Studio TIARA: Alessitimia ed Emicrania Cronica
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Migraine, Alexithymia. Basic parameters: 12 years — 65 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- Degree of alexithymia [Time frame: In 3 periods of 30 days each (3 months), which make up the 90-day observation time interval]
- Migraine frequency [Time frame: In 3 periods of 30 days each (3 months), which make up the 90-day observation time interval]
Secondary outcome measures (2)
- 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]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
Italy · 1 center
- Azienda Sanitaria Locale di Alessandria (ASL AL) — Alessandria
Identifiers
NCT: NCT06891053 · Asl22.Neuro.22.01