Studio TIARA: Alessitimia ed Emicrania Cronica
Trial Snapshot
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Sponsor
- Enrollment
- 350
- Locations
- 1
- Primary Endpoint
- Degree of alexithymia
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 12 Years to 65 Years (Child, Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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.
Outcomes
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(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)