Studio TIARA: Alessitimia Ed Emicrania Cronica

• Conditions: Migraine; Alexithymia

• Registration Number: NCT06891053
• Lead Sponsor: Azienda Sanitaria Locale di Alessandria

Brief Summary

The aim of this observational, cross-sectional study is to investigate the relationship between alexithymia and migraine frequency (considering alexithymia a condition that can influence the severity of the clinical phenotype of migraine, favoring its chronicization), in an analysis adjusted for psychiatric comorbidity (for anxiety and depression, potentially influencing migraine chronicization) and for personalogical factor represented by apathy.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-05-30
• Status Verified: 2025-03
• Study First Submitted: 2025-03-12
• Study First Submitted QC: 2025-03-21
• Last Update Submitted: 2025-03-21
• Study First Posted: 2025-03-24
• Last Update Posted: 2025-03-24
• Primary Completion: 2025-05-30
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: Female
• Target Recruitment: 350

Inclusion Criteria

• Diagnosis of episodic migraine with or without aura, chronic migraine and/or MOH according to ICHD-3 2018 criteria;
• Patients aged 12-65 years;
• Female patients

Exclusion Criteria

• Ongoing major depressive episode;
• Comorbidities for major internal diseases (hepatopathy, nephropathy, heart failure, etc.);
• Alcohol or substance abuse disorder (eoin, cocaine, cannabis, hallucinogens);
• Language barrier;
• Low cultural/cognitive level;
• No informed consent.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Degree of alexithymia	In 3 periods of 30 days each (3 months), which make up the 90-day observation time interval	Independent variable measured as a score on the TAS-20 scale
Migraine frequency	In 3 periods of 30 days each (3 months), which make up the 90-day observation time interval

Secondary Outcome Measures

Name	Time	Method
Number of "drug days" in patients diagnosed with MOH	In 3 periods of 30 days each (3 months), which make up the 90-day observation time interval
Degree of alessithymia in patients diagnosed with MOH	In 3 periods of 30 days each (3 months), which make up the 90-day observation time interval

Trial Locations

Locations (1)

Azienda Sanitaria Locale di Alessandria (ASL AL); 🇮🇹 Alessandria, Italy