Fibromyalgia (FM)NCT06841302
Alexithymia Levels in Fibromyalgia
A study testing Fibromyalgia Agents in people with Fibromyalgia (FM) and Alexithymia, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The primary aim of this study was to investigate the changes in alexithymia levels in fibromyalgia patients over a six-month period following a combined treatment and to assess the relationship between changes in fibromyalgia symptom severity and changes in alexithymia levels. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Fibromyalgia (FM), Alexithymia
- What is being tested?
- Fibromyalgia Agents
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 123 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2024to 31 Dec 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
- Meet the American College of Rheumatology's Fibromyalgia diagnostic criteria Have not received any previous psychiatric treatment
Who cannot join
- Presence of psychiatric disorders History of antidepressant use
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
İstanbul Physical Medicine and Rehabilitation Hospital
Istanbul
About this study
Official title: Investigation of Alexithymia Levels in Fibromyalgia Syndrome Before and After Treatment
The primary aim of this study was to investigate the changes in alexithymia levels in fibromyalgia patients over a six-month period following a combined treatment and to assess the relationship between changes in fibromyalgia symptom severity and changes in alexithymia levels. Specifically, the study sought to determine if improvements in fibromyalgia symptoms, as measured by the Visual Analog Scale (VAS), were associated with reductions in alexithymia, as measured by the Toronto Alexithymia Scale-20 (TAS-20).
Read the detailed description
Background and Objectives: Fibromyalgia (FM) is a chronic pain condition characterized by widespread musculoskeletal pain, fatigue, sleep disturbances, and cognitive difficulties. FM affects approximately 0.2-6.6% of the world's population and is more frequent in women. It is known that psychiatric comorbidities are frequently observed in individuals with fibromyalgia (FM). In this context, while depression/major depressive disorder (MDD) stands out as the most commonly encountered psychiatric disorder among individuals diagnosed with FM, bipolar disorder, panic disorder, post-traumatic stress disorder (PTSD), and less frequently, anxiety disorders are also observed. The presence of these comorbidities can affect the clinical course and treatment response of FM, therefore, it is important to consider this condition in the evaluation of FM patients and in the development of treatment plans.
Alexithymia, characterized by difficulty identifying and describing feelings and a preference for external thinking, potentially leading individuals to report somatic symptoms like pain rather than emotional experiences. Alexithymia is more prevalent in individuals with fibromyalgia and it correlates with both distress and pain intensity. This study investigates whether successful SSRI treatment in fibromyalgia patients correlates with improved alexithymia levels, exploring the potential link between treatment response and enhanced emotional processing.
Methods:This prospective observational cohort study was conducted at Istanbul Physical Medicine and Rehabilitation Training and Research Hospital. Patients diagnosed with fibromyalgia syndrome (FMS) according to American College of Rheumatology criteria were included. Those with psychiatric disorders, neurological conditions causing alexithymia, or under antidepressant treatment were excluded. All participants received duloxetine treatment combined with an aerobic exercise program. Fibromyalgia symptoms were assessed using Visual Analog Scale (VAS) at baseline and 6 months, while alexithymia was evaluated using Toronto Alexithymia Scale-20 (TAS) at baseline, 3, and 6 months. Statistical analysis included repeated measures ANOVA with Greenhouse-Geisser correction, paired t-tests, and correlation analyses, with adjustments for age, BMI, and daily medication count.
