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

February 8, 2026 updated by: Sena Çağlayan, Gazi University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

94

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Ankara
      • Ankara, Ankara, Turkey (Türkiye), 06500
        • Gazi University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Online MBSR
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)
An 8-week online mindfulness-based stress reduction program consisting of weekly group sessions delivered via videoconferencing and guided mindfulness practices.
No Intervention: Waitlist Control (Treatment as Usual)
Participants received treatment as usual and did not receive any additional psychological intervention during the study period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fibromyalgia Impact Questionnaire (FIQ) Total Score
Time Frame: 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.
Baseline and after 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gazi University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2024

Primary Completion (Actual)

June 28, 2024

Study Completion (Actual)

June 28, 2024

Study Registration Dates

First Submitted

February 8, 2026

First Submitted That Met QC Criteria

February 8, 2026

First Posted (Actual)

February 13, 2026

Study Record Updates

Last Update Posted (Actual)

February 13, 2026

Last Update Submitted That Met QC Criteria

February 8, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GAZI-ONLINE-MBSR-FMS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared due to ethical and privacy considerations, as data sharing was not included in the informed consent and ethics committee approval.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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