Fibromyalgia SyndromeNCT07410572
Effectiveness of an Online Mindfulness-Based Stress Reduction Program in Patients With Fibromyalgia Syndrome
A study testing Online Mindfulness-Based Stress Reduction (MBSR) in people with Fibromyalgia Syndrome, run by Gazi University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Fibromyalgia Syndrome
- What is being tested?
- Online Mindfulness-Based Stress Reduction (MBSR)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2024to 28 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gazi University Hospital
Ankara, Ankara, 06500
About this study
Official title: 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.
Read the 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
- Being tested
- Online Mindfulness-Based Stress Reduction (MBSR)
- Keywords
- Fibromyalgia, Mindfulness-Based Stress Reduction, Online Intervention, Somatosensory Temporal Discrimination, Pain Catastrophizing
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online Mindfulness-Based Stress Reduction (MBSR)Behavioural
An 8-week online mindfulness-based stress reduction program consisting of weekly group sessions delivered via videoconferencing and guided mindfulness practices.
| Study group | Role | What they receive |
|---|---|---|
| Online MBSR | Experimental | Participants received an 8-week online mindfulness-based stress reduction program delivered via videoconferencing in addition to treatment as usual. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and after 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2026
- Study start1 Jan 2024
- Primary completion28 Jun 2024
- Study completion28 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Fibromyalgia SyndromeStudies of the same condition, open and under way.
- More trials run by Gazi UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sena Çağlayan, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07410572
- Sponsor's protocol ID
- GAZI-ONLINE-MBSR-FMS
- Status last verified
- Feb 2026
- First submitted
- 8 Feb 2026
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 30818032Kabat-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.
PubMed 7042457
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07410572
- Acronym / sponsor ID
- GAZI-ONLINE-MBSR-FMS
- Conditions
- Fibromyalgia Syndrome
- Keywords
- Fibromyalgia, Mindfulness-Based Stress Reduction, Online Intervention, Somatosensory Temporal Discrimination, Pain Catastrophizing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 28 Jun 2024 (actual)
- Study completion
- 28 Jun 2024 (actual)
- First posted
- 13 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Online MBSR | Experimental | Behavioral: Online Mindfulness-Based Stress Reduction (MBSR)Participants received an 8-week online mindfulness-based stress reduction program delivered via videoconferencing in addition to treatment as usual. |
| Waitlist Control (Treatment as Usual) | No intervention | –Participants received treatment as usual and did not receive any additional psychological intervention during the study period. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Online MBSR |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
- Background: PubMed 30818032Andres-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.
- Background: PubMed 7042457Kabat-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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online Mindfulness-Based Stress Reduction (MBSR) in people with Fibromyalgia Syndrome, run by Gazi University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fibromyalgia Impact Questionnaire (FIQ) Total Score (time frame: Baseline and after 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07410572, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2026.