Primary Headache and Psychological Factors, Mental Functioning and Attachment Modalities.

Primary Headache Disorder Clinical Trial

— CEPRIVA  

Official title:

Primary Headache and Psychological Factors, Mental Functioning and Attachment Modalities.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03499392
• Other study ID #: P/2017/344
• Status: Recruiting
• Phase: N/A
• First received: January 16, 2018
• Last updated: April 9, 2018
• Start date: April 30, 2017
• Est. completion date: September 30, 2018

Study information

• Verified date: March 2018
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: Rose-Angélique BELOT
• Phone: 0680188113
• Email: rose-angelique.belot[@]univ-fcomte.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: September 30, 2018
• Est. primary completion date: April 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 60 Years

Eligibility

Inclusion Criteria:

• first consultation in neurology good general somatic state

Exclusion Criteria:

• Pregnancy History of psychiatric disorder

Related Conditions & MeSH terms

• Headache
• Headache Disorders
• Headache Disorders, Primary
• Primary Headache Disorder

Intervention

Other:
• psychological tests
psychological tests psychological interviews

Locations

Country	Name	City	State
France	Belot	Besançon	Doubs

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of headache attacks	Symptomatic evolution assessed with a composite outcome (number of episodes + severity of headaches) reported by patient and collected during neurological consultation	Month 9
Primary	Duration of each headache attack	Symptomatic evolution assessed with a composite outcome (number of episodes + duration of each episode) reported by patient and collected during neurological consultation	Month 9
Secondary	Definition of patient's psychological profile	Profile is determined by additional semi-structured interviews + Rorschach test + Adult Attachment Interview + mini-Social cognition and Emotional Assesment test (qualitative outcomes).	Month 9