AsthmaCATAPLASTHMANCT05739708
Psychological Characteristics of Patients With Severe Asthma
A study testing Questionnaires in people with Asthma and Attachment, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial summary
Like any chronic disease, asthma exposes individuals to stressful and threatening situations that require ongoing cognitive, emotional, behavioral and social adaptation. Approximately 5-10% of patients with asthma have a treatment-resistant disease, with frequent emergency room visits and hospitalizations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma, Attachment, Coping Skills
- What is being tested?
- Questionnaires
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 15 Feb 2023to 15 Feb 2024
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient aged ≥ 18 years and followed in the Respiratory Department of the Besançon University Hospital for an asthmatic disease diagnosed for more than 12 months. Will be considered as severe patients, asthma patients with uncontrolled asthma despite high therapeutic pressure (GINA levels 4 and 5) and patients requiring to be controlled high doses of inhaled corticosteroids and long-acting beta-2-agonists (or anti-leukotriene/theophylline) in the past year or systemic corticosteroid therapy (>50% in the previous year) (ATS-ERS 2014 criteria).
- Patient able to understand the objectives of the research
- Patient who has signed a research consent form
- Patient affiliated to a French social security system or beneficiary of such a system
Who cannot join
- Patient with reading and comprehension difficulties that prevent them from completing the questionnaires
- Motor disability that prevents the patient from completing the questionnaires
- Legal incapacity or limited legal capacity
- Subject unlikely to cooperate with the study and/or poor cooperation anticipated by the the investigator
- Subject without health insurance
- Subject under court protection, guardianship, conservatorship, or protective supervision. protection.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU de Besançon - Service de Pneumologie
Besançon, Doubs, 25000
Lucie Laurent, PhD, 0381669293 ext. +33, llaurent@chu-besancon.fr
About this study
Like any chronic disease, asthma exposes individuals to stressful and threatening situations that require ongoing cognitive, emotional, behavioral and social adaptation. Approximately 5-10% of patients with asthma have a treatment-resistant disease, with frequent emergency room visits and hospitalizations. These patients are responsible for the majority of the overall asthma-related disease burden and also represent more than half of the total direct costs of asthma management. The scientific literature shows that personality traits, attachment type and psychological disorders will significantly influence disease coping strategies, disease experience, quality of life, adherence and therapeutic alliance. Although some data exist in asthma, there are currently no studies that have evaluated the overall psychological profile of asthma patients, and we have no data specifically on the population of severe asthmatics, who are the most difficult to manage. A better understanding of the overall psychological dimension of asthma patients will make it possible to offer therapeutic education programs that are more targeted according to the psychosocial skills of the patient and finally improve the overall management of the disease.
- Conditions
- Asthma, Attachment, Coping Skills, Personality Trait
- Being tested
- Questionnaires
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesOther
Also called Asthma Coping List (French version), Big Five Inventory (French version), Relationship Scales Questionnaire (French version), Hospital Anxiety and Depression Scale (French version)
The time to complete the different questionnaires is estimated to be 60 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Asthma patients | Other | Not described Receives: Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Description of the psychological profile of severe asthma patients
Score on questionnaires assessing coping strategies (ACL-F)
Measured: 1 day
Description of the psychological profile of severe asthma patients
Score on questionnaire personality traits (BFI-Fr)
Measured: 1 day
Description of the psychological profile of severe asthma patients
Score on questionnaire attachment types (RSQ)
Measured: 1 day
Description of the psychological profile of severe asthma patients
Score on questionnaire anxiety and depression (HADS)
Measured: 1 day
Description of the psychological profile of severe asthma patients
Score on questionnaire quality of life (AQLQ)
Measured: 1 day
Description of the psychological profile of severe asthma patients
Score on questionnaire patient-physician therapeutic alliance (WAI-SR)
Measured: 1 day
Description of the psychological profile of severe asthma patients
Score on questionnaire 0Asthma Control Test (ACT)
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2023
- Study start15 Feb 2023
- Primary completion15 Feb 2024 (estimated)
- Study completion15 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 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
- NCT05739708
- Sponsor's protocol ID
- 2022/727
- Acronym
- CATAPLASTHMA
- Status last verified
- Feb 2024
- First submitted
- 2 Feb 2023
- Last updated
- 23 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychological Characteristics of Patients With Severe Asthma
- ClinicalTrials.gov ID
- NCT05739708
- Acronym / sponsor ID
- CATAPLASTHMA / 2022/727
- Conditions
- Asthma, Attachment, Coping Skills, Personality Trait
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- 15 Feb 2023 (actual)
- Primary completion
- 15 Feb 2024 (estimated)
- Study completion
- 15 Feb 2024 (estimated)
- First posted
- 22 Feb 2023 (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.