- Conditions
- Fibromyalgia (FM), Alexithymia
- Being tested
- Fibromyalgia Agents
- Keywords
- Fibromyalgia, Alexithymia, aerobic exercise
- Medical subject headings
- Fibromyalgia, Affective Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fibromyalgia AgentsOther
All study participants were enrolled in a combined treatment program consisting of both a structured aerobic exercise program (swimming, cycling, or brisk walking for at least three days a week, with each session lasting two hours) and a pharmacological treatment regimen. Patients who did not adhere to the prescribed treatment regimen or who discontinued follow-up were excluded from the study.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Fibromyalgia | Experimental | This study group consisted of individuals diagnosed with fibromyalgia syndrome (FMS) according to the American College of Rheumatology criteria, who were also literate. The study specifically excluded individuals with pre-existing psychiatric disorders, neurological conditions known to cause alexithymia, or those currently undergoing antidepressant treatment. All study participants were enrolled in a combined treatment program consisting of both a structured aerobic exercise program (swimming, cycling, or brisk walking for at least three days a week, with each session lasting two hours) and a pharmacological treatment regimen. Patients who did not adhere to the prescribed treatment regimen or who discontinued follow-up were excluded from the study. Receives: Other: Fibromyalgia Agents |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alexithymia Level
The primary outcomes of this study are changes in alexithymia levels, measured by the Toronto Alexithymia Scale-20 (TAS-20), over the six-month period of treatment follow up.
Measured: From enrollment to the end of treatment at 6 months
VAS score
Changes in participants' fibromyalgia symptom severity were measured with a Visual Analog Scale (VAS).
Measured: From enrollment to the end of treatment at 6 months
Correlations between baseline values and post-treatment changes
The examination of associations between baseline Toronto Alexithymia Scale and Visual Analog Scale scores and posttreatment changes in these measures to investigate whether baseline symptom severity or alexithymia levels were predictive of treatment response.
Measured: From enrollment to the end of treatment at 6 months
Secondary outcomes (1)
Changes in TAS subscales
Changes in the individual subscales (e.g., Difficulty Identifying Feelings, Difficulty Describing Feelings, Externally-Oriented Thinking) could be considered secondary outcomes, providing a more granular understanding of how alexithymia is affected.
Measured: From enrollment to the end of treatment at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2025
- Study start1 Apr 2024
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Fibromyalgia (FM)Studies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Eser Kalaoglu, Istanbul Physical Medicine Rehabilitation Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06841302
- Sponsor's protocol ID
- IstPRMTRH-EK
- Status last verified
- Feb 2025
- First submitted
- 18 Feb 2025
- Last updated
- 24 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Martinez MP, Sanchez AI, Miro E, Lami MJ, Prados G, Morales A. Relationships between physical symptoms, emotional distress, and pain appraisal in fibromyalgia: the moderator effect of alexithymia. J Psychol. 2015 Jan-Apr;149(1-2):115-40. doi: 10.1080/00223980.2013.844673. Epub 2014 Mar 5.
PubMed 25511201Sfarlea A, Dehning S, Keller LK, Schulte-Korne G. Alexithymia predicts maladaptive but not adaptive emotion regulation strategies in adolescent girls with anorexia nervosa or depression. J Eat Disord. 2019 Nov 29;7:41. doi: 10.1186/s40337-019-0271-1. eCollection 2019.
PubMed 31798880Di Tella M, Castelli L. Alexithymia and fibromyalgia: clinical evidence. Front Psychol. 2013 Dec 2;4:909. doi: 10.3389/fpsyg.2013.00909. eCollection 2013.
PubMed 24348453Kleykamp BA, Ferguson MC, McNicol E, Bixho I, Arnold LM, Edwards RR, Fillingim R, Grol-Prokopczyk H, Turk DC, Dworkin RH. The Prevalence of Psychiatric and Chronic Pain Comorbidities in Fibromyalgia: an ACTTION systematic review. Semin Arthritis Rheum. 2021 Feb;51(1):166-174. doi: 10.1016/j.semarthrit.2020.10.006. Epub 2020 Dec 29.
PubMed 33383293Habibi Asgarabad M, Salehi Yegaei P, Jafari F, Azami-Aghdash S, Lumley MA. The relationship of alexithymia to pain and other symptoms in fibromyalgia: A systematic review and meta-analysis. Eur J Pain. 2023 Mar;27(3):321-337. doi: 10.1002/ejp.2064. Epub 2022 Dec 20.
