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

COPD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04726917
• Other study ID #: OpoleUofTech4
• Status: Completed
• Start date: October 1, 2020
• Est. completion date: October 30, 2020

Study information

• Verified date: January 2021
• Source: The Opole University of Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: October 30, 2020
• Est. primary completion date: October 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety Disorders
• Anxiety State
• COPD
• Depression
• Depressive Symptoms
• Mood Disorders
• Stress

Intervention

Behavioral:
• Pulmonary rehabilitation
Patients qualified for rehabilitation were assessed for stress levels as well as symptoms of anxiety and depression before rehabilitation began

Locations

Country	Name	City	State
Poland	Hospital of Ministry of the Interior and Administration	Glucholazy	Opolskie

Sponsors (1)

Lead Sponsor	Collaborator
The Opole University of Technology

Country where clinical trial is conducted

Poland, 

References & Publications (7)

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. — View 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. Review. — View 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. — View Citation

Luk EK, Gorelik A, Irving L, Khan F. Effectiveness of cognitive behavioural therapy in a community-based pulmonary rehabilitation programme: A controlled clinical trial. J Rehabil Med. 2017 Mar 6;49(3):264-269. doi: 10.2340/16501977-2189. — View 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. Review. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospital Anxiety and Depression Scale (HADS)	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
Primary	Perception of Stress Questionnaire (PSQ)	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	Six-Minute Walk Test (6MWT)	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
Secondary	Spirometry Test	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