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Alexithymia Levels in Fibromyalgia

Investigation of Alexithymia Levels in Fibromyalgia Syndrome Before and After Treatment

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06841302
Enrollment
123
Registered
2025-02-24
Start date
2024-04-01
Completion date
2024-12-31
Last updated
2025-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alexithymia, Fibromyalgia (FM)

Keywords

Fibromyalgia, Alexithymia, aerobic exercise

Brief 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. 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.

Interventions

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.

Sponsors

Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* Meet the American College of Rheumatology's Fibromyalgia diagnostic criteria Have not received any previous psychiatric treatment

Exclusion criteria

* Presence of psychiatric disorders History of antidepressant use

Design outcomes

Primary

MeasureTime frameDescription
Alexithymia LevelFrom enrollment to the end of treatment at 6 monthsThe 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 scoreFrom enrollment to the end of treatment at 6 monthsChanges in participants' fibromyalgia symptom severity were measured with a Visual Analog Scale (VAS).
Correlations between baseline values and post-treatment changesFrom enrollment to the end of treatment at 6 monthsThe 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.

Secondary

MeasureTime frameDescription
Changes in TAS subscalesFrom enrollment to the end of treatment at 6 monthsChanges 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026