Primary Headache and Psychological Factors, Mental Functioning and Attachment Modalities.
CEPRIVA
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 30, 2017
CompletedFirst Submitted
Initial submission to the registry
January 16, 2018
CompletedFirst Posted
Study publicly available on registry
April 17, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2018
CompletedApril 17, 2018
March 1, 2018
1 year
January 16, 2018
April 9, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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 Outcomes (1)
Definition of patient's psychological profile
Month 9
Study Arms (1)
psychological investigation
OTHERInterventions
psychological tests psychological interviews
Eligibility Criteria
You may qualify if:
- first consultation in neurology good general somatic state
You may not qualify if:
- Pregnancy History of psychiatric disorder
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Belot
Besançon, Doubs, 25000, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 16, 2018
First Posted
April 17, 2018
Study Start
April 30, 2017
Primary Completion
April 30, 2018
Study Completion
September 30, 2018
Last Updated
April 17, 2018
Record last verified: 2018-03