Primary Headache and Psychological Factors, Mental Functioning and Attachment Modalities. (CEPRIVA)

April 9, 2018 updated by: Centre Hospitalier Universitaire de Besancon

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

Unknown

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

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 56 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • first consultation in neurology good general somatic state

Exclusion Criteria:

  • Pregnancy History of psychiatric disorder

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Other: psychological tests
psychological tests psychological interviews
Other Names:
  • psychological interviews

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

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Besancon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 30, 2017

Primary Completion (Anticipated)

April 30, 2018

Study Completion (Anticipated)

September 30, 2018

Study Registration Dates

First Submitted

January 16, 2018

First Submitted That Met QC Criteria

April 9, 2018

First Posted (Actual)

April 17, 2018

Study Record Updates

Last Update Posted (Actual)

April 17, 2018

Last Update Submitted That Met QC Criteria

April 9, 2018

Last Verified

March 1, 2018

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

No

Studies a U.S. FDA-regulated device product

No

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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