ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03577548
Recruitment Status : Recruiting
First Posted : July 4, 2018
Last Update Posted : July 4, 2018
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment
Headache, Migraine Other: Auto- questionnaires

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
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Influence of Main Psychological and Social Factors on Primary Headaches
Actual Study Start Date : May 2, 2016
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : August 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache


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


Primary Outcome Measures :
  1. 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.


  2. 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.


  3. 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.


  4. 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.


  5. 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.


  6. 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.


  7. 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.


  8. 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.


  9. 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.


  10. 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.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   25 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03577548


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

Locations
France
CHU de Besançon Recruiting
Besançon, France, 25000
Contact: Rose-Angélique BELOT       rose-angelique.belot@univ-fcomte.fr   
Contact: Margaux BOUTELOUP       margaux.bouteloup@live.fr   
Principal Investigator: Fabrice VUILLIER, MD PhD         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Besancon

Responsible Party: Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier: NCT03577548     History of Changes
Other Study ID Numbers: P/2016/290
First Posted: July 4, 2018    Key Record Dates
Last Update Posted: July 4, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Headache
Migraine Disorders
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases