Clinical trial NCT04726917: Assessment of Stress Levels and Depressive and Anxiety Symptoms in Patients With COPD
Official title: Assessment of Stress Levels and Depressive and Anxiety Symptoms in Patients With COPD During In-Hospital Pulmonary Rehabilitation: An Observational Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COPD
Anxiety State
Stress
Depressive Symptoms
Mood Disorders
Keywords: pulmonary rehabilitation
depression
anxiety
stress
Lead sponsor: The Opole University of Technology
Sponsor class: OTHER
First posted: 2021-01-27
Enrollment: 51
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with chronic obstructive pulmonary disease

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: 15 minutes
measure: Perception of Stress Questionnaire (PSQ)
timeFrame: 30 minutes
Secondary outcomes:
measure: Six-Minute Walk Test (6MWT)
timeFrame: 10 minutes
measure: Spirometry Test
timeFrame: 20 minutes
Other outcomes:
Locations:
city: Głuchołazy
country: Poland
facility: Hospital of Ministry of the Interior and Administration
state: Opolskie
Study officials:
affiliation: Hospital of Ministry of the Interior and Administration
name: Jan Szczegielniak, Prof
role: STUDY_CHAIR
References:
citation: Tselebis A, Bratis D, Pachi A, Moussas G, Ilias I, Harikiopoulou M, Theodorakopoulou E, Dumitru S, Kosmas E, Vgontzas A, Siafakas N, Tzanakis N. A pulmonary rehabilitation program reduces levels of anxiety and depression in COPD patients. Multidiscip Respir Med. 2013 Jun 22;8(1):41. doi: 10.1186/2049-6958-8-41.
citation: Bhandari NJ, Jain T, Marolda C, ZuWallack RL. Comprehensive pulmonary rehabilitation results in clinically meaningful improvements in anxiety and depression in patients with chronic obstructive pulmonary disease. J Cardiopulm Rehabil Prev. 2013 Mar-Apr;33(2):123-7. doi: 10.1097/HCR.0b013e31828254d4.
citation: da Costa CC, de Azeredo Lermen C, Colombo C, Canterle DB, Machado ML, Kessler A, Teixeira PJ. Effect of a Pulmonary Rehabilitation Program on the levels of anxiety and depression and on the quality of life of patients with chronic obstructive pulmonary disease. Rev Port Pneumol. 2014 Nov-Dec;20(6):299-304. doi: 10.1016/j.rppneu.2014.03.007. Epub 2014 May 27.
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citation: Coventry PA, Bower P, Keyworth C, Kenning C, Knopp J, Garrett C, Hind D, Malpass A, Dickens C. The effect of complex interventions on depression and anxiety in chronic obstructive pulmonary disease: systematic review and meta-analysis. PLoS One. 2013 Apr 5;8(4):e60532. doi: 10.1371/journal.pone.0060532. Print 2013.
citation: Zhang MW, Ho RC, Cheung MW, Fu E, Mak A. Prevalence of depressive symptoms in patients with chronic obstructive pulmonary disease: a systematic review, meta-analysis and meta-regression. Gen Hosp Psychiatry. 2011 May-Jun;33(3):217-23. doi: 10.1016/j.genhosppsych.2011.03.009. Epub 2011 Apr 27.
citation: Panagioti M, Scott C, Blakemore A, Coventry PA. Overview of the prevalence, impact, and management of depression and anxiety in chronic obstructive pulmonary disease. Int J Chron Obstruct Pulmon Dis. 2014 Nov 13;9:1289-306. doi: 10.2147/COPD.S72073. eCollection 2014.