COPDNCT06395311
Psychological Distress in Patients With COPD
An observational study of COPD and Quality of Life, run by Spitalul Clinic de Boli Infecțioase și Pneumoftiziologie Dr. Victor Babeș Timișoara at 1 site in Romania.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- COPD, Quality of Life, Mental Health
- What is being tested?
- COPD psychological well-being assessment
- How many people
- 98 participants
- Where
- 1 siteRomania
- Study dates
- 13 May 2024to 1 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Romania1 site
Spitalul de Boli Infectioase si Pneumoftiziologie Victor Babes
Timișoara, Timiș County, 300301
About this study
Official title: The Impact of COPD on Psychological Well-being: A Cross-Sectional Study
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.
Read the 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:
- The Hospital Anxiety and Depression Scale (HADS) to identify and measure the severity of anxiety and depression symptoms.
- The COPD Assessment Test (CAT) to measure the impact of COPD on a person's well-being.
- The State Shame and Guilt Scale (SSGS) to measure a person's shame and guilt.
- The Pulmonary Rehabilitation Adapted Index of Self-Efficacy (PRAISE) to measure the patient's self-efficacy in managing their chronic respiratory disease.
- The Brief Fear of Negative Evaluation Scale (BFNE) to assess an individual's anxiety around being judged or criticized by others.
- The Self-Compassion Scale Short Form (SCS-SF) to measure key components of self-compassion.
- The mMRC scale to evaluate the patient's level of breathlessness (dyspnea) in everyday life.
- The six-minute walking test (6MWT) to measure how far a person can walk on a flat, hard surface in six minutes.
- Conditions
- COPD, Quality of Life, Mental Health, Psychological Distress
- Being tested
- COPD psychological well-being assessment
- Keywords
- COPD, Quality of life, Anxiety and depression, Psychological distress
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Psychological Well-Being, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COPD psychological well-being assessmentOther
Patients 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).
| Study group | Role | What they receive |
|---|---|---|
| COPD subjects | 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: 18 years or older. Adequate visual and/or auditory abilities to read and understand study materials/questionnaires or receive instructions verbally Receives: Other: COPD psychological well-being assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety and depression assessment
The Hospital Anxiety and Depression Scale (HADS) is a self-assessment questionnaire used to identify and measure the severity of anxiety and depression symptoms. It has 14 questions, divided into seven questions assessing anxiety (HADS-A) and seven questions assessing depression (HADS-D). Each question has a 4-point response scale (0-3). Scores of 0-7: normal, scores of 8-10: suggestive of anxiety or depression, and scores of 11+ indicate probable presence of anxiety or depression.
Measured: At inclusion
Impact of COPD
The COPD Assessment Test (CAT) is a questionnaire designed to measure the impact of COPD on a person's well-being. It consists of 8 simple questions. Each question has a 6-point scale (0-5) for the patient to rate their experience. Total scores range from 0 to 40. Higher scores indicate a greater negative impact of COPD on a person's life.
Measured: At inclusion
Shame and guilt assessment
The State Shame and Guilt Scale (SSGS) is a self-report questionnaire that measures a person's shame and guilt. It has 15 questions in total, divided into three subscales: shame (5 questions), guilt (5 questions), and pride (5 questions), which measures the opposite of shame and guilt. Each item has a 5-point Likert scale ranging from 1 (not feeling in this way) to 5 (feeling this way very strongly). Higher scores on each subscale mean individuals experience those feelings more strongly in the moment.
Measured: At inclusion
Self-efficacy assessment
The Pulmonary Rehabilitation Adapted Index of Self-Efficacy (PRAISE) is a questionnaire designed to measure a patient's self-efficacy in managing their chronic respiratory disease, particularly within the context of pulmonary rehabilitation. It has 12 questions focused on managing breathlessness, staying physically active, and coping with emotional challenges due to respiratory disease. Patients rate their confidence on a scale of 1 to 10. Higher scores indicate greater self-efficacy.
