- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03499392
Primary Headache and Psychological Factors, Mental Functioning and Attachment Modalities. (CEPRIVA)
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.
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: rose-angelique Belot
- Phone Number: 0680188113
- Email: rose-angelique.belot@univ-fcomte.fr
Study Contact Backup
- Name: Margaux Bouteloup
- Phone Number: 0636924397
- Email: margaux.bouteloup@live.fr
Study Locations
-
-
Doubs
-
Besançon, Doubs, France, 25000
- Recruiting
- Belot
-
Contact:
- rose-angelique Belot
- Phone Number: 0680188113
- Email: rose-angelique.belot@univ-fcomte.fr
-
Contact:
- Margaux Bouteloup
- Phone Number: 0636924397
- Email: margaux.bouteloup@live.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- first consultation in neurology good general somatic state
Exclusion Criteria:
- Pregnancy History of psychiatric disorder
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: psychological investigation
|
psychological tests psychological interviews
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Month 9
|
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
|
Month 9
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
Month 9
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- P/2017/344
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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