PubMed 36471652Atasoy M, Kalaoglu E, Takim U, Gokcay H. Investigation of alexithymia levels in fibromyalgia before and after treatment. Clin Exp Rheumatol. 2026 Jan;44(1):130-137. doi: 10.55563/clinexprheumatol/45nmy7. Epub 2025 Oct 3.
PubMed 41042725
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Alexithymia Levels in Fibromyalgia Syndrome Before and After Treatment
- ClinicalTrials.gov ID
- NCT06841302
- Acronym / sponsor ID
- IstPRMTRH-EK
- Conditions
- Fibromyalgia (FM), Alexithymia
- Keywords
- Fibromyalgia, Alexithymia, aerobic exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research HospitalOther government
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 24 Feb 2025 (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.
The primary aim of this study was to investigate the changes in alexithymia levels in fibromyalgia patients over a six-month period following a combined treatment and to assess the relationship between changes in fibromyalgia symptom severity and changes in alexithymia levels. Specifically, the study sought to determine if improvements in fibromyalgia symptoms, as measured by the Visual Analog Scale (VAS), were associated with reductions in alexithymia, as measured by the Toronto Alexithymia Scale-20 (TAS-20).
Detailed description
Background and Objectives: Fibromyalgia (FM) is a chronic pain condition characterized by widespread musculoskeletal pain, fatigue, sleep disturbances, and cognitive difficulties. FM affects approximately 0.2-6.6% of the world's population and is more frequent in women. It is known that psychiatric comorbidities are frequently observed in individuals with fibromyalgia (FM). In this context, while depression/major depressive disorder (MDD) stands out as the most commonly encountered psychiatric disorder among individuals diagnosed with FM, bipolar disorder, panic disorder, post-traumatic stress disorder (PTSD), and less frequently, anxiety disorders are also observed. The presence of these comorbidities can affect the clinical course and treatment response of FM, therefore, it is important to consider this condition in the evaluation of FM patients and in the development of treatment plans.
Alexithymia, characterized by difficulty identifying and describing feelings and a preference for external thinking, potentially leading individuals to report somatic symptoms like pain rather than emotional experiences. Alexithymia is more prevalent in individuals with fibromyalgia and it correlates with both distress and pain intensity. This study investigates whether successful SSRI treatment in fibromyalgia patients correlates with improved alexithymia levels, exploring the potential link between treatment response and enhanced emotional processing.
Methods:This prospective observational cohort study was conducted at Istanbul Physical Medicine and Rehabilitation Training and Research Hospital. Patients diagnosed with fibromyalgia syndrome (FMS) according to American College of Rheumatology criteria were included. Those with psychiatric disorders, neurological conditions causing alexithymia, or under antidepressant treatment were excluded. All participants received duloxetine treatment combined with an aerobic exercise program. Fibromyalgia symptoms were assessed using Visual Analog Scale (VAS) at baseline and 6 months, while alexithymia was evaluated using Toronto Alexithymia Scale-20 (TAS) at baseline, 3, and 6 months. Statistical analysis included repeated measures ANOVA with Greenhouse-Geisser correction, paired t-tests, and correlation analyses, with adjustments for age, BMI, and daily medication count.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Fibromyalgia | Experimental | Other: Fibromyalgia AgentsThis study group consisted of individuals diagnosed with fibromyalgia syndrome (FMS) according to the American College of Rheumatology criteria, who were also literate. The study specifically excluded individuals with pre-existing psychiatric disorders, neurological conditions known to cause alexithymia, or those currently undergoing antidepressant treatment. All study participants were enrolled in a combined treatment program consisting of both a structured aerobic exercise program (swimming, cycling, or brisk walking for at least three days a week, with each session lasting two hours) and a pharmacological treatment regimen. Patients who did not adhere to the prescribed treatment regimen or who discontinued follow-up were excluded from the study. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Meet the American College of Rheumatology's Fibromyalgia diagnostic criteria Have not received any previous psychiatric treatment
Key exclusion criteria (1 listed)
- Presence of psychiatric disorders History of antidepressant use
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 |
|---|---|---|
| Fibromyalgia AgentsAll study participants were enrolled in a combined treatment program consisting of both a structured aerobic exercise program (swimming, cycling, or brisk walking for at least three days a week, with each session lasting two hours) and a pharmacological treatment regimen. Patients who did not adhere to the prescribed treatment regimen or who discontinued follow-up were excluded from the study. | Other | Patients with Fibromyalgia |
Primary outcome
Alexithymia Level
Time frame: From enrollment to the end of treatment at 6 months
The primary outcomes of this study are changes in alexithymia levels, measured by the Toronto Alexithymia Scale-20 (TAS-20), over the six-month period of treatment follow up.
