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Anxiety and COPD Evaluation

NCT02740465 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2019-03-22

No results posted yet for this study

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

Conditions

Interventions

BEHAVIORAL

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.

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.

Sponsors & Collaborators

Principal Investigators

  • Joan Reibman, MD · New York University Medical School

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2019-03-01
Completion
2019-03-01

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02740465 on ClinicalTrials.gov