FibromyalgiaNCT07904468
Daily Cognitive Failures and Medication Adherence in Fibromyalgia
An observational study of Fibromyalgia, run by Mardin Artuklu University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to investigate the relationship between everyday cognitive failures and medication adherence in adults with fibromyalgia. Fibromyalgia is a chronic condition associated with widespread pain, fatigue, and cognitive difficulties such as forgetfulness and problems with attention. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Fibromyalgia
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Dec 2026to 15 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: The study population will consist of 70 adults aged 18-65 years diagnosed with fibromyalgia according to the 2016 ACR criteria and regularly taking at least one medication for fibromyalgia. Participants will be recruited from the Physical Medicine and Rehabilitation Outpatient Clinic of Mardin Training and Research Hospital, Türkiye. Eligible patients who provide written informed consent will undergo a single-visit assessment of everyday cognitive failures, medication adherence, anxiety and depressive symptoms, pain severity, and medication use.
Who may be able to join
- Adults aged 18-65 years.
- Diagnosis of fibromyalgia according to the 2016 American College of Rheumatology (ACR) criteria.
- Regular use of at least one medication for fibromyalgia.
- Willingness to participate in the study and provision of written informed consent.
Who cannot join
- Cognitive impairment severe enough to prevent reliable completion of the assessment questionnaires.
- Active psychotic disorder or severe psychiatric illness that significantly interferes with participation in the assessment.
- Pregnancy, postpartum period, or breastfeeding.
- Communication difficulties that prevent understanding or answering the study questionnaires.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Mardin Training and Research Hospital
Mardin, 47100
Taha Y Yıldırım, M.D., +90 534 220 77 17, tyasinyildirim.ftr@gmail.com
About this study
Official title: Daily Cognitive Failures and Medication Adherence in Fibromyalgia: A Cross-Sectional Study
This study aims to investigate the relationship between everyday cognitive failures and medication adherence in adults with fibromyalgia.
Fibromyalgia is a chronic condition associated with widespread pain, fatigue, and cognitive difficulties such as forgetfulness and problems with attention. These difficulties may affect patients' ability to take prescribed medications regularly, but their relationship with medication adherence remains unclear.
Read more
This single-center, observational, cross-sectional study will include 70 adults aged 18-65 years diagnosed with fibromyalgia who regularly take at least one medication for the condition.
Everyday cognitive failures will be assessed using the Cognitive Failures Questionnaire (CFQ), and medication adherence will be assessed using the five-item Medication Adherence Report Scale (MARS-5). Anxiety and depressive symptoms will be evaluated using the Hospital Anxiety and Depression Scale (HADS). Information on pain severity, medications, and daily medication-taking frequency will also be collected.
The study will examine whether greater cognitive failures are associated with lower medication adherence and whether this relationship remains after accounting for anxiety, depressive symptoms, number of regularly used medications, and daily medication-taking frequency.
All assessments will be completed during a single visit lasting approximately 12-15 minutes. No experimental treatments, additional laboratory tests, or invasive procedures will be performed.
Read the detailed description
Cognitive difficulties are frequently reported by individuals with fibromyalgia and may involve attention, memory, and everyday cognitive functioning. Although cognitive impairment and medication adherence have been investigated separately in fibromyalgia, the relationship between everyday cognitive failures and adherence to prescribed medication remains insufficiently understood.
The primary objective of this study is to evaluate the association between everyday cognitive failures, measured by the Cognitive Failures Questionnaire (CFQ), and medication adherence, measured by the five-item Medication Adherence Report Scale (MARS-5).
The MARS-5 total score will serve as the primary outcome variable, while the CFQ total score will be the main explanatory variable. Higher MARS-5 scores indicate better medication adherence, whereas higher CFQ scores indicate more frequent everyday cognitive failures. For participants using multiple medications for fibromyalgia, adherence will be assessed for the medication used regularly for the longest duration.
