NCT06891053Enrolling By Invitation不适用
Studio TIARA: Alessitimia ed Emicrania Cronica
Azienda Sanitaria Locale di Alessandria1 个研究点 分布在 1 个国家目标入组 350 人开始时间: 2022年5月30日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 350
- 试验地点
- 1
- 主要终点
- Degree of alexithymia
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 12 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Degree of alexithymia
时间窗: 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
时间窗: In 3 periods of 30 days each (3 months), which make up the 90-day observation time interval
次要结局
- 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)
研究者
研究点 (1)
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