Anxiety and COPD Evaluation (ACE)

NYU Langone Health

Status: Completed

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Behavioral: Anxiety Inventory for Respiratory Disease (AIR); Behavioral: Hospital Anxiety and Depression Scale (HADS)

Study type: Interventional

Funder types: Other

Identifiers

NCT02740465

15-00336

Details and patient eligibility

About

This prospective, multicenter, cohort study is designed to validate Anxiety Inventory Respiratory Disease questionnaire in patients with Chronic Obstructive Pulmonary Disease (COPD).

The primary purpose of this study is to assess the validity of the Anxiety Inventory Respiratory (AIR) scale in detecting anxiety in relation to the DSM-V criteria in patients with COPD.

• To evaluate associations between COPD symptom scores assessed by the CAT questionnaire and MMRC dyspnea scale and measures of depression and anxiety
• To evaluate associations between physiologic measures of lung function (spirometry) and exercise tolerance (6 minute walk) and measures of depression and anxiety
• To evaluate associations between exacerbations of COPD and the prevalence of anxiety and depression in a cohort of COPD patients

Full description

The goal of the Anxiety and COPD Evaluation (ACE) study is to validate the AIR scale by employing the Mini International Neuropsychiatric Interview to identify anxiety in 200 patients recruited at participating centers from the American Lung Association (ALA) Airways Research Network.

Confidential, not

Enrollment: 200 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Post-bronchodilation FEV1 < 80% of the predictive normal value and FEV1 (forced expiratory volume in one second) / Forced vital capacity(FVC) ratio < 0.7
• Clinically stable COPD as defined by stable maintenance of COPD medications and absence of an exacerbation of symptoms requiring treatment with an antibiotic or corticosteroids

Exclusion criteria

• Exacerbation of respiratory symptoms in the past six weeks that resulted in the need for treatment or hospitalization
• Unstable coronary heart disease such as recent myocardial infarction (within 3 months), untreated arrhythmia, or unstable angina
• Major psychiatric disorders (except for depression and anxiety disorders) such as schizophrenia, schizoaffective, or other disorders that in the opinion of the study physician that would affect study participation
• Montreal Cognitive Assessment (MoCA) < 18
• Disease or condition expected to cause death within six months or inability to perform study procedures, as judged by study physician

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

COPD Patients

Experimental group

Treatment:

Behavioral: Anxiety Inventory for Respiratory Disease (AIR)

Behavioral: Hospital Anxiety and Depression Scale (HADS)