Clinical trial NCT06891677: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: COPD (Chronic Obstructive Pulmonary Disease)
Keywords: COPD
Chronic Obstructive Pulmonary Disease
Internet-based Cognitive Behavioral Therapy
Online CBT
Acceptance and Commitment Therapy
ACT
Educational intervention
Anxiety
Depression
Mental health
Quality of life
Feasibility study
Disease management
Pulmonary rehabilitation
Self-management education
Telehealth
Digital health
Respiratory medicine
Lead sponsor: Region Östergötland
Sponsor class: OTHER
First posted: 2025-03-24
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a single-group feasibility study in which all participants receive the same internet-based cognitive behavioral therapy (CBT) and educational intervention specifically designed for people with COPD. Outcomes will be assessed by comparing measures before and after the intervention on an individual level. Additionally, feasibility aspects such as recruitment rate, acceptability, adherence, and practicality of the intervention will be evaluated. No separate control group is included.
Primary purpose: TREATMENT

Brief summary: 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.


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.

Primary outcomes:
measure: Feasibility of Internet-Based CBT and Educational Intervention for COPD
timeFrame: At completion of the intervention (8-10 weeks)
Secondary outcomes:
measure: Change from Baseline in Depression Symptoms Measured by Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Baseline (before intervention) and immediately after completing the intervention (8-10 weeks)
measure: Change in Anxiety Symptoms Measured by Generalized Anxiety Disorder-7 (GAD-7)
timeFrame: Baseline and after completing the intervention (8-10 weeks)
measure: Change in COPD-Related Quality of Life measured by St. George's Respiratory Questionnaire (SGRQ)
timeFrame: Baseline and immediately after completing the intervention (8-10 weeks)
measure: Change in Health-Related Quality of Life Measured by EuroQol-5 Dimensions (EQ5D)
timeFrame: Baseline and after the intervention (8-10 weeks)
measure: Change in COPD Symptoms and Impact on Daily Life (COPD Assessment Test, CAT)
timeFrame: Baseline and after intervention completion (8-10 weeks)
measure: Change in Breathlessness Severity (Modified Medical Research Council Dyspnea Scale, MRC)
timeFrame: Baseline and immediately after completing the intervention (8-10 weeks)
measure: Change in Perceived Stress (Perceived Stress Scale, PSS-10)
timeFrame: Baseline and after completing the intervention (8-10 weeks)
measure: Change in Physical Capacity (6-Minute Walk Test)
timeFrame: Baseline and after intervention (8-10 weeks)
measure: Change in Lung Function (Spirometry, FEV1 and FVC)
timeFrame: Baseline and immediately after completing the intervention (8-10 weeks)
Other outcomes:
measure: Participant Experiences of the Online Intervention (Qualitative Interviews)
timeFrame: At completion of intervention (8-10 weeks)
Locations:
city: Norrköping
country: Sweden
facility: Lung- och allergimottagningen, Vrinnevisjukhuset
state: Östergötland
Study officials:
affiliation: Region Östergötland
name: Jonas Agholme, Medical Doctor
role: PRINCIPAL_INVESTIGATOR
References: