Assessment of Stress Levels and Depressive and Anxiety Symptoms in Patients With COPD

January 26, 2021 updated by: The Opole University of Technology

Assessment of Stress Levels and Depressive and Anxiety Symptoms in Patients With COPD During In-Hospital Pulmonary Rehabilitation: An Observational Cohort Study

The aim of the study was to assess the levels of depression, anxiety and stress in patients with COPD qualified for In-hospital pulmonary rehabilitation program

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Chronic obstructive pulmonary disease (COPD), manifested by coughing, shortness of breath, sputum production, wheezing and reduced physical performance, is one of the most frequently diagnosed lung diseases. Anxiety and depression have been found to increase the number of acute exacerbations and hospitalizations (thus reducing quality of life), weight, appetite, sleep disorders, fatigue or loss of energy, lack of concentration, pessimism about the future and suicidality. Anxiety has been estimated to occur in 21-96% and depression in 27-79% of patients with COPD, values that are higher than for the general population or other chronic diseases. Pulmonary rehabilitation leads to the improvement to the physical capacity and overall fitness of the patients with COPD allowing restoration of independence in daily functioning. Psychological support is required in order to reduce the negative psychological symptoms related to both the pulmonary disease itself and the comorbidities. In the presented study, the aim was to assess the prevalence of levels of depression, anxiety and stress in patients with COPD qualified for In-hospital pulmonary rehabilitation program.

The program includes the following elements:

Three weeks of pulmonary rehabilitation conducted in an outpatient care facility:

  • 5- time a week for 30 minutes a specific respiratory exercises- relaxation exercises for breathing muscles, exercises to increase breathing, prolonged exhalation exercise, chest percussion
  • 5- time a week for 20-30 min training on a cycle ergometer
  • 5- time a week for 30 minutes a fitness and respiratory exercises - coordination and balance exercises, stretching exercises
  • relaxation training by Schultz. The technique involves the daily practice of sessions that last around 15 minutes. During each session, the practitioner repeats a set of visualisations that induce a state of relaxation.

Study Type

Observational

Enrollment (Actual)

51

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
    • Opolskie
      • Głuchołazy, Opolskie, Poland, 48-340
        • Hospital of Ministry of the Interior and Administration

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients diagnosed with chronic obstructive pulmonary disease

Description

Inclusion Criteria:

  • Diagnosed as COPD;
  • Pulmonary rehabilitation conducted in ward settings;

Exclusion Criteria:

  • inability to self-complete the research questionnaires;
  • presence of the following issues at the time of the examination or in the medical data: disturbances of consciousness, psychotic symptoms or other serious psychiatric disorders;
  • initiation of psychiatric treatment during the research project;
  • the patient's refusal at any stage of the research project.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with COPD
Patients qualified for 3-week in-hospital pulmonary rehabilitation
Behavioral: Pulmonary rehabilitation
Patients qualified for rehabilitation were assessed for stress levels as well as symptoms of anxiety and depression before rehabilitation began

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospital Anxiety and Depression Scale (HADS)
Time Frame: 15 minutes
The Hospital Anxiety and Depression Scale (HADS) is a fourteen-item scale scoring from 0 to 3 for each item. The first seven items relate to anxiety (HADS-A), and the remaining seven items relate to depression (HADS-D). The global scoring ranges from 0 to 42 with a cut-off point of 8/21 for anxiety and 8/21 for depression. The higher the score, the greater anxiety or depression symptoms. HADS will be performed at the beginning and after four weeks of treatment.
15 minutes
Perception of Stress Questionnaire (PSQ)
Time Frame: 30 minutes
The Perception of Stress Questionnaire (PSQ) is a 27-item scale scoring from 1 to 5 for each item. 21 items examine the level of stress in the area of emotional tension, external stress and intrapsychic stress, and 6 items refer to the lie scale. The global scoring for perception of stress ranges from 21 to 105 with a cut-off point of 60 for high level of perceived stress. The higher the score, the greater the sense of stress. PSQ will be performed at the beginning and after four weeks of treatment.
30 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Six-Minute Walk Test (6MWT)
Time Frame: 10 minutes
The six-minute walk test measures the distance a patient is able to walk over a total of six minutes on a firm, flat surface. The aim is for the patient to walk as far as possible in six minutes. The patient is allowed to self-pace and rest as needed as they traverse back and forth along a marked walkway.
10 minutes
Spirometry Test
Time Frame: 20 minutes
The patient is asked to take the deepest breath they can, and then exhale into the sensor as hard as possible, for as long as possible, preferably at least 6 seconds. It is sometimes directly followed by a rapid inhalation, in particular when assessing possible upper airway obstruction.
20 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Opole University of Technology

Investigators

  • Study Chair: Jan Szczegielniak, Prof, Hospital of Ministry of the Interior and Administration

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2020

Primary Completion (Actual)

October 1, 2020

Study Completion (Actual)

October 30, 2020

Study Registration Dates

First Submitted

January 23, 2021

First Submitted That Met QC Criteria

January 26, 2021

First Posted (Actual)

January 27, 2021

Study Record Updates

Last Update Posted (Actual)

January 27, 2021

Last Update Submitted That Met QC Criteria

January 26, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OpoleUofTech4

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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