks after intervention ]
    Change from baseline in MacArthur Scales of Subjective Social Status (community ladder score ranging from 1-10 with higher scores indicating better outcomes)

  31. MacArthur Scales of Subjective Social Status (socioeconomic status ladder) [ Time Frame: Baseline Assessment within 2 weeks prior to intervention, within 2 weeks after intervention ]
    Change from baseline in MacArthur Scales of Subjective Social Status (socioeconomic status ladder score ranging from 1-10 with higher scores indicating better outcomes)

  32. Caregiver Burden Questionnaire (CBQ) [ Time Frame: Baseline Assessment within 2 weeks prior to intervention, within 2 weeks after intervention ]
    Change from baseline in CBQ scores (ranging from 0-88 with higher scores representing worse outcomes)

  33. Multidimensional Scale of Perceived Social Support (MSPSS) [ Time Frame: Baseline Assessment within 2 weeks prior to intervention, within 2 weeks after intervention ]
    Change from baseline in MSPSS scores (ranging from 12-84 with higher scores indicating better outcomes. Sum of family, friends, and significant other subscales)

  34. Pain Catastrophizing Scale (PCS) [ Time Frame: Baseline Assessment within 2 weeks prior to intervention, within 2 weeks after intervention ]
    Change from baseline in PCS scores (ranging from 0-52 with higher scores representing worse outcomes. Sum of rumination, magnification, and helplessness subscales)

  35. Ruminative Responses Scale (RRS) [ Time Frame: Baseline Assessment within 2 weeks prior to intervention, within 2 weeks after intervention ]
    Change from baseline in RRS scores (ranging from 10-40 with higher scores representing worse outcomes. Sum of brooding and reflection subscales).

  36. Social Interaction Phobia Scale (SIPS) [ Time Frame: Baseline Assessment within 2 weeks prior to intervention, within 2 weeks after intervention ]
    Change from baseline in SIPS scores (ranging from 0-56 with higher scores representing worse outcomes. Sum of social interaction anxiety, fear of overt evaluation, and fear of attracting attention subscales).

  37. State Trait Anxiety Inventory (STAI) [ Time Frame: Baseline Assessment within 2 weeks prior to intervention, within 2 weeks after intervention ]
    Change from baseline in STAI scores (ranging from 40-160 with higher scores representing worse outcomes. Sum of trait anxiety and state anxiety subscales)

  38. Ten Item Personality Inventory (TIPI) [ Time Frame: Baseline Assessment within 2 weeks prior to intervention, within 2 weeks after intervention ]
    Change from baseline in TIPI scores on each of conscientiousness, openness to experience, extraversion, agreeableness, and neuroticism personality traits (ranging from 1-7 on each personality trait with higher scores representing more expression of each personality trait.)

  39. Toronto Mindfulness Scale (TMS) [ Time Frame: Baseline Assessment within 2 weeks prior to intervention, within 2 weeks after intervention ]
    Change from baseline in TMS scores (ranging from 0-52 with higher scores representing greater mindfulness. Sum of curiosity and decentering subscales)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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 years of age or 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
  • Must be a participant in The University of Toronto Clinic and Database Research Program - Prognosis and Genetic Studies in Systemic Lupus Erythematosus
  • Must be able to access the Internet regularly

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)
  • 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)
  • 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 portion of the study.
  • Is not a participant in The University of Toronto Clinic and Database Research Program - Prognosis and Genetic Studies in Systemic Lupus Erythematosus

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): NCT04032496


Contacts
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Contact: Moe Zandy, MPH 416-603-5800 ext 2352 Moe.Zandy@uhnresearch.ca

Sponsors and Collaborators
University of Toronto
University Health Network, Toronto
University of Virginia
Investigators
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Principal Investigator: William A Cunningham, PhD University of Toronto

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Responsible Party: William Cunningham, Professor, University of Toronto
ClinicalTrials.gov Identifier: NCT04032496     History of Changes
Other Study ID Numbers: 34709
First Posted: July 25, 2019    Key Record Dates
Last Update Posted: August 6, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases