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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 94
- 试验地点
- 1
- 主要终点
- Fibromyalgia Impact Questionnaire (FIQ) Total Score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
The study was conducted as an open-label trial. However, somatosensory temporal discrimination assessments were performed by assessors who were blinded to group allocation.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Online MBSR
Participants received an 8-week online mindfulness-based stress reduction program delivered via videoconferencing in addition to treatment as usual.
干预措施: Online Mindfulness-Based Stress Reduction (MBSR) (Behavioral)
Waitlist Control (Treatment as Usual)
Participants received treatment as usual and did not receive any additional psychological intervention during the study period.
结局指标
主要结局
Fibromyalgia Impact Questionnaire (FIQ) Total Score
时间窗: Baseline and after 8 weeks
Functionality and fibromyalgia-related health status were assessed using the Fibromyalgia Impact Questionnaire (FIQ), with higher scores indicating greater impact/impairment. The validated Turkish version of the questionnaire was used.
次要结局
未报告次要终点
研究者
Sena Çağlayan
Principal Investigator
Gazi University