Clinical trial NCT06395311: Psychological Distress in Patients With COPD
Official title: The Impact of COPD on Psychological Well-being: A Cross-Sectional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COPD
Quality of Life
Mental Health
Psychological Distress
Keywords: COPD
Quality of life
Anxiety and depression
Psychological distress
Lead sponsor: Spitalul Clinic de Boli Infecțioase și Pneumoftiziologie Dr. Victor Babeș Timișoara
Sponsor class: OTHER_GOV
First posted: 2024-05-02
Enrollment: 98
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Individuals with COPD post-bronchodilator spirometry demonstrating airflow obstruction (FEV1/FVC \< 0.70) following GOLD (Global Initiative for Chronic Obstructive Lung Disease) guidelines.

Brief 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Other major respiratory illnesses: diagnosis of severe asthma, cystic fibrosis, lung cancer, or other significant respiratory diseases that could present with distinct psychological profiles.
* Acute COPD exacerbation: experiencing an acute exacerbation of COPD symptoms within the past four weeks.
* 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).
* Problematic substance abuse: current problematic alcohol or illicit drug use (including opioids).
* 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.

Primary outcomes:
measure: Anxiety and depression assessment
timeFrame: At inclusion
measure: Impact of COPD
timeFrame: At inclusion
measure: Shame and guilt assessment
timeFrame: At inclusion
measure: Self-efficacy assessment
timeFrame: At inclusion
measure: Fear of negative evaluation assessment
timeFrame: At inclusion
measure: Self-compassion assessment
timeFrame: At inclusion
measure: Dyspnea assessment
timeFrame: At inclusion
measure: Aerobic capacity assessment
timeFrame: At inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Timisoara
country: Romania
facility: Spitalul de Boli Infectioase si Pneumoftiziologie Victor Babes
state: Timis
Study officials:
affiliation: Spitalul Clinic de Boli Infecțioase și Pneumoftiziologie Dr. Victor Babeș Timișoara
name: Alexandru Crișan, PhD
role: PRINCIPAL_INVESTIGATOR
References: