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

Not Applicable

• Conditions: Primary Headache Disorder
• Interventions: Other: psychological tests

• Registration Number: NCT03499392
• Lead Sponsor: Centre Hospitalier Universitaire de Besancon

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2017-04-30
• Study First Submitted: 2018-01-16
• Status Verified: 2018-03
• Study First Submitted QC: 2018-04-09
• Last Update Submitted: 2018-04-09
• Study First Posted: 2018-04-17
• Last Update Posted: 2018-04-17
• Primary Completion: 2018-04-30
• Study Completion: 2018-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• first consultation in neurology good general somatic state

Exclusion Criteria

• Pregnancy History of psychiatric disorder

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
psychological investigation	psychological tests	-

Primary Outcome Measures

Name	Time	Method
Number of headache attacks	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	Month 9	Symptomatic evolution assessed with a composite outcome (number of episodes + duration of each episode) reported by patient and collected during neurological consultation

Secondary Outcome Measures

Name	Time	Method
Definition of patient's psychological profile	Month 9	Profile is determined by additional semi-structured interviews + Rorschach test + Adult Attachment Interview + mini-Social cognition and Emotional Assesment test (qualitative outcomes).

Trial Locations

Locations (1)

Belot; 🇫🇷 Besançon, Doubs, France