Alexithymia Levels in Fibromyalgia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

123 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-01

Study Completion Date

2024-12-31

Brief Summary

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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).

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Detailed Description

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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

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Fibromyalgia (FM) Alexithymia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Patients with Fibromyalgia

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.

Group Type EXPERIMENTAL

Fibromyalgia Agents

Intervention Type OTHER

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.

Interventions

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Fibromyalgia Agents

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.

Intervention Type OTHER