A Randomized Controlled Trial to Investigate a Contemplation-Based Intervention and Health Outcomes in Systemic Lupus Erythematosus Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 主要终点
- Change from baseline in systemic lupus erythematosus (SLE) disease activity
研究概览
简要总结
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.
详细描述
METHODS: A randomized controlled trial of 50 SLE patients in which subjects receive either a 6-week MBI treatment (n=25) or a 6-week psychoeducation treatment (n=25).
SCREENING: At Visit 1, participants who are deemed eligible for the study will be assigned to either a mindfulness-based intervention group or a psychoeducation intervention group. Participants will also complete the following questionnaires, which will also be administered throughout the intervention schedule:
- Adverse Childhood Experience (ACE)
- Adult Attachment Style Questionnaire (AAS; closeness subscale)
- Brief Health Mindset Scale (BHMS)
- Center for Epidemiological Studies Depression Scale Revised (CESD-R)
- Inclusion of Other Self (IOS)
- Interpersonal Reactivity Index (IRI; empathic concern and perspective-taking subscales)
- Interpersonal Regulation Questionnaire (IRQ)
- LupusPRO (patient only)
- MacArthur Scales of Subjective Social Status (Community and Socioeconomic Status)
- Caregiver Burden Questionnaire (support person only)
- Multidimensional Scale of Perceived Social Support (MSPSS)
- Pain Catastrophizing Scale (PCS)
- Ruminative Responses Scale (RRS; short form)
- Social Interaction Phobia Scale (SIPS)
- State Trait Anxiety Inventory (STAI-T, STAI-S)
- Ten Item Big Five Questionnaire
- Toronto Mindfulness Scale (TMS)
- Lupus Quality of Life
- CAM Health Belief Questionnaire
INTERVENTIONS: All participants will complete either a 6-week mindfulness-based intervention or a 6-week psychoeducation intervention. All sessions will be in-person in a group setting, and accompanied by homework. For both interventions, participants will practice what they learned on a daily basis as their homework. However, the mindfulness intervention may also have video/audio homework to complete. Sessions 1-5 will last approximately 2 hours each. The final (6th) session will be a retreat that will last approximately 4 hours. Questionnaire data will be collected throughout the intervention.
ASSESSMENTS: Assessment visits 1 and 9 will be performed by rheumatologists and include: complete history, physical examination, information about SLE drug treatment and laboratory examination. Lupus disease activity and damage will be measured by Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) and systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index (SDI) respectively. Information on socio-demographics, clinical variables (SLEDAI-2K and SDI), co-morbidities (dyslipidemia, atherosclerosis, cerebrovascular disease, and others) are collected as part of the and will be made available for the analysis in this study. Lupus serology (including C3/C4, anti-ds DNA antibodies) and routine blood test (including complete blood count test and chemistry panel) are also collected regularly during the patients' visits to the clinic and will be made available for the analysis in this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Change from baseline in systemic lupus erythematosus (SLE) disease activity
时间窗: 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.
次要结局
- Change from baseline in organ-specific SLE disease activity (immunologic subscale)(Baseline Assessment within 2 weeks prior to intervention, within 2 weeks after intervention)
- Change from baseline in organ-specific SLE disease activity (hematologic subscale)(Baseline Assessment within 2 weeks prior to intervention, within 2 weeks after intervention)
- 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 complement C3 and complement C4(Baseline Assessment within 2 weeks prior to intervention, within 2 weeks after intervention)
- 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)(Baseline Assessment within 2 weeks prior to intervention, within 2 weeks after intervention)
- Change from baseline in organ-specific SLE disease activity (musculoskeletal subscale)(Baseline Assessment within 2 weeks prior to intervention, within 2 weeks after intervention)
- Change from baseline in organ-specific SLE disease activity (serosal subscale)(Baseline Assessment within 2 weeks prior to intervention, within 2 weeks after intervention)
- Change from baseline in erythrocyte sedimentation rate (ESR)(Baseline Assessment within 2 weeks prior to intervention, within 2 weeks after intervention)
- Change from baseline in antinuclear antibodies (ANA)(Baseline Assessment within 2 weeks prior to intervention, within 2 weeks after intervention)
