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

NCT04726917 | Completed

• 1 other identifier: OpoleUofTech4
• Study Type: observational
• Target: 51
• Locations: 1 country
• Sites: 1

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

Conditions

COPD; Anxiety State; Stress; Depressive Symptoms; Mood Disorders

Keywords

pulmonary rehabilitation; depression; anxiety; stress

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• Six-Minute Walk Test (6MWT)

  10 minutes

• Spirometry Test

  20 minutes

Study Arms (1)

Patients with COPD

Patients qualified for 3-week in-hospital pulmonary rehabilitation

Behavioral: Pulmonary rehabilitation

Interventions

Pulmonary rehabilitation BEHAVIORAL

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

Patients with COPD

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with chronic obstructive pulmonary disease

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Opole University of Technology: lead

Study Sites (1)

Hospital of Ministry of the Interior and Administration

Głuchołazy, Opole Voivodeship, 48-340, Poland

Location

Related Publications (7)

• 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.

  PMID: 23931626 BACKGROUND

• 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.

  PMID: 23399845 BACKGROUND

• 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.

  PMID: 24874610 BACKGROUND

• 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.

  PMID: 28150856 BACKGROUND

• 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.

  PMID: 23585837 BACKGROUND

• 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.

  PMID: 21601717 BACKGROUND

• 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.

  PMID: 25419126 BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Anxiety Disorders; Depression; Mood Disorders

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Jan Szczegielniak, Prof

  Hospital of Ministry of the Interior and Administration

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2021
• First Posted: January 27, 2021
• Study Start: October 1, 2020
• Primary Completion: October 1, 2020
• Study Completion: October 30, 2020
• Last Updated: January 27, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)