Like any chronic disease, asthma exposes individuals to stressful and threatening situations that require ongoing cognitive, emotional, behavioral and social adaptation. Approximately 5-10% of patients with asthma have a treatment-resistant disease, with frequent emergency room visits and hospitalizations. These patients are responsible for the majority of the overall asthma-related disease burden and also represent more than half of the total direct costs of asthma management. The scientific literature shows that personality traits, attachment type and psychological disorders will significantly influence disease coping strategies, disease experience, quality of life, adherence and therapeutic alliance. Although some data exist in asthma, there are currently no studies that have evaluated the overall psychological profile of asthma patients, and we have no data specifically on the population of severe asthmatics, who are the most difficult to manage. A better understanding of the overall psychological dimension of asthma patients will make it possible to offer therapeutic education programs that are more targeted according to the psychosocial skills of the patient and finally improve the overall management of the disease.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Asthma patients | Other | Other: Questionnaires |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient aged ≥ 18 years and followed in the Respiratory Department of the Besançon University Hospital for an asthmatic disease diagnosed for more than 12 months. Will be considered as severe patients, asthma patients with uncontrolled asthma despite high therapeutic pressure (GINA levels 4 and 5) and patients requiring to be controlled high doses of inhaled corticosteroids and long-acting beta-2-agonists (or anti-leukotriene/theophylline) in the past year or systemic corticosteroid therapy (>50% in the previous year) (ATS-ERS 2014 criteria).
- Patient able to understand the objectives of the research
- Patient who has signed a research consent form
- Patient affiliated to a French social security system or beneficiary of such a system
Key exclusion criteria (6 listed)
- Patient with reading and comprehension difficulties that prevent them from completing the questionnaires
- Motor disability that prevents the patient from completing the questionnaires
- Legal incapacity or limited legal capacity
- Subject unlikely to cooperate with the study and/or poor cooperation anticipated by the the investigator
- Subject without health insurance
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 |
|---|---|---|
| QuestionnairesAlso: Asthma Coping List (French version), Big Five Inventory (French version), Relationship Scales Questionnaire (French version), Hospital Anxiety and Depression Scale (French version)The time to complete the different questionnaires is estimated to be 60 minutes. | Other | Asthma patients |
Primary outcome
Description of the psychological profile of severe asthma patients
Time frame: 1 day
Score on questionnaires assessing coping strategies (ACL-F)
Description of the psychological profile of severe asthma patients
Time frame: 1 day
Score on questionnaire personality traits (BFI-Fr)
Description of the psychological profile of severe asthma patients
Time frame: 1 day
Score on questionnaire attachment types (RSQ)
Description of the psychological profile of severe asthma patients
Time frame: 1 day
Score on questionnaire anxiety and depression (HADS)
Description of the psychological profile of severe asthma patients
Time frame: 1 day
Score on questionnaire quality of life (AQLQ)
Description of the psychological profile of severe asthma patients
Time frame: 1 day
Score on questionnaire patient-physician therapeutic alliance (WAI-SR)
Description of the psychological profile of severe asthma patients
Time frame: 1 day
Score on questionnaire 0Asthma Control Test (ACT)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Questionnaires in people with Asthma and Attachment, 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 4 inclusion and 6 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 23 Feb 2024. 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 Lucie Laurent, PhD (0381669293 ext. +33, llaurent@chu-besancon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Description of the psychological profile of severe asthma patients (time frame: 1 day). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Feb 2024; AzTrials last refreshed its copy on 7 Nov 2026.