Alexithymia Levels in Fibromyalgia

NCT06841302 | Completed

• 1 other identifier: IstPRMTRH-EK
• Study Type: interventional
• Target: 123
• Locations: 1 country
• Sites: 1

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).

Conditions

Fibromyalgia (FM); Alexithymia

Keywords

Fibromyalgia; Alexithymia; aerobic exercise

Outcome Measures

Primary Outcomes (3)

• 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.

  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).

  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.

  From enrollment to the end of treatment at 6 months

Secondary Outcomes (1)

• Changes in TAS subscales

  From enrollment to the end of treatment at 6 months

Study Arms (1)

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.

Other: Fibromyalgia Agents

Interventions

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.

Patients with Fibromyalgia

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Presence of psychiatric disorders History of antidepressant use

Sponsors & Collaborators

• Istanbul Physical Medicine Rehabilitation Training and Research Hospital: lead

Study Sites (1)

İstanbul Physical Medicine and Rehabilitation Hospital

Istanbul, Turkey (Türkiye)

Location

Related Publications (6)

• 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.

  PMID: 25511201 BACKGROUND

• Sfarlea 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.

  PMID: 31798880 BACKGROUND

• Di Tella M, Castelli L. Alexithymia and fibromyalgia: clinical evidence. Front Psychol. 2013 Dec 2;4:909. doi: 10.3389/fpsyg.2013.00909. eCollection 2013.

  PMID: 24348453 BACKGROUND

• Kleykamp 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.

  PMID: 33383293 BACKGROUND

• Habibi 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.

  PMID: 36471652 BACKGROUND

• Atasoy 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.

  PMID: 41042725 DERIVED

MeSH Terms

Conditions

Fibromyalgia; Affective Symptoms

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: February 18, 2025
• First Posted: February 24, 2025
• Study Start: April 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: February 24, 2025

Record last verified: 2025-02

Locations

TU (1)