Influence of Main Psychological and Social Factors on Primary Headaches

• Conditions: Headache, Migraine

• Registration Number: NCT03577548
• Lead Sponsor: Centre Hospitalier Universitaire de Besancon

Brief 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

Detailed 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...

Study Timeline

• Study Start: 2016-05-02
• Study First Submitted: 2018-03-26
• Status Verified: 2018-07
• Study First Submitted QC: 2018-07-03
• Last Update Submitted: 2018-07-03
• Study First Posted: 2018-07-05
• Last Update Posted: 2018-07-05
• Primary Completion: 2018-08
• Study Completion: 2018-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Descriptive analysis of General Health Questionnaire 12	Day 1	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.
Descriptive analysis of Cungi test	Day 1	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.
Descriptive analysis of Toronto Alexithymia Scale 20	Day 1	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.
Descriptive analysis of Bartholomew Relationship Scales Questionnaire	Day 1	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.
Descriptive analysis of State-Trait Anxiety Inventory Y-B	Day 1	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.
Descriptive analysis of Social Support Questionnaire 6	Day 1	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.
Descriptive analysis of State-Trait Anxiety Inventory Y-A	Day 1	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.
Descriptive analysis of socio-demographic questionnaire	Day 1	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.
Descriptive analysis of Short Form 36 (SF 36) Health Survey	Day 1	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.
Descriptive analysis of Beck Depression Inventory	Day 1	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.

Trial Locations

Locations (1)

CHU de Besançon; 🇫🇷 Besançon, France