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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
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Primary Headache Disorder Other: psychological tests Not Applicable

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 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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache

Arm Intervention/treatment
psychological investigation Other: psychological tests
psychological tests psychological interviews
Other Name: psychological interviews




Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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).



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Ages Eligible for Study:   25 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • first consultation in neurology good general somatic state

Exclusion Criteria:

  • Pregnancy History of psychiatric disorder

Information from the National Library of Medicine

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


Contacts
Contact: Rose-Angélique BELOT 0680188113 rose-angelique.belot@univ-fcomte.fr
Contact: Margaux BOUTELOUP 0636924397 margaux.bouteloup@live.fr

Locations
France
Belot Recruiting
Besançon, Doubs, France, 25000
Contact: rose-angelique Belot    0680188113    rose-angelique.belot@univ-fcomte.fr   
Contact: Margaux Bouteloup    0636924397    margaux.bouteloup@live.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire de Besancon

Responsible Party: Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier: NCT03499392     History of Changes
Other Study ID Numbers: P/2017/344
First Posted: April 17, 2018    Key Record Dates
Last Update Posted: April 17, 2018
Last Verified: March 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Centre Hospitalier Universitaire de Besancon:
psychological factors

Additional relevant MeSH terms:
Headache
Headache Disorders
Headache Disorders, Primary
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Brain Diseases
Central Nervous System Diseases