VAS score
Time frame: From enrollment to the end of treatment at 6 months
Changes in participants' fibromyalgia symptom severity were measured with a Visual Analog Scale (VAS).
Correlations between baseline values and post-treatment changes
Time frame: From enrollment to the end of treatment at 6 months
The examination of associations between baseline Toronto Alexithymia Scale and Visual Analog Scale scores and posttreatment changes in these measures to investigate whether baseline symptom severity or alexithymia levels were predictive of treatment response.
1 secondary outcome
Changes in TAS subscales
Time frame: From enrollment to the end of treatment at 6 months
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 24 Feb 2025.
- Background: PubMed 25511201Martinez MP, Sanchez AI, Miro E, Lami MJ, Prados G, Morales A. Relationships between physical symptoms, emotional distress, and pain appraisal in fibromyalgia: the moderator effect of alexithymia. J Psychol. 2015 Jan-Apr;149(1-2):115-40. doi: 10.1080/00223980.2013.844673. Epub 2014 Mar 5.
- Background: PubMed 31798880Sfarlea A, Dehning S, Keller LK, Schulte-Korne G. Alexithymia predicts maladaptive but not adaptive emotion regulation strategies in adolescent girls with anorexia nervosa or depression. J Eat Disord. 2019 Nov 29;7:41. doi: 10.1186/s40337-019-0271-1. eCollection 2019.
- Background: PubMed 24348453Di Tella M, Castelli L. Alexithymia and fibromyalgia: clinical evidence. Front Psychol. 2013 Dec 2;4:909. doi: 10.3389/fpsyg.2013.00909. eCollection 2013.
- Background: PubMed 33383293Kleykamp BA, Ferguson MC, McNicol E, Bixho I, Arnold LM, Edwards RR, Fillingim R, Grol-Prokopczyk H, Turk DC, Dworkin RH. The Prevalence of Psychiatric and Chronic Pain Comorbidities in Fibromyalgia: an ACTTION systematic review. Semin Arthritis Rheum. 2021 Feb;51(1):166-174. doi: 10.1016/j.semarthrit.2020.10.006. Epub 2020 Dec 29.
- Background: PubMed 36471652Habibi Asgarabad M, Salehi Yegaei P, Jafari F, Azami-Aghdash S, Lumley MA. The relationship of alexithymia to pain and other symptoms in fibromyalgia: A systematic review and meta-analysis. Eur J Pain. 2023 Mar;27(3):321-337. doi: 10.1002/ejp.2064. Epub 2022 Dec 20.
- Derived from this study: PubMed 41042725Atasoy M, Kalaoglu E, Takim U, Gokcay H. Investigation of alexithymia levels in fibromyalgia before and after treatment. Clin Exp Rheumatol. 2026 Jan;44(1):130-137. doi: 10.55563/clinexprheumatol/45nmy7. Epub 2025 Oct 3.
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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 Fibromyalgia Agents in people with Fibromyalgia (FM) and Alexithymia, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital 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 1 inclusion and 1 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 24 Feb 2025. 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?
Alexithymia Level (time frame: From enrollment to the end of treatment at 6 months). The study lists 3 primary outcomes in all. 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 NCT06841302, which also lists 6 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 24 Feb 2025.