The relationship between CFQ and MARS-5 total scores will be examined using Pearson or Spearman correlation analysis, depending on the distribution of the data.
A multivariable linear regression model will additionally be used to assess whether cognitive failures are independently associated with medication adherence after adjustment for anxiety symptoms, depressive symptoms, the number of regularly used medications, and daily medication-taking frequency.
Exploratory analyses will investigate the associations of age, sex, educational level, duration of fibromyalgia, and pain severity with CFQ and MARS-5 scores.
The study will be conducted at the Physical Medicine and Rehabilitation Outpatient Clinic of Mardin Training and Research Hospital, Türkiye. Participants will complete all assessments during a single visit without any additional medical intervention.
As this is a cross-sectional study, the findings will be interpreted as associations and will not establish causal relationships.
- Conditions
- Fibromyalgia
- Keywords
- Fibromyalgia, Cognitive Failures Questionnaire (CFQ), Medication Adherence Report Scale (MARS-5), Hospital Anxiety and Depression Scale (HADS), Medication Adherence
- Medical subject headings
- Fibromyalgia, Depression, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Fibromyalgia Group | Adults aged 18-65 years diagnosed with fibromyalgia according to the 2016 American College of Rheumatology (ACR) criteria and regularly taking at least one medication for fibromyalgia. Participants will undergo a single-visit assessment using the Cognitive Failures Questionnaire (CFQ), Medication Adherence Report Scale (MARS-5), and Hospital Anxiety and Depression Scale (HADS). Demographic characteristics, pain severity, and medication use will also be recorded. No experimental interventions or additional medical procedures will be performed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication Adherence Assessed by MARS-5 in Relation to Pain Severity
Medication adherence will be measured using the five-item Medication Adherence Report Scale (MARS-5). Total scores range from 5 to 25, with higher scores indicating better medication adherence. The association between MARS-5 total scores and pain severity, assessed using the Numeric Rating Scale (NRS; 0-10), will be examined as an exploratory analysis. MARS-5 will be the outcome variable, and pain severity will be the explanatory variable.
Measured: Baseline
Secondary outcomes (2)
Everyday Cognitive Failures Assessed by the Cognitive Failures Questionnaire (CFQ)
Everyday cognitive failures will be assessed using the 25-item Cognitive Failures Questionnaire (CFQ). Each item is scored from 0 to 3, yielding a total score ranging from 0 to 75. Higher scores indicate more frequent everyday cognitive failures, whereas lower scores indicate fewer cognitive failures.
Measured: Baseline
Anxiety Symptoms Assessed by the Hospital Anxiety and Depression Scale (HADS-A)
Anxiety symptoms will be assessed using the seven-item anxiety subscale of the Hospital Anxiety and Depression Scale (HADS-A). Each item is scored from 0 to 3, yielding a total score ranging from 0 to 21. Higher scores indicate more severe anxiety symptoms, whereas lower scores indicate fewer anxiety symptoms.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2026
- Study start15 Dec 2026 (estimated)
- Primary completion15 Nov 2027 (estimated)
- Study completion15 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mardin Artuklu University
- Sponsor type
- University, hospital or other
- Collaborators
- Mardin Training and Research Hospital
- Responsible party
- Principal investigator, Taha Yasin YILDIRIM, Mardin Artuklu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07904468
- Sponsor's protocol ID
- MEAH-PMR-TYY6
- Status last verified
- Oct 2026
- First submitted
- 12 Oct 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Prikhodkina M, Melnikov S. Factors that influence medication adherence in women with fibromyalgia: A path analysis. J Clin Nurs. 2024 Oct;33(10):3943-3953. doi: 10.1111/jocn.17044. Epub 2024 Jan 29.
PubMed 38284436Ben-Ami Shor D, Weitzman D, Dahan S, Gendelman O, Bar-On Y, Amital D, Shalev V, Chodick G, Amital H. Adherence and Persistence with Drug Therapy among Fibromyalgia Patients: Data from a Large Health Maintenance Organization. J Rheumatol. 2017 Oct;44(10):1499-1506. doi: 10.3899/jrheum.170098. Epub 2017 Aug 1.
