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

Sponsor

The Opole University of Technology (Other)

Overall Status

Completed

CT.gov ID

NCT04726917

Collaborator

(none)

Enrollment

Location

Actual Duration (Days)

53.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
COPD Anxiety State Stress Depressive Symptoms Mood Disorders	Behavioral: Pulmonary rehabilitation

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 Design

Study Type:

Observational

Actual Enrollment :

51 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Oct 1, 2020

Actual Primary Completion Date :

Oct 1, 2020

Actual Study Completion Date :

Oct 30, 2020

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

Hospital Anxiety and Depression Scale (HADS) [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.
Perception of Stress Questionnaire (PSQ) [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.

Secondary Outcome Measures

Six-Minute Walk Test (6MWT) [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.
Spirometry Test [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.