Headache, MigraineCEPHAPSYNCT03577548
Influence of Main Psychological and Social Factors on Primary Headaches
An observational study of Headache, Migraine, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
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 Read more about this study
- Who is it for?
- Ages 25 to 60 years
- Conditions the study is for
- Headache, Migraine
- What is being tested?
- Auto- questionnaires
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 2 May 2016to Aug 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 60 years
- All sexes
- No healthy volunteers
- Adult
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
Who may be able to join
- Patients from 25 to 60 ans y.o suffering from primary headache and monitored in the Neurology department of Besançon University Hospital
Who cannot join
- Patients with former or current psychic troubles
Trial locations and contacts
1 site in 1 country.
Rose-Angélique BELOT contact
Margaux BOUTELOUP contact
France1 site, 1 recruiting
- Recruiting
CHU de Besançon
Besançon, 25000
Rose-Angélique BELOT, rose-angelique.belot@univ-fcomte.fr
Margaux BOUTELOUP, margaux.bouteloup@live.fr
About this study
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
Read the 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...
- Conditions
- Headache, Migraine
- Being tested
- Auto- questionnaires
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auto- questionnairesOther
10 auto-questionnaires are submitted to the patient during his/her consultation (which is part of the standard care).
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1
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.
Measured: Day 1
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.
Measured: Day 1
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.
Measured: Day 1
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.
Measured: Day 1
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.
Measured: Day 1
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.
Measured: Day 1
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.
Measured: Day 1
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.
Measured: Day 1
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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2018
- Study start2 May 2016
- Primary completionAug 2018 (estimated)
- Study completionAug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Headache, MigraineStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03577548
- Sponsor's protocol ID
- P/2016/290
- Acronym
- CEPHAPSY
- Status last verified
- Jul 2018
- First submitted
- 26 Mar 2018
- Last updated
- 5 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 34322089Bouteloup 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.
PubMed 33454126
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Main Psychological and Social Factors on Primary Headaches
- ClinicalTrials.gov ID
- NCT03577548
- Acronym / sponsor ID
- CEPHAPSY / P/2016/290
- Conditions
- Headache, Migraine
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- 2 May 2016 (actual)
- Primary completion
- Aug 2018 (estimated)
- Study completion
- Aug 2018 (estimated)
- First posted
- 5 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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
Key inclusion criteria (1 listed)
- Patients from 25 to 60 ans y.o suffering from primary headache and monitored in the Neurology department of Besançon University Hospital
Key exclusion criteria (1 listed)
- Patients with former or current psychic troubles
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Auto- questionnaires10 auto-questionnaires are submitted to the patient during his/her consultation (which is part of the standard care). | Other | – |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2018.
- Derived from this study: PubMed 34322089Belot 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.
- Derived from this study: PubMed 33454126Bouteloup 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rose-Angélique BELOT contact
Margaux BOUTELOUP contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Headache, Migraine, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rose-Angélique BELOT (rose-angelique.belot@univ-fcomte.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Descriptive analysis of socio-demographic questionnaire (time frame: Day 1). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03577548, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2018.