Measured: At inclusion
Fear of negative evaluation assessment
The Brief Fear of Negative Evaluation Scale (BFNE) is a psychological tool used to assess an individual's anxiety around being judged or criticized by others. It consists of 12 items. Statements capture different aspects of fear of negative evaluation. The scale uses a Likert scale response format (e.g., 1 = Not at all characteristic of me, 5 = Extremely characteristic of me). Scores are calculated by summing the responses to each item. Higher scores indicate a greater fear of negative evaluation.
Measured: At inclusion
Self-compassion assessment
The Self-Compassion Scale Short Form (SCS-SF) is designed to measure key components of self-compassion. It consists of 12 items. Two items measure each of the six aspects of self-compassion: self-kindness, self-judgment, common humanity, isolation, mindfulness, and over-identification. It uses a 5-point Likert scale (1 = almost never to 5 = almost always). A total self-compassion score is calculated. Higher scores indicate greater self-compassion.
Measured: At inclusion
Dyspnea assessment
The mMRC scale is a simple questionnaire that grades a patient's level of breathlessness (dyspnea) in everyday life. It has five grades (0-4). The patient selects the statement that best aligns with their experience of breathlessness. Higher scores on the mMRC scale correlate to an increased level of disability for the patient due to breathlessness.
Measured: At inclusion
Aerobic capacity assessment
The six-minute walking test (6MWT) measures how far a person can walk on a flat, hard surface in six minutes. It is used to assess aerobic capacity and functional endurance (how well the body can handle activity). The distance walked in 6 minutes is compared with predicted values based on age, gender, and height. A shorter walking distance indicates a lower level of functional exercise capacity.
Measured: At inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2024
- Study start13 May 2024
- Primary completion31 Oct 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spitalul Clinic de Boli Infecțioase și Pneumoftiziologie Dr. Victor Babeș Timișoara
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Crisan Alexandru Florian, Spitalul Clinic de Boli Infecțioase și Pneumoftiziologie Dr. Victor Babeș Timișoara
- Investigators
- Alexandru Crișan, PhD, Principal investigator, Spitalul Clinic de Boli Infecțioase și Pneumoftiziologie Dr. Victor Babeș Timișoara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06395311
- Sponsor's protocol ID
- 2045/11.03.2024
- Status last verified
- Dec 2024
- First submitted
- 24 Apr 2024
- Last updated
- 3 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of COPD on Psychological Well-being: A Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT06395311
- Acronym / sponsor ID
- 2045/11.03.2024
- Conditions
- COPD, Quality of Life, Mental Health, Psychological Distress
- Keywords
- COPD, Quality of life, Anxiety and depression, Psychological distress
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Spitalul Clinic de Boli Infecțioase și Pneumoftiziologie Dr. Victor Babeș TimișoaraOther government
- Study start
- 13 May 2024 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 2 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- The Hospital Anxiety and Depression Scale (HADS) to identify and measure the severity of anxiety and depression symptoms.
- The COPD Assessment Test (CAT) to measure the impact of COPD on a person's well-being.
- The State Shame and Guilt Scale (SSGS) to measure a person's shame and guilt.
- The Pulmonary Rehabilitation Adapted Index of Self-Efficacy (PRAISE) to measure the patient's self-efficacy in managing their chronic respiratory disease.
- The Brief Fear of Negative Evaluation Scale (BFNE) to assess an individual's anxiety around being judged or criticized by others.
- The Self-Compassion Scale Short Form (SCS-SF) to measure key components of self-compassion.
- The mMRC scale to evaluate the patient's level of breathlessness (dyspnea) in everyday life.
