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Status unknownNCT03499392CEPRIVAUpdated Apr 17, 2018

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

An interventional study of psychological tests in Primary Headache Disorder, sponsored by Centre Hospitalier Universitaire de Besancon. Status unknown at 1 site in France. Open to participants aged 25 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-04-17.

Sponsored by Centre Hospitalier Universitaire de Besancon · Not applicable, Interventional, and Health services research

The sponsor has not verified this record recently (last verified Mar 2018), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
25 Years to 60 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Primary Headache Disorder

Keywords

  • psychological factors
03

Who can participate

Ages eligible
25 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • first consultation in neurology good general somatic state

Exclusion criteria

Exclusion Criteria:

  • Pregnancy History of psychiatric disorder
04

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Other
    psychological investigation

    Other: psychological tests

Interventions

  • Otherpsychological tests

    psychological tests psychological interviews

    Also known as: psychological interviews

05

What researchers measure

Primary outcomes

  1. 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

    Time frame: Month 9

  2. 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

    Time frame: Month 9

Secondary outcomes

  1. 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).

    Time frame: Month 9

06

Study locations

1 of 1 sites recruiting
07

Registry details

Key details

Study ID
NCT03499392
Lead sponsor
Centre Hospitalier Universitaire de Besancon
Responsible party
Sponsor
First posted
Apr 17, 2018
Start date
Apr 30, 2017
Primary completion
Apr 30, 2018 (estimated)
Completion
Sep 30, 2018 (estimated)
Last update
Apr 17, 2018

Study contacts

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

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.

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