Studio TIARA: Alessitimia ed Emicrania Cronica

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.

Enrolling by Invitation

Interested in participating?

Request Info

Key information

Conditions

Migraine Affective Symptoms Alexithymia Behavior Behavioral Symptoms Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases

Age range

12 year–65 year

Sex eligibility

Female

Study type

Observational

Primary location

Azienda Sanitaria Locale di Alessandria (ASL AL)

Alessandria, Italy, 15121

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Primary outcomes

Degree of alexithymia

Time frame: 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

Time frame: In 3 periods of 30 days each (3 months), which make up the 90-day observation time interval

Secondary outcomes

Number of "drug days" in patients diagnosed with MOH

Time frame: 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

Time frame: In 3 periods of 30 days each (3 months), which make up the 90-day observation time interval

Sponsors and collaborators

Lead sponsor

Azienda Sanitaria Locale di Alessandria

Other

Registry information

Acronym: TIARA

Important dates

Study start: 2022
Primary completion: 2025
Study completion: 2025
First posted: Mar 24, 2025
Registry last updated: Oct 2, 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.

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

Enrolling by Invitation