Primary Headache and Psychological Factors, Mental Functioning and Attachment Modalities. (CEPRIVA)
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|ClinicalTrials.gov Identifier: NCT03499392|
Recruitment Status : Recruiting
First Posted : April 17, 2018
Last Update Posted : April 17, 2018
The World Health Organization (WHO) ranks headache among the top 20 causes of disability in the world.
Primary headaches (with no known organic cause) account for 90% of these conditions. INSERM estimates that 15% of the general population is concerned. WHO estimates that 1.7-4% of the global adult population is affected by headache for at least 15 days a month. Headaches are disabling, for patients (pain, suffering, fatigue, unavailability ...) but also for society (socio-economic cost as frequent work stoppages and drug costs). They are a public health problem.
In 2002, the High Authority of Health published its recommendations for the diagnosis and management of migraine patients. In addition, the French Society for Migraine and Headache Studies updated these recommendations in 2013. They are focused on the medical management offered by doctors and pharmacists. However, the professionals in daily contact with the subjects know that the dimension psychic plays an important role in the etiology of headaches.
|Condition or disease||Intervention/treatment||Phase|
|Primary Headache Disorder||Other: psychological tests||Not Applicable|
The review of the literature shows the keen interest and the need for this type of research to better understand the main psychological factors involved in primary headaches.
The current vagueness, the lack of knowledge regarding the aspects associated psychological and the lack of studies on the French population can be filled with this study which takes place at the University Hospital of Besançon.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Primary Headache and Psychological Factors, Mental Functioning and Attachment Modalities.|
|Actual Study Start Date :||April 30, 2017|
|Estimated Primary Completion Date :||April 30, 2018|
|Estimated Study Completion Date :||September 30, 2018|
Other: psychological tests
psychological tests psychological interviews
Other Name: psychological interviews
- Number of headache attacks [ Time Frame: Month 9 ]Symptomatic evolution assessed with a composite outcome (number of episodes + severity of headaches) reported by patient and collected during neurological consultation
- Duration of each headache attack [ Time Frame: Month 9 ]Symptomatic evolution assessed with a composite outcome (number of episodes + duration of each episode) reported by patient and collected during neurological consultation
- Definition of patient's psychological profile [ Time Frame: Month 9 ]Profile is determined by additional semi-structured interviews + Rorschach test + Adult Attachment Interview + mini-Social cognition and Emotional Assesment test (qualitative outcomes).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03499392
|Contact: Rose-Angélique BELOTfirstname.lastname@example.org|
|Contact: Margaux BOUTELOUPemail@example.com|
|Besançon, Doubs, France, 25000|
|Contact: rose-angelique Belot 0680188113 firstname.lastname@example.org|
|Contact: Margaux Bouteloup 0636924397 email@example.com|