NCT06395311Completed
Psychological Distress in Patients With COPD
The Impact of COPD on Psychological Well-being: A Cross-Sectional Study
Source: ClinicalTrials.gov · Last updated 3 Dec 2024
Brief summary (registry, in English)
Chronic obstructive pulmonary disease (COPD) can significantly impact a person's quality of life, not only physically but also mentally. This cross-sectional study aims to assess the psychological well-being of COPD patients by utilising specific questionnaires. These questionnaires will evaluate various aspects of mental health, including anxiety, depression, and potentially other relevant factors like self-compassion or fear of negative evaluation, self-efficacy, shame, and guilt. Additionally, the study will examine how these psychological factors relate to the severity of COPD symptoms, such as dyspnea and functional limitations. By understanding the psychological impact of COPD, this research hopes to emphasize the importance of medical education and mental health support in COPD management strategies.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 98 (actual)
- First submitted
- 24 Apr 2024
- Start date
- 13 May 2024
- Primary completion date
- 31 Oct 2024
- Lead sponsor
- Spitalul Clinic de Boli Infecțioase și Pneumoftiziologie Dr. Victor Babeș Timișoara
- Diseases
- COPD
- NCT number
- NCT06395311
What you commit to
- Study type: Observational
- Participants enrolled: 98
- From 13 May 2024 to the primary completion date, 31 Oct 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Problematic substance abuse: current problematic alcohol or illicit drug use (including opioids).
Other illness
- Other major respiratory illnesses: diagnosis of severe asthma, cystic fibrosis, lung cancer, or other significant respiratory diseases that could present with distinct psychological profiles.
- Unstable comorbid conditions: the presence of severe, uncontrolled medical conditions that could significantly affect cognitive function, well-being, or the ability to participate (e.g., unstable heart failure, end-stage renal disease, rapidly progressing malignancy).
- Severe mental disorders: current or recent diagnosis of a major psychiatric disorder that could significantly interfere with the interpretation of psychological measures or the ability to provide reliable responses (e.g., active schizophrenia, bipolar disorder, a major depressive episode).
Other
- Acute COPD exacerbation: experiencing an acute exacerbation of COPD symptoms within the past four weeks.
- Inability to provide informed consent: individuals lacking the cognitive capacity to understand the study and provide consent.
- Limited language proficiency: insufficient understanding of the language in which the study materials, including questionnaires, are administered.
Who the study is looking for
- Diagnosis of COPD established by a qualified healthcare professional (e.g., pulmonologist, general practitioner) based on:
- Post-bronchodilator spirometry demonstrating airflow obstruction (FEV1/FVC \< 0.70) following GOLD (Global Initiative for Chronic Obstructive Lung Disease) guidelines.
- Age: 40 years or older.
- Adequate visual and/or auditory abilities to read and understand study materials and questionnaires or receive instructions verbally if needed.
Age in the registry: 40 years to 75 years · Sex: All
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Spitalul de Boli Infectioase si Pneumoftiziologie Victor Babes Coordinator of this site? Confirm its status | Timișoara | Romania | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.