PubMed 28765248Wu YL, Huang CJ, Fang SC, Ko LH, Tsai PS. Cognitive Impairment in Fibromyalgia: A Meta-Analysis of Case-Control Studies. Psychosom Med. 2018 Jun;80(5):432-438. doi: 10.1097/PSY.0000000000000575.
PubMed 29528888
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Daily Cognitive Failures and Medication Adherence in Fibromyalgia: A Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT07904468
- Acronym / sponsor ID
- MEAH-PMR-TYY6
- Conditions
- Fibromyalgia
- Keywords
- Fibromyalgia, Cognitive Failures Questionnaire (CFQ), Medication Adherence Report Scale (MARS-5), Hospital Anxiety and Depression Scale (HADS), Medication Adherence
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Mardin Artuklu UniversityUniversity, hospital or other
- Collaborators
- Mardin Training and Research Hospital
- Study start
- 15 Dec 2026 (estimated)
- Primary completion
- 15 Nov 2027 (estimated)
- Study completion
- 15 Dec 2027 (estimated)
- First posted
- 29 Oct 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.
This study aims to investigate the relationship between everyday cognitive failures and medication adherence in adults with fibromyalgia.
Fibromyalgia is a chronic condition associated with widespread pain, fatigue, and cognitive difficulties such as forgetfulness and problems with attention. These difficulties may affect patients' ability to take prescribed medications regularly, but their relationship with medication adherence remains unclear.
This single-center, observational, cross-sectional study will include 70 adults aged 18-65 years diagnosed with fibromyalgia who regularly take at least one medication for the condition.
Everyday cognitive failures will be assessed using the Cognitive Failures Questionnaire (CFQ), and medication adherence will be assessed using the five-item Medication Adherence Report Scale (MARS-5). Anxiety and depressive symptoms will be evaluated using the Hospital Anxiety and Depression Scale (HADS). Information on pain severity, medications, and daily medication-taking frequency will also be collected.
The study will examine whether greater cognitive failures are associated with lower medication adherence and whether this relationship remains after accounting for anxiety, depressive symptoms, number of regularly used medications, and daily medication-taking frequency.
All assessments will be completed during a single visit lasting approximately 12-15 minutes. No experimental treatments, additional laboratory tests, or invasive procedures will be performed.
Detailed description
Cognitive difficulties are frequently reported by individuals with fibromyalgia and may involve attention, memory, and everyday cognitive functioning. Although cognitive impairment and medication adherence have been investigated separately in fibromyalgia, the relationship between everyday cognitive failures and adherence to prescribed medication remains insufficiently understood.
The primary objective of this study is to evaluate the association between everyday cognitive failures, measured by the Cognitive Failures Questionnaire (CFQ), and medication adherence, measured by the five-item Medication Adherence Report Scale (MARS-5).
The MARS-5 total score will serve as the primary outcome variable, while the CFQ total score will be the main explanatory variable. Higher MARS-5 scores indicate better medication adherence, whereas higher CFQ scores indicate more frequent everyday cognitive failures. For participants using multiple medications for fibromyalgia, adherence will be assessed for the medication used regularly for the longest duration.
The relationship between CFQ and MARS-5 total scores will be examined using Pearson or Spearman correlation analysis, depending on the distribution of the data.
A multivariable linear regression model will additionally be used to assess whether cognitive failures are independently associated with medication adherence after adjustment for anxiety symptoms, depressive symptoms, the number of regularly used medications, and daily medication-taking frequency.
Exploratory analyses will investigate the associations of age, sex, educational level, duration of fibromyalgia, and pain severity with CFQ and MARS-5 scores.
The study will be conducted at the Physical Medicine and Rehabilitation Outpatient Clinic of Mardin Training and Research Hospital, Türkiye. Participants will complete all assessments during a single visit without any additional medical intervention.
