Asthma, Smoking, Emotional Deficits

Asthma Clinical Trial

— ASTADEM  

Official title:

Asthma, Smoking, Emotional Deficits

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03312673
• Other study ID #: 69HCL17_0159
• Status: Completed
• Start date: November 22, 2017
• Est. completion date: May 10, 2019

Study information

• Verified date: October 2019
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The objective of the study is to determine whether poor control of asthma is related to an emotional deficit such as alexithymia. The hypothesis is that there is a correlation between the severity of asthma, its control, and the degree of emotional deficits.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: May 10, 2019
• Est. primary completion date: May 10, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Men and women (> 18 years).

• Asthma (mild, moderate, severe).

• Beneficiary of social security

Exclusion Criteria:

• Pregnant women

• Patients who oppose their participation in the study

• Multiple drug users (psychoactive substances).

• Patients with severe psychiatric antecedents and comorbidities.

• Patients with cancer

• Patients with cognitive impairment

• Patients with speech, hearing, visual, and praxic disorders.

• Any chronic and especially respiratory pathology other than asthma (COPD, bronchiectasis), which can alter the study.

• Patients not speaking French

• Persons protected by law

Related Conditions & MeSH terms

• Affective Symptoms
• Alexithymia
• Asthma
• Emotional Disorder

Intervention

Other:
• Interview and tests of drawing.
The intervention will take place with patients followed for asthma at the Croix Rousse hospital. Patients agreeing to participate in the study will come to the hospital for one hour and a half. They will answer questionnaires and tests of drawing. Results Restitution Session (optional) is proposed to patients within the next 4 weeks during a routine consultation.

Locations

Country	Name	City	State
France	Service de Pneumologie Hôpital de la Croix-Rousse	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Poor control of asthma	The poor asthma control is defined by a score <20 on the ACT test	During routine visit (one hour and a half)
Primary	Emotional deficit such as alexithymia	Defined by a score = 44 points/100 on the Toronto scale	During routine visit (one hour and a half)
Primary	Emotional deficit indicator traces	Identifying indicator traces of emotional deficits according to the dimensions defining the alexithymia on the test of the tree and the drawing of the person	During routine visit (one hour and a half)
Primary	Depression	Defined by a score = 11 points on the HADS scale	During routine visit (one hour and a half)
Primary	Anxiety	Defined by a score = 11 points on the HADS scale	During routine visit (one hour and a half)
Primary	Emotional valences	Defined by 8 scores distinct on Diener's subjective well-being scale	During routine visit (one hour and a half)