Anxiety and COPD Evaluation

NCT ID: NCT02740465

Last Updated: 2019-03-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2019-03-01

Brief Summary

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

Detailed 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

Conditions

Chronic Obstructive Pulmonary Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

COPD Patients

Group Type: EXPERIMENTAL

Anxiety Inventory for Respiratory Disease (AIR)

Intervention Type: BEHAVIORAL

An initial version of the AIR was developed through a mixed-methods approach to item development, incorporating both emic and etic perspectives. This included an extensive review of extant anxiety scales (etic perspectives) and in-depth qualitative interviews with patients with COPD and self-reported anxiety (emic perspectives). AIR has ten items on a scale from 0 to 3. It provides a score of 0-30. High score indicates elevated level of clinically relevant anxiety symptoms.

Hospital Anxiety and Depression Scale (HADS)

Intervention Type: BEHAVIORAL

The Hospital Anxiety and Depression Scale (HADS), a self-assessment scale, was developed to detect states of depression, anxiety and emotional distress amongst patients who were being treated for a variety of clinical problems.

Interventions

Anxiety Inventory for Respiratory Disease (AIR)

An initial version of the AIR was developed through a mixed-methods approach to item development, incorporating both emic and etic perspectives. This included an extensive review of extant anxiety scales (etic perspectives) and in-depth qualitative interviews with patients with COPD and self-reported anxiety (emic perspectives). AIR has ten items on a scale from 0 to 3. It provides a score of 0-30. High score indicates elevated level of clinically relevant anxiety symptoms.

Intervention Type: BEHAVIORAL

Hospital Anxiety and Depression Scale (HADS)

The Hospital Anxiety and Depression Scale (HADS), a self-assessment scale, was developed to detect states of depression, anxiety and emotional distress amongst patients who were being treated for a variety of clinical problems.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joan Reibman, MD

Role: PRINCIPAL_INVESTIGATOR

New York University Medical School

Locations

New York University School of Medicine

New York, New York, United States

Countries

United States

Other Identifiers

15-00336

Identifier Type: -

Identifier Source: org_study_id