Internet-Based Cognitive Behavioral Therapy and Educational Program for People Living With Chronic Obstructive Pulmonary Disease (COPD)

Официальное название

COPD BALANCE: A Feasibility Study of Internet-Based Cognitive Behavioral Therapy and Educational Intervention to Improve Mental Health, Disease Knowledge, and Quality of Life in Patients With Chronic Obstructive Pulmonary Disease

Обзор

The goal of this clinical trial is to learn if an internet-based cognitive behavioral therapy (CBT) and education program can help improve mental health, disease knowledge, and quality of life in adults with chronic obstructive pulmonary disease (COPD). This is a feasibility study, meaning researchers want to find out if this online treatment program is practical, acceptable, and effective enough to use in a larger future study. The main questions it aims to answer are: Can internet-based CBT and disease education help participants feel less anxious, depressed, or stressed? Can this online program help participants better manage COPD symptoms and improve their quality of life? How easy and acceptable do participants find the online CBT and educational program? Researchers will measure the following outcomes to see how well the program works: Quantitative outcomes (using questionnaires and tests): Depression symptoms (using Patient Health Questionnaire-9, PHQ-9) Anxiety symptoms (using Generalized Anxiety Disorder-7, GAD-7) Stress levels (using Perceived Stress Scale, PSS) Quality of life related to COPD (using St. George's Respiratory Questionnaire, SGRQ, and EuroQol-5 Dimensions, EQ5D) COPD-specific symptoms and impact on daily life (using COPD Assessment Test, CAT) Breathlessness severity during daily activities (using Modified Medical Research Council Dyspnea Scale, MRC) Physical capacity (using a 6-minute walk test) Lung function (using spirometry, a breathing test) Qualitative outcomes (using interviews): Participants' experiences and satisfaction with the internet-based therapy and education What participants think helps or hinders them from engaging with the online program How the program affects participants' daily lives and how they cope with COPD Participants in the study will: Take part in an internet-based CBT and education program designed specifically for COPD lasting 8-10 weeks. They can complete the program from home. Answer questionnaires about mental health, stress, quality of life, COPD symptoms, and breathlessness before and after completing the program. Visit the clinic two times (before and after the program) for breathing tests (spirometry) and physical capacity tests (6-minute walking test). Some participants (10-15) will also participate in an interview to discuss their experiences and how they feel about the online treatment program. The results of this study will help researchers understand whether internet-based CBT and COPD education is helpful and practical enough to study in a larger clinical trial in the future.

Вмешательства

• Поведенческое Internet-Based Cognitive Behavioral Therapy (CBT) with ACT and COPD Education
  Participants receive an internet-based cognitive behavioral therapy (CBT) intervention combined with education specifically developed for COPD. The CBT program includes Acceptance and Commitment Therapy (ACT) components. The intervention lasts 8-10 weeks and consists of several online modules. Modules cover topics such as coping strategies, mindfulness techniques, disease knowledge, and symptom management. Participants complete the modules at home via a secure online platform, with regular suppo

Первичные конечные точки

• Feasibility of Internet-Based CBT and Educational Intervention for COPD [Срок оценки: At completion of the intervention (8-10 weeks)]

Вторичные конечные точки (9)

• Change from Baseline in Depression Symptoms Measured by Patient Health Questionnaire-9 (PHQ-9) [Срок оценки: Baseline (before intervention) and immediately after completing the intervention (8-10 weeks)]
• Change in Anxiety Symptoms Measured by Generalized Anxiety Disorder-7 (GAD-7) [Срок оценки: Baseline and after completing the intervention (8-10 weeks)]
• Change in COPD-Related Quality of Life measured by St. George's Respiratory Questionnaire (SGRQ) [Срок оценки: Baseline and immediately after completing the intervention (8-10 weeks)]
• Change in Health-Related Quality of Life Measured by EuroQol-5 Dimensions (EQ5D) [Срок оценки: Baseline and after the intervention (8-10 weeks)]
• Change in COPD Symptoms and Impact on Daily Life (COPD Assessment Test, CAT) [Срок оценки: Baseline and after intervention completion (8-10 weeks)]
• Change in Breathlessness Severity (Modified Medical Research Council Dyspnea Scale, MRC) [Срок оценки: Baseline and immediately after completing the intervention (8-10 weeks)]
• Change in Perceived Stress (Perceived Stress Scale, PSS-10) [Срок оценки: Baseline and after completing the intervention (8-10 weeks)]
• Change in Physical Capacity (6-Minute Walk Test) [Срок оценки: Baseline and after intervention (8-10 weeks)]
• Change in Lung Function (Spirometry, FEV1 and FVC) [Срок оценки: Baseline and immediately after completing the intervention (8-10 weeks)]

Критерии участия

Критерии включения

• Diagnosis of Chronic Obstructive Pulmonary Disease (COPD).
• Access to a computer and stable internet connection.

Критерии исключения

• Significant psychiatric illness requiring specialist psychiatric treatment by healthcare services within the last five years.
• Life expectancy less than six months.
• Dementia or cognitive impairment affecting the ability to participate.
• Limited proficiency in the Swedish language.
• Disabilities preventing computer use.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Швеция · 1 центр

• Lung- och allergimottagningen, Vrinnevisjukhuset — Norrköping

Идентификаторы

NCT: NCT06891677 · Dnr 2024-06453-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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