As this is a cross-sectional study, the findings will be interpreted as associations and will not establish causal relationships.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fibromyalgia Group | – | –Adults aged 18-65 years diagnosed with fibromyalgia according to the 2016 American College of Rheumatology (ACR) criteria and regularly taking at least one medication for fibromyalgia. Participants will undergo a single-visit assessment using the Cognitive Failures Questionnaire (CFQ), Medication Adherence Report Scale (MARS-5), and Hospital Anxiety and Depression Scale (HADS). Demographic characteristics, pain severity, and medication use will also be recorded. No experimental interventions or additional medical procedures will be performed. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of 70 adults aged 18-65 years diagnosed with fibromyalgia according to the 2016 ACR criteria and regularly taking at least one medication for fibromyalgia. Participants will be recruited from the Physical Medicine and Rehabilitation Outpatient Clinic of Mardin Training and Research Hospital, Türkiye. Eligible patients who provide written informed consent will undergo a single-visit assessment of everyday cognitive failures, medication adherence, anxiety and depressive symptoms, pain severity, and medication use.
Key inclusion criteria (4 listed)
- Adults aged 18-65 years.
- Diagnosis of fibromyalgia according to the 2016 American College of Rheumatology (ACR) criteria.
- Regular use of at least one medication for fibromyalgia.
- Willingness to participate in the study and provision of written informed consent.
Key exclusion criteria (4 listed)
- Cognitive impairment severe enough to prevent reliable completion of the assessment questionnaires.
- Active psychotic disorder or severe psychiatric illness that significantly interferes with participation in the assessment.
- Pregnancy, postpartum period, or breastfeeding.
- Communication difficulties that prevent understanding or answering the study questionnaires.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Medication Adherence Assessed by MARS-5 in Relation to Pain Severity
Time frame: Baseline
Medication adherence will be measured using the five-item Medication Adherence Report Scale (MARS-5). Total scores range from 5 to 25, with higher scores indicating better medication adherence. The association between MARS-5 total scores and pain severity, assessed using the Numeric Rating Scale (NRS; 0-10), will be examined as an exploratory analysis. MARS-5 will be the outcome variable, and pain severity will be the explanatory variable.
2 secondary outcomes
Everyday Cognitive Failures Assessed by the Cognitive Failures Questionnaire (CFQ)
Time frame: Baseline
Anxiety Symptoms Assessed by the Hospital Anxiety and Depression Scale (HADS-A)
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Background: PubMed 38284436Prikhodkina M, Melnikov S. Factors that influence medication adherence in women with fibromyalgia: A path analysis. J Clin Nurs. 2024 Oct;33(10):3943-3953. doi: 10.1111/jocn.17044. Epub 2024 Jan 29.
- Background: PubMed 28765248Ben-Ami Shor D, Weitzman D, Dahan S, Gendelman O, Bar-On Y, Amital D, Shalev V, Chodick G, Amital H. Adherence and Persistence with Drug Therapy among Fibromyalgia Patients: Data from a Large Health Maintenance Organization. J Rheumatol. 2017 Oct;44(10):1499-1506. doi: 10.3899/jrheum.170098. Epub 2017 Aug 1.
- Background: PubMed 29528888Wu YL, Huang CJ, Fang SC, Ko LH, Tsai PS. Cognitive Impairment in Fibromyalgia: A Meta-Analysis of Case-Control Studies. Psychosom Med. 2018 Jun;80(5):432-438. doi: 10.1097/PSY.0000000000000575.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fibromyalgia, run by Mardin Artuklu 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 4 inclusion and 4 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: opening soon, as of the sponsor's last update on 29 Oct 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Taha Y Yıldırım, M.D. (+90 534 220 77 17, tyasinyildirim.ftr@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medication Adherence Assessed by MARS-5 in Relation to Pain Severity (time frame: Baseline). 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 NCT07904468, which also lists 3 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 29 Oct 2026.