CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 26 enrolled
Drug / intervention
Mindfulness- Based Interventionother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04305418
NCT04305418N/ACompleted

The Efficacy of Mindfulness- Based Intervention for Systemic Lupus Erythematosus (SLE): a Randomized Control Trial

Bar-Ilan University, Israel·interventional·Posted Mar 12, 2020·Updated Mar 12, 2020

In Brief

A clinical study evaluating Mindfulness- Based Intervention for Psychological. Completed, enrolled 26 participants across 2 sites.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPsychological
CountriesIsrael
Collaborators--

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedMar 12, 2020
Enrollment StartJan 23, 2017
Primary CompletionSep 4, 2018
Study CompletionSep 8, 2018
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 6.3 years ago

Interventions

Mindfulness- Based Interventionother

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.