Influence of Main Psychological and Social Factors on Primary Headaches (CEPHAPSY)

July 3, 2018 updated by: Centre Hospitalier Universitaire de Besancon
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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

100

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

25 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All subjects are suffering from primary headache and come for come for a specialized consultation in the Neurology department of Besançon University Hospital

Description

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 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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

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

Sponsor

Centre Hospitalier Universitaire de Besancon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

May 2, 2016

Primary Completion (Anticipated)

August 1, 2018

Study Completion (Anticipated)

August 1, 2018

Study Registration Dates

First Submitted

March 26, 2018

First Submitted That Met QC Criteria

July 3, 2018

First Posted (Actual)

July 5, 2018

Study Record Updates

Last Update Posted (Actual)

July 5, 2018

Last Update Submitted That Met QC Criteria

July 3, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P/2016/290

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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