Effectiveness of an Online Mindfulness-Based Stress Reduction Program in Patients With Fibromyalg… (NCT07410572) | Clinical Trial Compass
CompletedNot Applicable
Effectiveness of an Online Mindfulness-Based Stress Reduction Program in Patients With Fibromyalgia Syndrome
Turkey (Türkiye)94 participantsStarted 2024-01-01
Plain-language summary
Fibromyalgia syndrome (FMS) is a chronic condition characterized by widespread pain, fatigue, sleep disturbances, functional impairment, and psychological symptoms. Pharmacological treatments alone are often insufficient, and multidisciplinary, non-pharmacological approaches are recommended for the management of FMS. Mindfulness-based stress reduction (MBSR) has been developed for individuals with chronic pain, and studies investigating its effectiveness in patients with FMS are increasing. However, evidence regarding online delivery of MBSR remains limited.
This parallel-group, randomized controlled trial aims to investigate the effects of an 8-week online mindfulness-based stress reduction (MBSR) program on mindfulness levels, pain severity, functionality, pain catastrophizing, and somatosensory temporal discrimination ability in patients with fibromyalgia syndrome. A total of 94 participants aged 18 to 65 years and diagnosed with FMS were randomly assigned to either an online MBSR intervention group or a waitlist control group receiving treatment as usual.
Outcome measures were assessed at baseline and after the intervention period using validated self-report scales and somatosensory temporal discrimination threshold measurements. By evaluating both clinical outcomes and somatosensory processing, this study aims to contribute to the understanding of the potential role of online mindfulness-based interventions as an accessible and complementary treatment option for patients with fibromyalgia syndrome.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adults aged 18 to 65 years
* Willingness to participate in the study and provision of written informed consent
* Completion of at least 8 years of compulsory education
* Montreal Cognitive Assessment (MoCA) score ≥ 21
* Diagnosis of fibromyalgia syndrome according to the 2016 American College of Rheumatology (ACR) criteria
* Pain severity of ≥ 4 cm on the Visual Analog Scale (VAS) during the previous 7 days
Exclusion Criteria:
* Age below 18 years or above 65 years
* Refusal to participate in the study
* Completion of less than 8 years of compulsory education
* MoCA score \< 21
* Absence of fibromyalgia diagnosis according to the 2016 ACR criteria
* Pain severity of \< 4 cm on the Visual Analog Scale (VAS) during the previous 7 days
* History of migraine or any peripheral or central neurological disorder
* History of inflammatory rheumatic diseases
* History of malignancy
* Pregnancy or lactation
* Presence of conditions associated with significant cognitive impairment (e.g., dementia, amnestic disorders, intellectual disability)
* Presence of bipolar disorder, psychotic disorders, severe depressive disorder, alcohol or substance use disorder, or active suicidal ideation
* Previous participation in any mindfulness-based intervention or training program
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Fibromyalgia Impact Questionnaire (FIQ) Total Score