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NCT04304664

Mindfulness- Based Intervention for Fibromyalgia Patients

Completed NA Last updated 11 March 2020
What this trial tests

NA trial testing Mindfulness- Based Intervention in Psychological in 95 participants. Completed in 8 September 2018.

Timeline
23 January 2017
Primary endpoint
4 September 2018
8 September 2018

Quick facts

Lead sponsorBar-Ilan University, Israel
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposetreatment
Enrollment95
Start date23 January 2017
Primary completion4 September 2018
Estimated completion8 September 2018
Sites2 locations across Israel

Drugs / interventions tested

Conditions studied

Sponsor

Bar-Ilan University, Israel

Who can join

18 and older, any sex, with Psychological. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Fibromyalgia is a chronic pain syndrome, often involves high levels of depression, anxiety and cognitive deficits (e.g., "Fibro Fog"). 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 fibromyalgia 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. 95 Patients diagnosed with fibromyalgia (Mean age=52) were randomly assigned to either a 10-weeks MBI intervention (N=49) or a waitlist-control (WL;N=46). 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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Mindfulness-based stress reduction (MBSR) for fibromyalgia patients: The role of pain cognitions as mechanisms of change.
    Taub R, Agmon-Levin N, Frumer L, Samuel-Magal I, et al · · 2024 · cited 2× · PMID 38692113 · DOI 10.1016/j.ctcp.2024.101860
  2. Unraveling Chronic Pain: From Mechanisms and Risks to Diagnosis and Treatment.
    Dai X, Wang C, Jiang P, Mei X. · · 2026 · PMID 41930351 · DOI 10.1002/mco2.70685

Verify or expand the search:

Other trials of Mindfulness- Based Intervention

Trials testing the same drug.

Other recruiting trials for Psychological

Currently open trials in the same condition.

Other Bar-Ilan University, Israel trials

Trials by the same sponsor.

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