Clinical Trials Directory

Trials / Completed

CompletedNCT06395311

Psychological Distress in Patients With COPD

The Impact of COPD on Psychological Well-being: A Cross-Sectional Study

Status
Completed
Phase
Study type
Observational
Enrollment
98 (actual)
Sponsor
Spitalul Clinic de Boli Infecțioase și Pneumoftiziologie Dr. Victor Babeș Timișoara · Other Government
Sex
All
Age
40 Years – 75 Years
Healthy volunteers

Summary

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.

Detailed description

Chronic obstructive pulmonary disease (COPD) profoundly impacts both physical health and quality of life. Beyond the challenges of breathlessness and functional limitations, COPD patients often struggle with anxiety, depression, and other mental health difficulties at a much higher rate than the general population. This cross-sectional study seeks to understand the current state of psychological well-being in patients with COPD and explore how it relates to the severity of their condition. the study aims to assess the psychological well-being of COPD patients by utilizing 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. Investigators will use the following tests: 1. The Hospital Anxiety and Depression Scale (HADS) to identify and measure the severity of anxiety and depression symptoms. 2. The COPD Assessment Test (CAT) to measure the impact of COPD on a person's well-being. 3. The State Shame and Guilt Scale (SSGS) to measure a person's shame and guilt. 4. The Pulmonary Rehabilitation Adapted Index of Self-Efficacy (PRAISE) to measure the patient's self-efficacy in managing their chronic respiratory disease. 5. The Brief Fear of Negative Evaluation Scale (BFNE) to assess an individual's anxiety around being judged or criticized by others. 6. The Self-Compassion Scale Short Form (SCS-SF) to measure key components of self-compassion. 7. The mMRC scale to evaluate the patient's level of breathlessness (dyspnea) in everyday life. 8. The six-minute walking test (6MWT) to measure how far a person can walk on a flat, hard surface in six minutes.

Conditions

Interventions

TypeNameDescription
OTHERCOPD psychological well-being assessmentPatients will complete the following questionnaires: Hospital Anxiety and Depression Scale (HADS), COPD Assessment Test (CAT), State Shame and Guilt Scale (SSGS), Pulmonary Rehabilitation Adapted Index of Self-Efficacy (PRAISE), Brief Fear of Negative Evaluation Scale (BFNE), Self-Compassion Scale Short Form (SCS-SF). Dyspnea will be evaluated with the mMRC scale, and functional capacity will be assessed with the six-minute walking test (6MWT).

Timeline

Start date
2024-05-13
Primary completion
2024-10-31
Completion
2024-12-01
First posted
2024-05-02
Last updated
2024-12-03

Locations

1 site across 1 country: Romania

Source: ClinicalTrials.gov record NCT06395311. Inclusion in this directory is not an endorsement.