- Change from baseline in white blood cell count (WBC), red blood cell count (RBC), platelet levels, and nucleated RBC count(Baseline Assessment within 2 weeks prior to intervention, within 2 weeks after intervention)
- Change from baseline in hemoglobin levels and mean corpuscular hemoglobin concentration (MCHC)(Baseline Assessment within 2 weeks prior to intervention, within 2 weeks after intervention)
- Change from baseline in hematocrit levels, red cell distribution width (RDW), and nucleated red blood cell percentage(Baseline Assessment within 2 weeks prior to intervention, within 2 weeks after intervention)
- Change from baseline in mean corpuscular volume (MCV) and mean platelet volume (MPV)(Baseline Assessment within 2 weeks prior to intervention, within 2 weeks after intervention)
- Change from baseline in organ-specific SLE disease activity (renal subscale)(Baseline Assessment within 2 weeks prior to intervention, within 2 weeks after intervention)
- Change from baseline in organ-specific SLE disease activity (skin subscale)(Baseline Assessment within 2 weeks prior to intervention, within 2 weeks after intervention)
- Change from baseline in organ-specific SLE disease activity (fever subscale)(Baseline Assessment within 2 weeks prior to intervention, within 2 weeks after intervention)
- Change from baseline in organ-specific SLE disease activity (central nervous system subscale)(Baseline Assessment within 2 weeks prior to intervention, within 2 weeks after intervention)
- Change from baseline in organ-specific SLE disease activity (vasculitis subscale)(Baseline Assessment within 2 weeks prior to intervention, within 2 weeks after intervention)
- Change from baseline in mean corpuscular hemoglobin (MCH)(Baseline Assessment within 2 weeks prior to intervention, within 2 weeks after intervention)
- Change from baseline in blood sodium, potassium, chloride, carbon dioxide, and anion gap (mmol/L)(Baseline Assessment within 2 weeks prior to intervention, within 2 weeks after intervention)
- Change from baseline in high sensitivity C-reactive protein (CRP)(Baseline Assessment within 2 weeks prior to intervention, within 2 weeks after intervention)
- Adult attachment style questionnaire - closeness subscale (AAS)(Baseline Assessment within 2 weeks prior to intervention, within 2 weeks after intervention)
- Interpersonal Reactivity Index (IRI)(Baseline Assessment within 2 weeks prior to intervention, within 2 weeks after intervention)
- Interpersonal Regulation Questionnaire (IRQ)(Baseline Assessment within 2 weeks prior to intervention, within 2 weeks after intervention)
- MacArthur Scales of Subjective Social Status (community ladder)(Baseline Assessment within 2 weeks prior to intervention, within 2 weeks after intervention)
- Change from baseline in blood urea nitrogen, creatinine, glucose, and calcium levels(Baseline Assessment within 2 weeks prior to intervention, within 2 weeks after intervention)
- Center for Epidemiological Studies Depression Scale (CESD-R)(Baseline Assessment within 2 weeks prior to intervention, within 2 weeks after intervention)
- Inclusion of Other in Self Scale (IOS)(Baseline Assessment within 2 weeks prior to intervention, within 2 weeks after intervention)
- Caregiver Burden Questionnaire (CBQ)(Baseline Assessment within 2 weeks prior to intervention, within 2 weeks after intervention)
- Multidimensional Scale of Perceived Social Support (MSPSS)(Baseline Assessment within 2 weeks prior to intervention, within 2 weeks after intervention)
- Adverse childhood experiences questionnaire (ACE)(Baseline Assessment within 2 weeks prior to intervention, within 2 weeks after intervention)
- Brief Health Mindset Scale (BHMS)(Baseline Assessment within 2 weeks prior to intervention, within 2 weeks after intervention)
- MacArthur Scales of Subjective Social Status (socioeconomic status ladder)(Baseline Assessment within 2 weeks prior to intervention, within 2 weeks after intervention)
- Pain Catastrophizing Scale (PCS)(Baseline Assessment within 2 weeks prior to intervention, within 2 weeks after intervention)
- Toronto Mindfulness Scale (TMS)(Baseline Assessment within 2 weeks prior to intervention, within 2 weeks after intervention)
- Ruminative Responses Scale (RRS)(Baseline Assessment within 2 weeks prior to intervention, within 2 weeks after intervention)
- Social Interaction Phobia Scale (SIPS)(Baseline Assessment within 2 weeks prior to intervention, within 2 weeks after intervention)
- State Trait Anxiety Inventory (STAI)(Baseline Assessment within 2 weeks prior to intervention, within 2 weeks after intervention)
- Ten Item Personality Inventory (TIPI)(Baseline Assessment within 2 weeks prior to intervention, within 2 weeks after intervention)
研究者
William Cunningham
Professor
University of Toronto