Influence of Main Psychological and Social Factors on Primary Headaches

Headache, Migraine Clinical Trial

— CEPHAPSY  

Official title:

Influence of Main Psychological and Social Factors on Primary Headaches

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03577548
• Other study ID #: P/2016/290
• Status: Recruiting
• Start date: May 2, 2016
• Est. completion date: August 2018

Study information

• Verified date: July 2018
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: Rose-Angélique BELOT
• Email: rose-angelique.belot[@]univ-fcomte.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study aims to describe the psychological and social characteristics of patients suffering from primary headache and monitored in Neurology department of Besançon University Hospital

Description:

The aim of our study is to describe the psychological patterns in a population of patients suffering of episodic migraine or chronic migraine with and without medication overuse and the level of disability.

Data about migraine characteristics will be obtained using a standardized questionnaire.

Socio-demographic data will be obtained for all patients including gender, age, educational level and professional status.

A booklet of 10 self-administered questionnaires will permit to measure psychological factors such as depression, anxiety, alexithymia...

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: August 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 60 Years

Eligibility

Inclusion Criteria:

• Patients from 25 to 60 ans y.o suffering from primary headache and monitored in the Neurology department of Besançon University Hospital

Exclusion Criteria:

• Patients with former or current psychic troubles

Related Conditions & MeSH terms

• Headache
• Headache, Migraine
• Migraine Disorders

Intervention

Other:
• Auto- questionnaires
10 auto-questionnaires are submitted to the patient during his/her consultation (which is part of the standard care).

Locations

Country	Name	City	State
France	CHU de Besançon	Besançon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Descriptive analysis of socio-demographic questionnaire	Composite outcome assessed with 10 questionnaires are submitted to the patients and all their results are combined in order to identify psychological and social characteristics of the patients: Quantitative variables will be mean, standard deviation, median and minimal/maximal values. Qualitative variables will be described by frequency and proportion of each class.	Day 1
Primary	Descriptive analysis of Short Form 36 (SF 36) Health Survey	Composite outcome assessed with 10 questionnaires are submitted to the patients and all their results are combined in order to identify psychological and social characteristics of the patients: Quantitative variables will be mean, standard deviation, median and minimal/maximal values. Qualitative variables will be described by frequency and proportion of each class.; This questionnaire asseses quality of life.	Day 1
Primary	Descriptive analysis of General Health Questionnaire 12	Composite outcome assessed with 10 questionnaires are submitted to the patients and all their results are combined in order to identify psychological and social characteristics of the patients: Quantitative variables will be mean, standard deviation, median and minimal/maximal values. Qualitative variables will be described by frequency and proportion of each class.; Ranges for this questionnaire: 0 - 1 : no psychological distress / 2 - 3 : psychological problems / 4 - 48 : suspicion of mental illness.	Day 1
Primary	Descriptive analysis of Cungi test	Composite outcome assessed with 10 questionnaires are submitted to the patients and all their results are combined in order to identify psychological and social characteristics of the patients: Quantitative variables will be mean, standard deviation, median and minimal/maximal values. Qualitative variables will be described by frequency and proportion of each class.; Ranges for this questionnaire: 12 - 19 : very low level of stress / 20 - 30 : low level of stress / 31 - 45 : high level of stress / > 45 : very high level of stress.	Day 1
Primary	Descriptive analysis of State-Trait Anxiety Inventory Y-A	Composite outcome assessed with 10 questionnaires are submitted to the patients and all their results are combined in order to identify psychological and social characteristics of the patients: Quantitative variables will be mean, standard deviation, median and minimal/maximal values. Qualitative variables will be described by frequency and proportion of each class.; Ranges for this questionnaire (current anxiety): < 36 : very low / 36 à 45 : low / 46 à 55 : medium / 56 à 65 : high / > 65 : very high.	Day 1
Primary	Descriptive analysis of State-Trait Anxiety Inventory Y-B	Composite outcome assessed with 10 questionnaires are submitted to the patients and all their results are combined in order to identify psychological and social characteristics of the patients: Quantitative variables will be mean, standard deviation, median and minimal/maximal values. Qualitative variables will be described by frequency and proportion of each class.; Ranges for this questionnaire (general anxiety): < 36 : very low / 36 à 45 : low / 46 à 55 : medium / 56 à 65 : high / > 65 : very high.	Day 1
Primary	Descriptive analysis of Beck Depression Inventory	Composite outcome assessed with 10 questionnaires are submitted to the patients and all their results are combined in order to identify psychological and social characteristics of the patients: Quantitative variables will be mean, standard deviation, median and minimal/maximal values. Qualitative variables will be described by frequency and proportion of each class.; Ranges for this questionnaire: 0 - 4 : no depression / 5 - 7 : mild depression / 8 - 15 : moderate depression / > 15 : severe depression.	Day 1
Primary	Descriptive analysis of Social Support Questionnaire 6	Composite outcome assessed with 10 questionnaires are submitted to the patients and all their results are combined in order to identify psychological and social characteristics of the patients: Quantitative variables will be mean, standard deviation, median and minimal/maximal values. Qualitative variables will be described by frequency and proportion of each class.; This questionnaire assesses satisfaction upon social support.	Day 1
Primary	Descriptive analysis of Toronto Alexithymia Scale 20	Composite outcome assessed with 10 questionnaires are submitted to the patients and all their results are combined in order to identify psychological and social characteristics of the patients: Quantitative variables will be mean, standard deviation, median and minimal/maximal values. Qualitative variables will be described by frequency and proportion of each class.; Three levels for alexythimia: < 44 : non-alexithymia / 44 à 55 : possible alexithymia / > 55 : alexithymia.	Day 1
Primary	Descriptive analysis of Bartholomew Relationship Scales Questionnaire	Composite outcome assessed with 10 questionnaires are submitted to the patients and all their results are combined in order to identify psychological and social characteristics of the patients: Quantitative variables will be mean, standard deviation, median and minimal/maximal values. Qualitative variables will be described by frequency and proportion of each class.; Four levels for this questionnaire: Secure, Preoccupied, Dismissing and Fearful.	Day 1