Mindfulness- Based Intervention for Systemic Lupus Erythematosus (SLE) Patients
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|ClinicalTrials.gov Identifier: NCT04305418|
Recruitment Status : Completed
First Posted : March 12, 2020
Last Update Posted : March 12, 2020
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Systemic lupus erythematosus (SLE) is a rheumatic autoimmune disease, involving chronic pain, fatigue, movement difficulties, and is often accompanied by tremendous psychological and psychiatric difficulties. Mindfulness-based Intervention (MBI), is a mind-body intervention, which has been documented in several studies as effective among stress- related diseases, such as crohn's disease.
Nevertheless, not much is known about the efficiency of MBI among SLE patients and about the mechanisms of change through which MBI works. In the present study, the investigators are focusing on different cognitive mechanisms and their role in MBI action.
The study is a randomized-controlled trial. 26 Patients diagnosed with SLE (Mean age=41.26) were randomly assigned to either a 10-weeks MBI intervention (N=15) or a waitlist-control (WL;N=11).4 central measurements points were conducted through the study, which included physiological and psychological variables: at the beginning of the intervention (T1), in the middle of the intervention (T2) at the end of the intervention (T3) and one 6 months follow- up measurement after the termination of the intervention (T4). additionally, participant's blood test has been taken at the beginning and at the end of the intervention.
|Condition or disease||Intervention/treatment||Phase|
|Psychological||Other: Mindfulness- Based Intervention||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||26 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||The current study is a randomized- Control Trial (RCT), 26 patients diagnosed with Systemic Lupus Erythematosus (SLE) were randomly assigned either to mindfulness-based intervention group (MBI) or to a wait-list control group (WL).|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
Participant, therapists and outcome assesors are blind to the condition the individual participant was assigned to, by encrypting the names of the individual into a number-letter codes.
The therapists led the intervention group was not aware of the participants condition.
|Official Title:||The Efficacy of Mindfulness- Based Intervention for Systemic Lupus Erythematosus (SLE): a Randomized Control Trial|
|Actual Study Start Date :||January 23, 2017|
|Actual Primary Completion Date :||September 4, 2018|
|Actual Study Completion Date :||September 8, 2018|
Experimental: Mindfulness- Based Intervention (MBI)
In MBI arm, patients received mindfulness- based intervention, a psychological mind- body intervention, focusing on stress reduction,. the intervention was led by a licensed clinical therapist and mindfulness specialist, who was trained in MBSR at Bangor University.
Other: Mindfulness- Based Intervention
Mindfulness- Based Intervention in a psychological intervention, based on mind- body connection.
The protocol includes a 10- weeks program, with weekly group sessions of 2 hours and one all-day session after seven weeks. The intervention have standardized core elements consisting of different mental and physical mindfulness exercises: 1) body-scan exercises (paying close attention to all body parts, from the feet to the head), 2) mental exercises focusing one's attention on breathing, 3) physical exercises with focus on being aware of bodily sensations and one's own limits during the exercises, and 4) practicing being fully aware during everyday activities by using the breath as an anchor for attention. Essential to all parts of the program is developing an accepting and non-reactive attitude to what one experiences in each moment.
No Intervention: Wait- List Controls (WL)
Patients in wait- list control arm received no active treatment during their 10-weeks waiting period. At the end of that period received the exact intervention as the study group.
- Systemic Lupus Activity Questionnaire [ Time Frame: Through study completion, an average of 9 month ]Systemic Lupus Activity Questionnaire (SLAQ), to assess self-reported lupus activity . An analog to the Systemic Lupus Activity Measure (SLAM), the SLAQ includes 24 questions related to disease activity in SLE. Items are weighted and aggregated in a manner analogous to the scoring system used in the SLAM, and scores range from 0-44, with higher scores indicating greater disease activity. The SLAQ is highly correlated with physicians' ratings of disease activity, and other health indices, including the Short Form 12 Health Survey physical component summary and the Short Form 36 physical functioning subscale.
- PSS (Perceived Stress Scale) [ Time Frame: Through study completion, an average of 9 month ]A widely-used and well-validated 10-item scale that measures the degree to which situations in one's life over the past month are appraised as unpredictable, uncontrollable and overwhelming. It posits that people appraise potentially threatening or challenging events in relation to their available coping resources. Items are rated on a Likert scale ranging from 0 (never) to 4 (very often). A higher score indicates a greater degree of perceived stress. The PSS was often found to possess very good psychometric properties.
- PHQ-9 (The Patient Health Questionnaire-9 ) [ Time Frame: Through study completion, an average of 9 month ]PHQ-9 is a self-administered questionnaire used to assess major depression symptoms, which scores each of the 9 DSM-IV criteria as "0" (not at all) to "3" (nearly every day). It can yield either a continuous score, or a probable major depressive disorder diagnosis using a cut-off of 10. The sensitivity and specificity of the PHQ-9 compare favorably with structured psychiatric interviews and the Cronbach alpha was found to be 0.89 in a sample of primary care patients.
- FFMQ (Five Facet Mindfulness Questionnaire) [ Time Frame: Through study completion, an average of 9 month ]FFMQ derived from a factor analysis of questionnaires measuring a trait-like general tendency to be mindful in daily life. It yield five scoring scales that appear to represent elements of mindfulness as it is currently conceptualized: observing, describing, acting with awareness, non-judging of inner experience, and non- reactivity to inner experience. FFMQ consists of 39 items, items are rated on a Likert scale ranging from 1 (never or very rarely true) to 5 (very often or always true). The FFMQ has been shown to have good internal consistency and significant relationships in the predicted directions with a variety of constructs related to mindfulness.
