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

NCT07410572 | Completed

• 1 other identifier: GAZI-ONLINE-MBSR-FMS
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Fibromyalgia Syndrome

Keywords

Fibromyalgia; Mindfulness-Based Stress Reduction; Online Intervention; Somatosensory Temporal Discrimination; Pain Catastrophizing

Outcome Measures

Primary Outcomes (1)

• Fibromyalgia Impact Questionnaire (FIQ) Total Score

  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.

  Baseline and after 8 weeks

Study Arms (2)

Online MBSR

EXPERIMENTAL

Participants received an 8-week online mindfulness-based stress reduction program delivered via videoconferencing in addition to treatment as usual.

Behavioral: Online Mindfulness-Based Stress Reduction (MBSR)

Waitlist Control (Treatment as Usual)

NO INTERVENTION

Participants received treatment as usual and did not receive any additional psychological intervention during the study period.

Interventions

Online Mindfulness-Based Stress Reduction (MBSR) BEHAVIORAL

An 8-week online mindfulness-based stress reduction program consisting of weekly group sessions delivered via videoconferencing and guided mindfulness practices.

Online MBSR

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gazi University: lead

Study Sites (1)

Gazi University Hospital

Ankara, Ankara, 06500, Turkey (Türkiye)

Location

Related Publications (2)

• Andres-Rodriguez L, Borras X, Feliu-Soler A, Perez-Aranda A, Rozadilla-Sacanell A, Montero-Marin J, Maes M, Luciano JV. Immune-inflammatory pathways and clinical changes in fibromyalgia patients treated with Mindfulness-Based Stress Reduction (MBSR): A randomized, controlled clinical trial. Brain Behav Immun. 2019 Aug;80:109-119. doi: 10.1016/j.bbi.2019.02.030. Epub 2019 Feb 25.

  PMID: 30818032 BACKGROUND

• Kabat-Zinn J. An outpatient program in behavioral medicine for chronic pain patients based on the practice of mindfulness meditation: theoretical considerations and preliminary results. Gen Hosp Psychiatry. 1982 Apr;4(1):33-47. doi: 10.1016/0163-8343(82)90026-3.

  PMID: 7042457 BACKGROUND

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The study was conducted as an open-label trial. However, somatosensory temporal discrimination assessments were performed by assessors who were blinded to group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants were randomly assigned in parallel to either an online mindfulness-based stress reduction intervention group or a waitlist control group receiving treatment as usual.

Study Record Dates

• First Submitted: February 8, 2026
• First Posted: February 13, 2026
• Study Start: January 1, 2024
• Primary Completion: June 28, 2024
• Study Completion: June 28, 2024
• Last Updated: February 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)