Primary Headache and Psychological Factors, Mental Functioning and Attachment Modalities. (CEPRIVA)
Primary Purpose
Primary Headache Disorder
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
psychological tests
Sponsored by
About this trial
This is an interventional health services research trial for Primary Headache Disorder focused on measuring psychological factors
Eligibility Criteria
Inclusion Criteria:
- first consultation in neurology good general somatic state
Exclusion Criteria:
- Pregnancy History of psychiatric disorder
Sites / Locations
- BelotRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
psychological investigation
Arm Description
Outcomes
Primary Outcome Measures
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
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
Secondary Outcome Measures
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).
Full Information
NCT ID
NCT03499392
First Posted
January 16, 2018
Last Updated
April 9, 2018
Sponsor
Centre Hospitalier Universitaire de Besancon
1. Study Identification
Unique Protocol Identification Number
NCT03499392
Brief Title
Primary Headache and Psychological Factors, Mental Functioning and Attachment Modalities.
Acronym
CEPRIVA
Official Title
Primary Headache and Psychological Factors, Mental Functioning and Attachment Modalities.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Unknown status
Study Start Date
April 30, 2017 (Actual)
Primary Completion Date
April 30, 2018 (Anticipated)
Study Completion Date
September 30, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Besancon
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Headache Disorder
Keywords
psychological factors
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
psychological investigation
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
psychological tests
Other Intervention Name(s)
psychological interviews
Intervention Description
psychological tests psychological interviews
Primary Outcome Measure Information:
Title
Number of headache attacks
Description
Symptomatic evolution assessed with a composite outcome (number of episodes + severity of headaches) reported by patient and collected during neurological consultation
Time Frame
Month 9
Title
Duration of each headache attack
Description
Symptomatic evolution assessed with a composite outcome (number of episodes + duration of each episode) reported by patient and collected during neurological consultation
Time Frame
Month 9
Secondary Outcome Measure Information:
Title
Definition of patient's psychological profile
Description
Profile is determined by additional semi-structured interviews + Rorschach test + Adult Attachment Interview + mini-Social cognition and Emotional Assesment test (qualitative outcomes).
Time Frame
Month 9
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
first consultation in neurology good general somatic state
Exclusion Criteria:
Pregnancy History of psychiatric disorder
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rose-Angélique BELOT
Phone
0680188113
Email
rose-angelique.belot@univ-fcomte.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Margaux BOUTELOUP
Phone
0636924397
Email
margaux.bouteloup@live.fr
Facility Information:
Facility Name
Belot
City
Besançon
State/Province
Doubs
ZIP/Postal Code
25000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
rose-angelique Belot
Phone
0680188113
Email
rose-angelique.belot@univ-fcomte.fr
First Name & Middle Initial & Last Name & Degree
Margaux Bouteloup
Phone
0636924397
Email
margaux.bouteloup@live.fr
12. IPD Sharing Statement
Learn more about this trial
Primary Headache and Psychological Factors, Mental Functioning and Attachment Modalities.
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