- PIPS (Psychological Inflexibility in Pain Scale) [ Time Frame: Through study completion, an average of 9 month ]PIPS is a 12-item scale developed to assess target variables in exposure and acceptance-oriented treatments of chronic pain ("I postpone things because of my pain"). The subscales measure avoidance (eight items) and cognitive fusion (four items). Items can be answered on a 7-point Likert scale (1=never true to 7=always true). The total score ranges from 12 to 84 points. Higher scores indicate greater psychological inflexibility. Studies showed good model fit and internal consistencies.
- PCS (The pain catastrophizing scale) [ Time Frame: Through study completion, an average of 9 month ]The PCS is a self-administered questionnaire that consists of 13 items to assess the extent of the patient's catastrophizing thoughts and behaviors. It comprises three subscales: helplessness, magnification, and rumination. The questionnaire is completed in relation to the patient's thoughts and feelings when they are in pain. The scores for the subscales are given by the sum of the corresponding items, and the total score is computed by summation of all items. The PCS score ranges from 0 to 52 points.
- EQ (Experiences Questionnaire) [ Time Frame: Through study completion, an average of 9 month ]EQ is a 20-item self-report scale measuring decentering, in which participants rate items on a 7-point Likert-type scale (1 = never to 7 = all the time). It evaluates an individual's ability to decenter, namely, the ability to regard thoughts and feelings as temporary and transient. The EQ focuses on three facets of decentering: the ability to view one's self as separate from one's thoughts, the ability to non-judgmentally observe one's negative experiences without habitually reacting, and the capacity for self-compassion. Multiple studies have demonstrated sound psychometric properties of the EQ.
- BAI (The Beck Anxiety Inventory) [ Time Frame: Through study completion, an average of 9 month ]BAI is a 21-item questionnaire that measures cognitive and somatic symptoms of anxiety, with higher scores indicating increased anxiety, (range 0-63). Sample items include "unable to relax" and "heart pounding or racing." Good psychometric properties have been demonstrated among college, medical, and psychiatric samples. The BAI is a 21-item scale that measures cognitive, somatic, and affective symptoms of anxiety.
- BAQ (Body awareness questionnaire) [ Time Frame: Through study completion, an average of 9 month ]The 18-item Body Awareness Questionnaire assessed reported attentiveness to normal non-emotive body processes, sensitivity to body cycles/rhythms, ability to detect small changes in normal functioning, and to anticipate bodily reactions ("I am aware of a cycle in my activity level throughout the day", and "I notice specific bodily reactions to being over hungry"). It is a 7-point Likert-type scale (1 = Not at all true of me to 7 = Very true of me). Studies reported good reliability and validity of the BAQ. The total score ranges from 18 to 126 points. Higher scores indicate greater body awareness.
- The WHOQOL-BREF (The World Health Organization Quality of Life) [ Time Frame: Through study completion, an average of 9 month ]WHOQOL is an abbreviated 26-item version of the WHOQOL-100, on a scale of 1-5. It contains one general QOL item, one general health item, and 24 specific items-one item from each of the 24 QOL facets of the WHOQOL-100. The 24 specific items cover four broad domains: physical, psychological, social, and environmental quality of life. The items are answered on five-point scales, which assess the intensity, capacity, frequency, and evaluation of QOL facets with respect to the last two weeks. Negatively keyed items are reversely scored, so that higher values indicate better QOL.
- VAS Pain (Visual Analog Scale for Pain) [ Time Frame: Through study completion, an average of 9 month ]The VAS pain is a self- report measure continuous scale, comprised of a horizontal line ranged of 0-100. VAS was based on 3 single- item continuous scale, for pain intensity, shame in one's disease and the third measured the levels of how much the disease has taken over the patients identity. The VAS is the most commonly used measure for assessing levels of pain by physicians in medical setting.
- DAI-10 (Drug Attitude Inventory) [ Time Frame: Through study completion, an average of 9 month ]The DAI includes a series of 10 questions, each with true/false answers, regarding the adherent of patients to their prescribed medication, and pertaining to various aspects of the patient's perceptions and experiences of treatment. The original scale consists of 30 questions, but a short form consisting of 10 questions has also been validated.
- Home Practice Diary [ Time Frame: Through study completion, an average of 9 month ]In order to comprehensively assess mindfulness practice at home, participants would fill out a daily home practice diary, which will include the date, time, type, and duration of both formal and informal mindfulness home practice, along with any comments on their experience. This home practice form is commonly used in MBSR interventions.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- confirmation of a clinical diagnosis of Lupus by the patient's own physician
- age 18 years or older
- Hebrew speakers
- physical ability to attend group intervention sessions
- psychological ability to practice mindfulness (no cognitive extreme impairments, no psychosis, no suicidal tendencies)
- serious mental health condition (such as suicidal state, alcohol and drug abuse, schizophrenia)
- serious physical condition that would not enable participation
- participation in another study.
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): NCT04305418
|Chaim Sheba Medical Center|
|Ramat Gan, Israel, 52621|
|Bar- Ilan University|
|Ramat Gan, Israel, 5290002|
|Responsible Party:||Danny Horesh, Senior lecturer and head of the Trauma and Stress Research Lab at Bar-Ilan University's Department of Psychology., Bar-Ilan University, Israel|
|Other Study ID Numbers:||
|First Posted:||March 12, 2020 Key Record Dates|
|Last Update Posted:||March 12, 2020|
|Last Verified:||March 2020|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Yes|
|Plan Description:||IPD would be available to other researchers, including Study Protocol, Statistical Analysis Plan, Informed Consent Form, Clinical Study Report and Analytic Code through e- mail or publications.|
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Systemic Lupus Erythematosus (SLE)
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Immune System Diseases