- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03577548
Influence of Main Psychological and Social Factors on Primary Headaches (CEPHAPSY)
Study Overview
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
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Rose-Angélique BELOT
- Email: rose-angelique.belot@univ-fcomte.fr
Study Contact Backup
- Name: Margaux BOUTELOUP
- Email: margaux.bouteloup@live.fr
Study Locations
-
-
-
Besançon, France, 25000
- Recruiting
- CHU de Besancon
-
Contact:
- Rose-Angélique BELOT
- Email: rose-angelique.belot@univ-fcomte.fr
-
Contact:
- Margaux BOUTELOUP
- Email: margaux.bouteloup@live.fr
-
Principal Investigator:
- Fabrice VUILLIER, MD PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
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
Publications and helpful links
General Publications
- Belot RA, Bouteloup M, Bonnet M, Parmentier AL, Magnin E, Mauny F, Vuillier F. Evaluation of Attachment Style and Social Support in Patients With Severe Migraine. Applications in Doctor-Patient Relationships and Treatment Adherence. Front Neurol. 2021 Jul 12;12:706639. doi: 10.3389/fneur.2021.706639. eCollection 2021.
- Bouteloup M, Belot RA, Noiret N, Sylvestre G, Bertoux M, Magnin E, Vuillier F. Social and emotional cognition in patients with severe migraine consulting in a tertiary headache center: A preliminary study. Rev Neurol (Paris). 2021 Oct;177(8):995-1000. doi: 10.1016/j.neurol.2020.09.013. Epub 2021 Jan 13.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Headache, Migraine
-
The Cleveland ClinicWithdrawnMigraine | Migraine Disorders | Headache Disorders, Primary | Migraine Headache | Migraine Without Aura | Migraine With Aura | Headache, MigraineUnited States
-
Ariston Pharmaceuticals, Inc.UnknownMigraine | Migraine Disorders | Migraine Headache | Migraine Without Aura | Migraine With AuraFinland, Netherlands, United Kingdom
-
Click Therapeutics, Inc.Active, not recruitingMigraine | Headache | Headache, Migraine | Episodic MigraineUnited States
-
Click Therapeutics, Inc.Active, not recruitingMigraine | Headache | Headache, Migraine | Episodic MigraineUnited States
-
Tonix Pharmaceuticals, Inc.PremierCompletedChronic Migraine | Chronic Migraine, Headache | Chronic Migraine Without Aura | Aura MigraineUnited States
-
Danish Headache CenterCompletedHeadache, Migraine | AuraDenmark
-
Danish Headache CenterCompletedMigraine Headache | Migraine Without AuraDenmark
-
Nanfang Hospital, Southern Medical UniversityBrainClos Co., LTD.; Zhuhai Fudan Innovation InstituteNot yet recruitingCluster Headache | Migraine in Children | Tension Headache | Migraine in Adolescence | Primary HeadacheChina
-
Children's Hospital Medical Center, CincinnatiPatient-Centered Outcomes Research InstituteRecruitingMigraine | Migraine Disorders | Headache | Headache Disorders | Chronic Migraine | Migraine Without Aura | Migraine With Aura | Headache, MigraineUnited States
-
Behar, Caren, M.D.UnknownMigraine | Migraine Disorders | Migraine Headache | Acute MigraineUnited States
Clinical Trials on Auto- questionnaires
-
University Hospital, MontpellierUnknownTracheotomised Children | Anxiety of Parents | Depression of ParentsFrance
-
Cliniques universitaires Saint-Luc- Université...Fonds National de la Recherche ScientifiqueNot yet recruitingAlcohol Use Disorder
-
Centre Hospitalier Universitaire DijonCompletedUnresectable Pancreatic AdenocarcinomaFrance
-
University Hospital, MontpellierRecruitingDepression | SuicideFrance
-
University Hospital, BordeauxRecruitingRestless Legs SyndromeFrance
-
University Hospital, MontpellierNot yet recruitingRestless Legs SyndromeFrance
-
Philips RespironicsCompletedObstructive Sleep ApneaUnited States, Germany
-
Philips RespironicsCompletedSleep Disordered Breathing | Sleep Apnea, CentralUnited States
-
MetroHealth Medical CenterResMed; Great Lakes NeuroTechnologies Inc.TerminatedObstructive Sleep ApneaUnited States
-
McGill University Health Centre/Research Institute...Canadian Institutes of Health Research (CIHR); American Thoracic SocietyCompletedParkinson's Disease | Obstructive Sleep ApneaCanada