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OpenTrials
Completed

NCT Number: NCT03312673

Asthma, Smoking, Emotional Deficits

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.

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Key information

Conditions

Asthma Affective Symptoms Alexithymia Behavior Behavioral Symptoms Bronchial Diseases Emotional Disorder Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Service de Pneumologie Hôpital de la Croix-Rousse

Lyon, 69004, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Interview and tests of drawing.

Other

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.

Primary outcomes

  1. Poor control of asthma

    Time frame: During routine visit (one hour and a half)

    The poor asthma control is defined by a score <20 on the ACT test

  2. Emotional deficit such as alexithymia

    Time frame: During routine visit (one hour and a half)

    Defined by a score ≥ 44 points/100 on the Toronto scale

  3. Emotional deficit indicator traces

    Time frame: During routine visit (one hour and a half)

    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

  4. Depression

    Time frame: During routine visit (one hour and a half)

    Defined by a score ≥ 11 points on the HADS scale

  5. Anxiety

    Time frame: During routine visit (one hour and a half)

    Defined by a score ≥ 11 points on the HADS scale

  6. Emotional valences

    Time frame: During routine visit (one hour and a half)

    Defined by 8 scores distinct on Diener's subjective well-being scale

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Acronym: ASTADEM

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Oct 18, 2017
Registry last updated
Oct 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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