Asthma, Smoking, Emotional Deficits (ASTADEM)

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.

Study Overview

• Status: Completed
• Conditions: Asthma; Emotional Disorder; Alexithymia
• Intervention / Treatment: Other: Interview and tests of drawing.

• Study Type: Observational
• Enrollment (Actual): 70

Contacts and Locations

Study Locations

• France
  • Lyon, France, 69004
    • Service de Pneumologie Hôpital de la Croix-Rousse

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Asthma sufferers treated at the Croix Rousse hospital

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Asthma population; Patients (men and women) asthmatic smokers and non-smokers followed routinely in the pulmonology department, Croix-Rousse Hospital, Hospices Civils of Lyon.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
Emotional deficit such as alexithymia	Defined by a score ≥ 44 points/100 on the Toronto scale	During routine visit (one hour and a half)
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)
Depression	Defined by a score ≥ 11 points on the HADS scale	During routine visit (one hour and a half)
Anxiety	Defined by a score ≥ 11 points on the HADS scale	During routine visit (one hour and a half)
Emotional valences	Defined by 8 scores distinct on Diener's subjective well-being scale	During routine visit (one hour and a half)

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): November 22, 2017
• Primary Completion (Actual): May 10, 2019
• Study Completion (Actual): May 10, 2019

Study Registration Dates

• First Submitted: October 4, 2017
• First Submitted That Met QC Criteria: October 12, 2017
• First Posted (Actual): October 18, 2017

Study Record Updates

• Last Update Posted (Actual): October 15, 2019
• Last Update Submitted That Met QC Criteria: October 11, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma; Affective Symptoms
• Other Study ID Numbers: 69HCL17_0159

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No