- The six-minute walking test (6MWT) to measure how far a person can walk on a flat, hard surface in six minutes.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COPD subjects | – | Other: COPD psychological well-being assessmentDiagnosis 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: 18 years or older. Adequate visual and/or auditory abilities to read and understand study materials/questionnaires or receive instructions verbally |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COPD 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). | Other | COPD subjects |
Primary outcome
Anxiety and depression assessment
Time frame: At inclusion
The Hospital Anxiety and Depression Scale (HADS) is a self-assessment questionnaire used to identify and measure the severity of anxiety and depression symptoms. It has 14 questions, divided into seven questions assessing anxiety (HADS-A) and seven questions assessing depression (HADS-D). Each question has a 4-point response scale (0-3). Scores of 0-7: normal, scores of 8-10: suggestive of anxiety or depression, and scores of 11+ indicate probable presence of anxiety or depression.
Impact of COPD
Time frame: At inclusion
The COPD Assessment Test (CAT) is a questionnaire designed to measure the impact of COPD on a person's well-being. It consists of 8 simple questions. Each question has a 6-point scale (0-5) for the patient to rate their experience. Total scores range from 0 to 40. Higher scores indicate a greater negative impact of COPD on a person's life.
Shame and guilt assessment
Time frame: At inclusion
The State Shame and Guilt Scale (SSGS) is a self-report questionnaire that measures a person's shame and guilt. It has 15 questions in total, divided into three subscales: shame (5 questions), guilt (5 questions), and pride (5 questions), which measures the opposite of shame and guilt. Each item has a 5-point Likert scale ranging from 1 (not feeling in this way) to 5 (feeling this way very strongly). Higher scores on each subscale mean individuals experience those feelings more strongly in the moment.
Self-efficacy assessment
Time frame: At inclusion
The Pulmonary Rehabilitation Adapted Index of Self-Efficacy (PRAISE) is a questionnaire designed to measure a patient's self-efficacy in managing their chronic respiratory disease, particularly within the context of pulmonary rehabilitation. It has 12 questions focused on managing breathlessness, staying physically active, and coping with emotional challenges due to respiratory disease. Patients rate their confidence on a scale of 1 to 10. Higher scores indicate greater self-efficacy.
Fear of negative evaluation assessment
Time frame: At inclusion
The Brief Fear of Negative Evaluation Scale (BFNE) is a psychological tool used to assess an individual's anxiety around being judged or criticized by others. It consists of 12 items. Statements capture different aspects of fear of negative evaluation. The scale uses a Likert scale response format (e.g., 1 = Not at all characteristic of me, 5 = Extremely characteristic of me). Scores are calculated by summing the responses to each item. Higher scores indicate a greater fear of negative evaluation.
Self-compassion assessment
Time frame: At inclusion
The Self-Compassion Scale Short Form (SCS-SF) is designed to measure key components of self-compassion. It consists of 12 items. Two items measure each of the six aspects of self-compassion: self-kindness, self-judgment, common humanity, isolation, mindfulness, and over-identification. It uses a 5-point Likert scale (1 = almost never to 5 = almost always). A total self-compassion score is calculated. Higher scores indicate greater self-compassion.
Dyspnea assessment
Time frame: At inclusion
The mMRC scale is a simple questionnaire that grades a patient's level of breathlessness (dyspnea) in everyday life. It has five grades (0-4). The patient selects the statement that best aligns with their experience of breathlessness. Higher scores on the mMRC scale correlate to an increased level of disability for the patient due to breathlessness.
Aerobic capacity assessment
Time frame: At inclusion
The six-minute walking test (6MWT) measures how far a person can walk on a flat, hard surface in six minutes. It is used to assess aerobic capacity and functional endurance (how well the body can handle activity). The distance walked in 6 minutes is compared with predicted values based on age, gender, and height. A shorter walking distance indicates a lower level of functional exercise capacity.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexandru Crișan, PhD principal investigator
Spitalul Clinic de Boli Infecțioase și Pneumoftiziologie Dr. Victor Babeș Timișoara
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD and Quality of Life, run by Spitalul Clinic de Boli Infecțioase și Pneumoftiziologie Dr. Victor Babeș Timișoara at 1 site in Romania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Romania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety and depression assessment (time frame: At inclusion). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2024.