NCT07410572

Effectiveness of an Online Mindfulness-Based Stress Reduction Program in Patients With Fibromyalgia Syndrome

Effects of an 8-Week Online Mindfulness-Based Stress Reduction Program on Pain Catastrophizing, Functionality, and Clinical Outcomes in Patients With Fibromyalgia Syndrome: A Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 94 (actual)
• Sponsor: Gazi University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Fibromyalgia syndrome (FMS) is a chronic disorder characterized by widespread musculoskeletal pain, fatigue, sleep disturbances, functional limitations, and psychological symptoms. In addition to clinical symptoms, alterations in somatosensory processing, such as impaired somatosensory temporal discrimination, have been reported in patients with FMS. Although pharmacological treatments are commonly used, they are often insufficient to address the multidimensional nature of the condition, and non-pharmacological, multidisciplinary interventions are increasingly recommended. Mindfulness-based stress reduction (MBSR) is a structured program originally developed for individuals with chronic pain, aiming to improve awareness of bodily sensations, emotions, and thoughts through mindfulness practices. While previous studies have investigated the effects of face-to-face MBSR in patients with FMS, evidence regarding the effectiveness of online delivery formats remains limited. This study was designed as a parallel-group, randomized controlled trial to assess the effects of an 8-week online MBSR program in patients diagnosed with fibromyalgia syndrome. A total of 94 participants aged between 18 and 65 years were recruited and randomly assigned in equal numbers to either an online MBSR intervention group or a waitlist control group. Participants in both groups continued their usual pharmacological and/or non-pharmacological treatments throughout the study period. The online MBSR intervention consisted of weekly group sessions delivered via videoconferencing and included guided mindfulness practices, body awareness exercises, and psychoeducation. The control group did not receive any additional psychological intervention during the study period. Outcome measures were assessed at baseline and after the completion of the intervention period. Clinical outcomes included pain severity, functionality, psychological symptoms, pain catastrophizing, and mindfulness levels, which were evaluated using validated self-report instruments. Somatosensory temporal discrimination thresholds were assessed using a standard electrophysiological device routinely used for clinical neurophysiological testing. Randomization procedures and somatosensory assessments were conducted in a blinded manner. This study evaluates the effects of an 8-week online mindfulness-based stress reduction program, as an adjunct to usual care, on clinical outcomes and somatosensory temporal discrimination thresholds in patients with fibromyalgia syndrome.

Conditions

• Fibromyalgia Syndrome

Interventions

Type	Name	Description
BEHAVIORAL	Online Mindfulness-Based Stress Reduction (MBSR)	An 8-week online mindfulness-based stress reduction program consisting of weekly group sessions delivered via videoconferencing and guided mindfulness practices.

Timeline

• Start date: 2024-01-01
• Primary completion: 2024-06-28
• Completion: 2024-06-28
• First posted: 2026-02-13
• Last updated: 2026-02-13

Locations

1 site across 1 country: Turkey (Türkiye)