Skip to main content
OpenTrials
Completed

NCT Number: NCT06841302

Alexithymia Levels in Fibromyalgia

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Fibromyalgia (FM) Affective Symptoms Alexithymia Behavior Behavioral Symptoms Fibromyalgia Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Rheumatic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

İstanbul Physical Medicine and Rehabilitation Hospital

Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fibromyalgia Agents

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.

Primary outcomes

  1. 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.

  2. 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).

  3. 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.

Secondary outcomes

  1. Changes in TAS subscales

    Time frame: From enrollment to the end of treatment at 6 months

    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.

Sponsors and collaborators

Lead sponsor

Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Other Gov

Registry information

Official study title

Investigation of Alexithymia Levels in Fibromyalgia Syndrome Before and After Treatment

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Feb 24, 2025
Registry last updated
Feb 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.