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

Official title

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

Overview

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.

Interventions

• Behavioral 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

Primary outcome measures

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

Secondary outcome measures (9)

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

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Sweden · 1 center

• Lung- och allergimottagningen, Vrinnevisjukhuset — Norrköping

Identifiers

NCT: NCT06891677 · Dnr 2024-06453-01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